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European Pharmaceutical Manufacturer November/December 2012
Volume 12 | Issue 08
Front cover image provided courtesy of Optimal Automation: With the release of synTQ® V4.0, process industries such as life science can now use one robust and proven software platform to develop, deploy and manage Process Analytical Technology (PAT).
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CLASSIFIEDS EPM 3
© December 2012. While every attempt has been made to ensure that the information contained within European Pharmaceutical Manufacturer is accurate, the publisher accepts no liability for information published in error, or for views expressed. All rights for European Pharmaceutical Manufacturer are reserved and reproduction in part or whole without written permission is strictly prohibited.
“
Christmas is yet again on the horizon and hopefully the majority of us are beginning to wind down and look forward to a few days’ well-earned break. However — before turning your undivided attention to the festivities at hand — this year’s final instalment of EPM covers a host of highly topical subjects spanning drug delivery to extractables and leachables, making it a valuable read for anyone involved in pharmaceutical manufacturing. Alongside Quality by Design (QbD), continuous manufacturing has in recent years generated significant interest and its investigation by ‘big pharma’ is steadily gaining momentum. The Manufacturing Equipment and Products section features a Case Study on page 10, which
details a feasibility study conducted by Janssen Pharmaceutica as part of its global project to evaluate the advantages of continuous solid dosage manufacturing technologies. At GEA Pharma Systems’ laboratory, using GEA equipment, Janssen has demonstrated the time, cost and agility benefits of continuous tablet production. Mentioned in my previous ‘from the editor’ is the ‘So What’s New’ feature on page 30 of 10 the Ingredients & Contract Services, a collection of monologues from six key 17 representatives at five companies — AndersonBrecon, Hermes Pharma, Hovione, Cargill and AMRI. At CPhI Worldwide 2012/ICSE, these senior ranking employees talked about their companies’ recent achievements and offerings, how they have adapted to keep up with key industry trends and meet their customers’ requirements. Roger Viney, Hovione’s Director of Sales & Business Development, outlines the value added benefits provided by the company’s particle design services in terms of bioavailability enhancement and extendedand controlled release capabilities, while 26 Liesbeth Meeus, Cargill Pharma & Personal Care’s Application Team Leader, discusses a study that has proved the usefulness of Zerose Erythritol as an orally dispersible tablet excipient owing to its favourable offtaste masking, dilution and disintegration properties. Finally, in the Regulatory Affairs column on page 33 — entitled ‘Extractables, Leachables and QbD’ — Dr. Biffignandi highlights the growing concern surrounding end product contamination risks caused by interactions with packaging and considers the proposed application of QbD to lessen or eliminate these risks. And that just about summarises this issue, so all that remains for me to say is I look forward to continuing in my role as EPM’s Editor in 2013 and wish you all a very Happy Christmas.
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eab members
from the editor
Henrik Broholm, Senior Specialist, H. Lundbeck A/S Henrik has been working in the pharmaceutical industry for the last 15 years, mainly in connection with finished goods packaging (blisters, ampoules and containers). At H. Lundbeck, he has gained valuable experience of working at both vendor and customer sites, further extending his pharmaceutical packaging expertise. Henrik is for the most part involved with user requirement specifications, machinery and process qualification and validation, the introduction of new products on packaging lines and incorporating new features as required by authorities, e.g., 2D matrix coding with track and trace and child resistant blisters and packs. James Cartwright, Global Granulation Leader, Particle Generation, Control & Engineering, GlaxoSmithKline James began working within the pharmaceutical industry in 1996. During this time, he has been instrumental in developing and launching three products for various clinical indications spanning acute Otitis Media, Lymphatic Filiarisis and Type II Diabetes Mellitus. James studied Chemistry and Chemical Engineering and is a Fellow of the Royal Society of Chemistry. Dr. Dimitris Dogramatzis, RPh, PhD Dimitris is a registered pharmacist and pharmacologist, whose industry career encompasses medical affairs, marketing, country and regional management positions. Dimitris has served as Regional VP — Northern Europe for SERONO and authored two textbooks entitled ‘Pharmaceutical Marketing: A Practical Guide’ (2001) and ‘Healthcare Biotechnology — A Practical Guide’ (2010). Dr. Dave Doughty, Director of Process Understanding & Control, GlaxoSmithKline In his 30 plus years in the pharmaceutical industry, Dave has a superb track record in leading teams to develop and commercialise products. This is underpinned by his expert knowledge of the science and mechanistic principles of dosage form design and processing, including PAT, manufacturing operations and GMP. Dave has co-authored product and process patents. Product innovations include oral and transdermal dosage forms. Process innovations include compression and coating of tablets and continuous manufacturing methods and associated PAT. Continuous processes include feeding, mixing, granulation, drying, coating and a novel method of manufacturing low-dose, high-potency drugs. John Gamble, Senior Research Scientist, Bristol-Myers Squibb After graduating from the University of Salford in 1998 with a degree in Chemistry with Industrial Experience, John began his career in quality control analysis of parental vaccines, later moving on to physical analysis of inhaled drugs, before arriving at his current position as Senior Research Scientist within the Powder Properties Optimisation group at Bristol-Myers Squibb. John has a keen interest in understanding the interrelationships between the physical properties of drugs and excipients and their subsequent behaviour during formulation and manufacturing. Aidan Mc Nabola, Engineering Director, UCB Group, SCHWARZ PHARMA Ltd Aidan is Engineering Director at Schwarz Pharma Ltd, based in Shannon Co. Clare, Ireland, and is responsible for site infrastructure, engineering systems — including capital projects — utilities, IT and automation on site. Aidan holds a B. Eng Degree in Mechanical Engineering and has more than 23 years experience in primary and secondary manufacturing in the pharmachem and medical device industries. Grégory Poujol, Manufacturing Maintenance Manager, Sanofi Grégory is an ‘Arts et Métiers’ engineer, working for the wellknown French pharmaceutical company Sanofi. Grégory started working in one of the group’s injectable plants in 2003, before moving to a solid form plant as a Project Manager in 2004 to install new process equipment. He later moved to Spain and continues to lead new equipment installation projects at one of the group’s Spanish solid form plants and since 2009 has been in charge of process maintenance and improvements. Grégory has experience of the most well-known providers of solid form equipment. Kostas Saranteas, Senior Director, Process Chemistry and Engineering, Sunovion Pharmaceuticals Inc. Kostas is Senior Director of the Process Chemistry and Engineering Dept. at Sunovion’s R&D Division. He holds BS/MS/PhD degrees in Chemical Engineering and an MS degree in Environmental Engineering. For 15 years, Kostas worked at Polaroid Corp., specialising in batch process equipment modelling, process optimisation and scale-up. For 11 years, Kostas has been employed at Sunovion. He leads cross-functional teams, championing accelerated process development for drug substance and drug product synthesis from laboratory-scale to full-scale manufacturing.
MANUFACTURING PRODUCTS & EQUIPMENT Handheld SORS Instrument Analyses Raw Materials Through Packaging Cobalt Light Systems has introduced RapID, an instrument for the identification of raw materials through the side of the unopened packaging. The pharmaceutical industry spends a significant amount of time verifying the identity of raw materials before they enter the manufacturing process. Accurate QC of these materials is essential and can be very time consuming, expensive and resource intensive. RapID offers significant cost savings because most raw materials can now be accurately identified without even opening the packaging. Cobalt has successfully developed a patented technique known as Spatially Offset Raman Spectroscopy (SORS), which is at the heart of the RapID system. A key advantage of SORS is that it can measure a highly-specific Raman spectrum of APIs and excipients through unopened sacks, bottles, coloured glass and opaque plastic containers. RapID supersedes the entire notion of opening bags or bottles of raw material to take a sample, which is then sent to the QC lab for testing. With RapID, the process of verifying the material and getting it into manufacturing is faster, more cost effective and can be done as soon as the goods hit the loading bay. Operation is by non-scientific personnel, with a
simple, handheld ‘point and shoot’ measurement tool. One hundred per cent testing of raw materials is a regulatory requirement for companies selling products in Europe and is likely to be mandatory in other parts of the world soon. These changes put ever greater demands on manufacturers to find ways of improving efficiencies throughout the value chain.
Thanks to SORS, RapID offers a set of features developed specifically for the validation of pharmaceutical raw materials, while also providing a surprisingly fast return on investment. Cobalt Light Systems Ltd +44 1235 433 187 darren.andrews@cobaltlight.com www.cobaltlight.com
Tool Management Software Ensures Tablet Consistency According to Natoli, its TM-II tool management system is the most efficient software available for managing an entire tooling database. Designed to help tablet manufacturers improve product quality and consistency, TM-II organises critical punch inspection dimensions through a user-friendly, comprehensive tooling database. Increase tablet production and minimise downtime by effectively tracking tool usage in order to prevent the use of bad tools that cause inconsistent tablets and tablet press breakdowns. Save time by updating an entire set of tools at one time and organise tool sets according to the tablets they produce. Track and access a multitude of comprehensive tooling reports related to inspections, measurements, purchase orders, drawings, steel type, machine type and more. Quickly access details and reports on tool usage history, machine press used, lot number, date, quantity, comments and much more. All reports are prepared to meet FDA requirements and can be easily located through a tool query.
To help the customer achieve CFR Part 11 compliance, the TM-II system includes a validation package, database security, electronic audits and more. An optional multi-tip capability is also available to inspect and track multi-tip tooling by tracking the critical dimensions of each individual tip. Reduce labour costs, minimise press downtime and avoid costly surprises by relying on an exceptionally powerful tool control software. Visit Natoli’s website to download a free copy of the TM-II demo software and schedule a no-obligation, one-on-one webinar to learn more.
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Natoli Engineering Company, Inc. +1 636 926 8900 info@natoli.com www.natoli.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Square Pharmaceutical Contracts Entire Development of Oral and Parenteral Product Production Plants
Modular Design of CIP/SIP System Allows for Individual Configuration
Telstar will direct the full execution of two new pharmaceutical plants for the international Bengali company Square Pharmaceuticals Ltd. For the first project, Telstar will manage the construction of a plant for the production of oral solids, consisting of a four-story building of 32,000 m2, with 7 fluidised bed granulation lines, 11 tablet lines, 4 lines for capsules and 16 primary and secondary packaging lines, plus a second service building of 1,000 m2. The second project consists of a 20,000 m2 four-story building for production of parenterals in small- and large-volume formats, including two lines for manufacturing BFS bottles, each with two reactors of 20,000 l, a line for manufacturing glass bottles, one for bags, two for vials, two for preloaded syringes, one for lyophilised vials with two freeze-dryers and one topical aerosol production line. Telstar performed the engineering for both plants and was the winning bidder for the full project administration and provision of the pharmaceutical architecture and the process equipment and critical installations, managing the coordination of local installers for the remaining installations. Start-up and qualification of these new plants is scheduled for the first half of 2013. Square Pharmaceutical’s trust in Telstar as a technological partner is based on its know-how, experience and capability in the development of these types of large scope projects. Since
The standardised compact system from Bosch Packaging Technology for cleaning and sterilisation in place (CIP/SIP) is suitable for pharmaceutical containers and vessels as well as small production accessories, including filter units, mills, pumps and hoses. The modular system is manufactured in Dresden by Pharmatec, a subsidiary of Bosch Packaging Technology. CIP/SIP systems are used for reliable and reproducible cleaning and sterilisation of machinery and equipment. This cleaning and sterilisation process is especially important to ensure the highest product quality for sterile pharmaceuticals. The modular construction of this system is designed to meet virtually all customer requirements quickly and easily. The basic configuration includes a CIP tank to mix the necessary cleaning media, a flow pump, lines for PW (purified water), WFI (water for injection), clean steam and compressed air and the required measurement, control and valve systems. The system can be quickly and easily configured with add-on modules to meet different customer specifications. In addition to a self-priming return pump, a pharmaceutical-compatible heat exchanger can be integrated into the existing CIP frame. The temperature of the cleaning media is controlled via steam or electric heat exchangers. Various dosing stations
2003, Telstar has collaborated with Square on a number of highly complex projects, which involved the development of production installations and plants. Outstanding examples include the new cephalosporin plant built in 2005, the new plant for sterile filling and bottling of pharmaceutical liquids with Blow-Fill-Seal (BFS) technology in 2007, the new insulin production plant in 2010 (with the ability to produce up to 13 million vials of insulin per year) and, finally, the SVPO plant for production of small-volume parenterals and ophthalmology products inaugurated in 2008 in Dhaka. Square Pharmaceuticals is reportedly the largest manufacturer of pharmaceutical products in Bangladesh. With a market share of 16.43%, Square Pharmaceuticals obtained a sales volume of approximately $164 million in 2010. Telstar +34 93 736 16 00 marketing@telstar.eu www.telstar.eu
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for detergent concentrates and sterile air filter units used for blowing out and drying the system can be integrated. “The modular design and the use of proven standard components enable a fast system configuration,” explained Volker Kempf, Project Manager at Pharmatec. “This ensures efficient project execution in the shortest possible time — even when there are additional requirements.” The Dresden plant maintains a supply of all media required in the pharmaceutical industry, including WFI and pure steam, for system pretesting. Along with installation qualification (IQ), the system also enables the implementation of the operational qualification (OQ), including spray pattern control, riboflavin testing and temperature mapping (cold spot analysis). This ensures that the CIP system is in operation very shortly after being delivered to the customer’s site. Cleaning efficiency is regulated by changing specific parameters. Time, temperature, concentration of the cleaning solutions and flow rate must be perfectly matched to achieve optimum results. The Pharmatec CIP system operates at temperatures up to 90˚C, with a flow rate ranging from 500 to 5,000 l per hour. Process steps running in parallel ensure maximum cleaning quality with short cycles. Bosch Packaging Technology +49 351 28278 617 www.boschpackaging.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Multi-Page Labels Provide Almost Unlimited Space for Vital Information Denny Bros is a leading, independent specialist print company and the originator of Fix-a-Form multi-page labels. These labels are used extensively in the pharmaceutical and clinical trial markets as they relay vital product descriptions, dosage and user guidelines and safety messages in multiple languages. As a pharmaceutically accredited company, to the new PS9000 2011 standard, Denny Bros’ processes and people are monitored and assessed
continually to ensure the development of effective, dependable products and provision of exceptional customer care. Denny Bros prides itself in continuously developing its products to meet the industry’s needs but the company also works with its clients to create a bespoke product specific to their needs. The development of the use of 45 gsm paper has also allowed Denny Bros to push the boundaries of the number of pages included within a booklet format
and the company can now offer 80-page and 120-page double booklets. It is not just the choice and quality of products that make Denny Bros an ideal packaging provider but its services, such as alpha numeric and unique random codes and QR codes that can now include URNs and Braille. Denny Bros Ltd +44 1284 701381 fix-a-form@dennybros.com www.dennybros.com
Circular Fluid Bed Dryer Offers Improved Efficiency at Reduced Cost A new 762 mm Vibro-Bed circular fluid bed drying system from Kason increases operating efficiency, cuts cleaning time and reduces cost, according to Henry Alamzad, President. Inherent rigidity of the circular fluid bed processing chamber exceeds that of traditional, rectangular fluid bed processors, allowing materials of construction to be down-gauged and vibratory motors to be downsized. Associated components are also eliminated, such as multiple air inlets and outlets, the circular unit requiring only one of each. As a result, the dryer is said to be lighter, stronger and more energy efficient at equivalent capacities. Reductions in material, weld seams and associated labour decrease fabrication cost, particularly when units are finished to FDA, USDA, BISSC or 3A standards.
Cleaning time is cut in half owing to stainless steel material contact surfaces, reduced weld seams, a quick-disconnect housing and lack of internal cross members, according to the company. Compactness and light weight allow configuring of complete systems or modules containing the blower, heater and programmable controls on skidmounted frames, requiring only on-site connections to a power source, dust collector and material inlet/outlet. Material fed into the top inlet of the dryer descends into the fluid bed chamber where it vibrates on a circular screen within a rising column of heated air ducted into the bottom of the chamber from the upstream heater/blower. The continuous airflow and vibration induced by two vibratory motors and spring suspension, separate and fluidise individual particles,
maximising surface area and drying efficiency. The vibratory action also causes material to travel from the centre of the screen to a discharge spout at the screen’s periphery in controlled spiral pathways on a ‘first in, first out’ basis. The circular fluid processing unit is offered in diameters from 460 to 2,135 mm, encompassing batch and continuous applications from low-capacity laboratory and pilot plant testing to medium-high volume production. All are available configured for drying/heating, cooling or moisturising applications. Available options include: centrifugal screeners to deagglomerate moist incoming material; spray nozzles to coat dried particles; and vibratory screeners to scalp, classify or dedust dried material.
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Kason Corporation +44 1782 597540 sales@kasoneurope.co.uk www.kasoneurope.co.uk
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY Janssen Pharmaceutica, part of the worldwide Janssen Pharmaceutica Group, has initiated a global project with the aim of evaluating technical performance and related business benefits of continuous processing technologies for oral solid dosage forms. In this context, ConsiGma continuous processing technology from GEA Pharma Systems has been assessed for tablet manufacture. During an in-depth feasibility study at GEA Pharma Systems’ laboratory, the team from Janssen has been able to demonstrate the system’s benefits in relation to time, cost and agility. The GEA equipment used in the study included a ConsiGma 25, a multi-purpose platform that, when combined with a Courtoy MODUL P rotary tablet press, processes powder into tablets in development, pilot, clinical and production volumes in a single compact unit. ConsiGma can produce granules continuously, with minimal waste during start-up and shut-down, while determining batch size only by the length of the run. Online quality measurements were taken throughout the process facilitated by the GEA Lighthouse Probe that prevents product sticking to the observation windows of the process analyser. The trial consisted of a series of test runs, including one of ten hours, three repeat runs of five hours to prove repeatability and reproducibility and finally a 16-hour run to assess
JANSSEN PHARMACEUTICA TEAMS UP WITH PROCESS EQUIPMENT SPECIALIST TO INVESTIGATE CONTINUOUS TABLET MANUFACTURE
the overall performance and online measuring techniques. The Critical Quality Attributes (CQAs) measured were moisture, particle size, blend uniformity and content uniformity. A Tandem system by Bruker Optics was used for the online measurement of the CQA’s of the tablets. The Siemens SIPAT system was also selected as an advanced control system to gather and process all the data from the ConsiGma and the different online measurement devices. The outcome of the trials led the Janssen team to conclude that the ConsiGma technology The ConsiGma equipment used in the trial. allows for process development in a very short time for production reduced inventory costs. As a result, obvious cost reduction and for substantial time-to-market business value can be expected from this reduction. The agility of the system has allowed technology. efficient and effective experiment design. The ConsiGma reportedly provides the maximum process stability and robustness was proven output while consuming less of the earth’s through the production of tablets of consistent resources than any other system. It has been tested quality. using over 100 different formulations and is already Janssen believes that more intensive process being used by several large pharmaceutical monitoring and control will create a more stable companies and research establishments worldwide. and consistent process, faster development will lead to cost reductions, a smaller footprint to GEA Pharma Systems nv - Collette reduced investment, online monitoring and real+32 3 350 12 88 time release testing to reduced quality control costs kris.schoeters@geagroup.com and the elimination of intermediate storage to www.geapharmasystems.com
Desiccated Blister Packaging Preserves Moisture- and Oxygen-Sensitive Solid Dose Pharmaceuticals CSP Technologies has announced the global launch of its Activ-Blister desiccated blister packaging for the pharmaceutical industry. Activ-Blister desiccant film technology controls the internal atmosphere of each individual blister cavity, protecting moisture- and oxygen-sensitive solid dose pharmaceuticals. The result is optimised product stability, increased shelflife and greater consumer convenience. Activ-Blister also helps ensure consumer safety because unlike conventional desiccants there is no chance of accidental ingestion. Activ-Blister offers manufacturers superior flexibility in packaging design, providing an opportunity to differentiate their products. By eliminating the need for traditional desiccant tablets in
separate blister wells, Activ-Blister allows for a slimmer, more convenient packaging form-factor, while simplifying the end-user experience. In addition, by featuring product protection without increased blister size, Activ-Blister provides manufacturers with potential cost savings through reduced material usage, freight costs and fuel consumption. “Activ-Blister is an entirely new approach to protecting pharmaceuticals with specialised packaging that can build a unique identity for brands,” according to Dan L’Ecuyer, Vice President of Sales & Marketing at CSP Technologies. CSP’s patented technology integrates precise desiccant, gas-absorption and sealing properties into the blister-pack
itself, extending shelflife and product performance. Activ-Blister exhibits excellent performance capacity with moisture absorption up to 20 mgs and oxygen scavenging up to 30 ccs. In addition, CSP’s Activ-Blister technology is available in a variety of sizes, including all types of round tablets and capsules up to size 0, with either multilayer barrier films or aluminum foil blisters to provide protection from both moisture and oxygen. “Safely preserving drug potency and extending shelflife are high priorities for pharmaceutical manufacturers and for the patients who rely on their products,” said L’Ecuyer. “Activ-Blister provides a strong product solution that meets customer needs, while also safeguarding patient health.”
Stainless Steel Equipment and Furniture Specialist Launches Catalogue Teknomek is celebrating twenty-five years of excellence with the introduction of a new and improved annual product catalogue. Launched in October, the catalogue showcases over 1,500 products from what Teknomek claims is the largest and most comprehensive range of stainless steel hygiene furniture and equipment in the UK. According to the company, the 148-page bumper edition is the new ‘go to guide’ for all things Teknomek, with a bright, clear layout designed for easy
browsing. Products have been divided into 12 sectors for ease of use, with each product having a full description, dimensions and price. Alongside the extensive standard product range, Teknomek also offers a bespoke service where products can be custom-made to meet specific requirements. Its in-house CAD team provides a full design and advisory service to ensure the most cost-effective solution is delivered. A new digital version of the catalogue
is planned, providing an online pageturner at www.teknomek.co.uk from which customers can view the product range, share with colleagues or print off as required. Copies of the catalogue can be obtained by calling or emailing Teknomek. Teknomek Ltd +44 1603 788833 mail@teknomek.co.uk www.teknomek.co.uk
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CSP Technologies, Inc. +1 334 887 8300 info@csptechnologies.com www.csptechnologies.com
BUYERS’ GUIDE TABLET PRESSES Bosch Packaging Technology Ltd, UK
Dott. Bonapace & C. S.r.l., Italy
+44 151 5478000 info.packaging-kny@bosch.com www.boschpackaging.com
+39 02 33122352 r.colombo@dottbonapace.com www.dottbonapace.com
R&D and/or Production Press:
R&D and small-scale production press.
Production press.
R&D and/or Production Press:
R&D and production.
R&D and production.
Applications:
Solid dose manufacturing.
Solid dose manufacturing.
Applications:
Pharmaceutical and nutraceutical.
Pharmaceutical and nutraceutical.
Product Name:
Xpress
Xpress
Product Name:
Single punch tablet press.
Rotary tablet press.
Model:
100
700
Model:
CPR 6
CPR 18
Number of Tablet Layers:
One
Up to two
Number of Tablet Layers:
One
One
Maximum Tablet Diameter (mm):
20 mm
25 mm
Maximum Tablet Diameter (mm):
16 mm
B-16 mm, D-22 mm
Tooling:
Available with B, BB, BBS, D, EU Available with B, BB, BBS, D, EU or IPT. or IPT.
Tooling:
Dedicated one
B, D, TSM, EU, IPT
Depth of Fill/ Charge Depth (mm):
20 mm
21 mm max.
Depth of Fill/ Charge Depth (mm):
17 mm
17.4 mm
Hourly Tablet Production Rate:
4,500–34,500 max.
36,000–1,008,000 max.
Hourly Tablet Production Rate:
2,500
18,000 max.
Pre-Compression up 5 kN to (kg/kN):
100 kN std.
Pre-Compression up N.A. to (kg/kN):
0.5 tonnes
Maximum Compression Force (Tonnes/kN):
60 kN
100 kN std.
Maximum Compression Force (Tonnes/kN):
2.5 tonnes
6 tonnes
Upper Punch Penetration (mm):
Pre-compression — 2 mm, main compression — 3 mm.
1–8 mm
Upper Punch Penetration (mm):
0–8 mm
5 mm
Load/ Thickness Monitor:
Yes
Yes
Load/ Thickness Monitor:
No
No
Additional Info:
Bosch Manesty offers tablet coating systems, plus tablet tooling and spare parts for tablet presses.
Additional Info:
Software for compression data detection available upon request.
Elizabeth Companies / Elizabeth-Hata, US
GEA Pharma Systems - Courtoy, Belgium
+1 412 829 7700 ryank@eliz.com www.eliz.com
+32 2 363 83 00 courtoy@gea.com www.gea-ps.com/courtoy
R&D and/or Production Press:
R&D and production rotary tabletting press.
Production press.
R&D and/or Production Press:
R&D and production.
R&D and production.
Applications:
Pharmaceutical, nutraceutical and confectionary.
Pharmaceutical, nutraceutical and confectionary.
Applications:
Pharmaceutical and nutraceutical.
Pharmaceutical and nutraceutical.
Product Name:
Hata Tri-Layer / Core Tableting Press System
Hata CVX-Series Tableting Press
Product Name:
MODUL
PERFORMA
Model:
HT-CVX-LSU-3/L-Core
HT-CVX-LDU-2/L
Model:
MODUL P
PERFORMA P
Number of Tablet Layers:
Single layer, bi-layer, tri-layer and custom core tabletting.
Single and bi-layer capability.
Number of Tablet Layers:
One and two (bi-layer capability optional).
One and two (bi-layer capability optional).
Maximum Tablet Diameter (mm):
25 mm for D-size tooling configuration.
25 mm for D-size tooling configuration.
Maximum Tablet Diameter (mm):
25.4 mm
25 mm
Tooling:
B, BB or D size, TSM or EU.
B, BB or D size, TSM or EU.
Tooling:
TSM or EU standard.
TSM or EU standard.
Depth of Fill/ Charge Depth (mm):
0–8 mm first layer, 3–9 mm second layer and 6–12 mm third layer.
4–7 mm, 7–14 mm and 11–18 mm.
Depth of Fill/ Charge Depth (mm):
20 mm max.
20 mm max.
Hourly Tablet Production Rate:
286,000 max.
Min. 54,000 to max. 625,000.
Hourly Tablet Production Rate:
244,800 max.
Min. 25,000 to max. 172,000.
Pre-Compression up to (kg/kN):
10 kN max, with extended dwell time.
10 kN max, with extended dwell time.
Maximum Compression Force (Tonnes/kN):
80 kN max.
80 kN max
Upper Punch Penetration (mm):
1–4
1–4
Pre-Compression up 4 tonnes to (kg/kN):
8 tonnes
Maximum Compression Force (Tonnes/kN):
4 tonnes
Upper Punch Penetration (mm):
3 mm fixed for main; 3–8 mm first and second layers.
3 mm fixed.
Multi-Layer Capability:
Up to two layers.
Up to two layers.
Load/ Thickness Monitor:
Yes
Yes
Load/ Thickness Monitor:
Yes
Yes
Additional Info:
Ideal tabletting press for both product development and production batches.
Single layer and bi-layer interchangeable turret with easy clean mechanical features.
Additional Info:
With ECM (Exchangeable Compression Module) — contained, high-containment or wash-off-line execution.
With exchangeable turret and EDD (Exchangeable Die Disc).
8 tonnes
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BUYERS’ GUIDE TABLET PRESSES Natoli Engineering Company, Inc., US
Riva Europe Ltd, UK
+1 636 926 8900 sales@natoli.com www.natoli.com
+44 1252 345923 sales@riva-europe.co.uk www.riva-europe.co.uk
R&D and/or Production Press:
R&D press.
Production press.
R&D and/or Production Press:
R&D and pilot scale GMP production.
R&D and pilot scale GMP production.
Applications:
12 mm
All applications.
Applications:
Pharmaceutical, nutraceutical and chemical.
Pharmaceutical, nutraceutical and chemical.
Product Name:
NP-RD10A
NP-500
Product Name:
Riva Piccola
Riva Compacta
Model:
Nova Bi-Layer
NP-500
Model:
Nova
NP-RD10A
Number of Tablet Layers:
Two
One
Number of Tablet Layers:
Mono
Unlimited
Maximum Tablet Diameter (mm):
25 mm
25 mm
Maximum Tablet Diameter (mm):
25.40 mm
23.81 mm
Tooling:
B B, B, D, TSM or EU.
B B, B, D, TSM or EU.
Tooling:
B, D, F configurations, TSM or EU.
328
Depth of Fill/ Charge Depth (mm):
19 mm
19 mm
Depth of Fill/ Charge Depth (mm):
33.34 mm
1.6–35 mm
Hourly Tablet Production Rate:
60,000 max.
162,000 max.
Hourly Tablet Production Rate:
180
54,000–334,800
Pre-Compression up 5 kN to (kg/kN):
60 kN
Pre-Compression up N.A. to (kg/kN):
N.A.
Maximum Compression Force (Tonnes/kN):
60 kN max.
80 kN
Maximum Compression Force (Tonnes/kN):
10 tonnes
10 tonnes
Upper Punch Penetration (mm):
Up to 14 mm
1–4 mm
Upper Punch Penetration (mm):
12 mm
4.76–11.11 mm
Load/ Thickness Monitor:
Yes
Yes
Load/ Thickness Monitor:
Yes
Yes
Additional Info:
Interchangeable turret, PC HMI and automatic weight control software/hardware.
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SHOWCASE COATING Penn Pharma Selects Perforated Tablet Coaters for Contained Manufacturing Facility Penn Pharma’s new, 1,400 m2 contained manufacturing operation will be operational early in 2013. The purposebuilt facility will utilise cutting- edge technology to enable the development and manufacture of solid dose products containing drugs with OELs down to 0.01 µg/m3. The facility offers solid dose solutions for film coated tablets and multi-API capsules. Multiple levels of containment, supported by ‘single pass’ air, remove the need for routine personal protective equipment. With batch flexibility from 1 to 120 kg, each client’s API will be subjected to a full potent molecule risk assessment prior to project initiation. Only those products meeting the acceptable criteria will be processed within the facility. Once accepted, the compound will be safely nurtured through its lifecycle by Penn’s expert team of scientists. After a rigorous evaluation process, Penn selected O’Hara perforated coaters for the film coating of tablets. Small batch sizes up to 10 kg will be manufactured utilising O’Hara’s LC-MX and an LC-III will be used to coat larger batch sizes. Each coater has
interchangeable pans to achieve a selection of batch sizes. Containment risk areas such as tablet loading, inprocess sampling (weight gain evaluation and appearance) and tablet unloading were identified and solutions engineered. The LC-MX utilises ILC Dover flexible isolator technology to transport uncoated tablets and maintain containment during processing. The tablets are loaded and, during coating, samples are extracted via a sample thief through a continuous liner using a heatseal-cut method. With the larger LC-III coater, a different method of loading, sampling and unloading is performed. The uncoated tablets will be housed in a containment bag after compression. The bag of tablet cores are docked onto a coupling, the valve opened and tablets transported via a tablet chute into the pan. Unloading occurs by means of a reverse baffle action in the coater and then tablets are transferred out through a chute into a continuous liner. Inprocess sampling is performed using the same reverse baffle action during which the drum rotates slowly in an anti-
width is controlled to ensure the maximum coating coverage onto the tablet bed. O’Hara Technologies (EU Office) +32 32 89 49 31 david.decker@oharatech.com www.oharatech.com Penn Pharmaceutical Services Ltd +44 1495 711 222 enquiries@pennpharm.com www.pennpharm.com
Coaters Deliver Improved Functionality and Outstanding Results
Control System Ensures Extremely Efficient Coating Process
Coating Systems International (CSI) recently installed a TechniCota 400 coating system, with a 60 inch drum, which uses indirect gas as its heating medium. The company has installed systems that include heat recovery equipment for many years but, by combining the heat recovery process with an exceptionally low cost heating medium and a clever control system, it has come up with an extremely efficient process. The control system is key to its success and a benefit is that the overall installation cost for the customer does not increase. CSI uses the heat recovery process in all of its systems, even the completely mobile laboratory coater, the TechniCota LAB. It helps to minimise the increase in room temperature from the exhaust air when the mobile coating system is used.
clockwise direction to a specific position to unload 30 to 50 tablet cores into a continuous liner for in-process evaluation. The O’Hara coating system uses Schlick ABC-Technology (Anti-Bearding Technology) spray guns, which can provide a consistent and homogenous coat onto multiple shaped tablet cores. The coating solution is pumped through to the spray nozzles at high velocity, atomising the solution to provide a fine droplet particulate spray. The spray
CSI is part of Lark Technology Group, which possesses expertise in a wide variety of control applications for many industries from petrochemical, utilities and pharmaceuticals through to food and flour milling. Having in-house understanding of the tablet coating process allows CSI to meet customers’ exact requirements in terms of bespoke systems or modifications. A number of videos demonstrating CSI’s full scope of capabilities can be viewed on YouTube at www.youtube.com/user/coatingsystems. CSI +44 1359 245 192 david.graham@coatingsystems.co.uk www.coatingsystems.co.uk
The type of air system utilised by the Bohle coater provides significant process-related advantages, eliminating the risk of suspension spray drying. This reduces spray losses and improves coating structure. Tablets are handled with less mechanical stress thanks to the geometry of the pan and the mixing and conveying elements. Advantages of the Bohle coater include: • excellent mixing thanks to patented spirals; • careful product movement owing to low tablet bed thickness; • easy discharge by changing the rotating direction of the pan; • nozzles with ABC caps ensure long service life; • highly efficient suspension system thanks to the reduction of spraying losses; • faster processing because of a high number of nozzles and an efficient air system; • high batch size variability from 35 to 100% filling volume; • same pan geometries for easy scaleup; • and rapid and simple cleaning. The Bohle film coater is the high-end version of the Bohle coater. In addition to the aforementioned benefits, it offers the following processing features: • air-tight coater housing for high containment applications; • automatic nozzle adjustment, available on request;
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• adjustable inclination of the coater housing for extremely difficult applications; • pump head on each nozzle, available with optional nozzle suspension pressure measurement so blockage of nozzles can be immediately detected; • high pressure system on the inside of the pan for easy cleaning; • and computerised InTouch visualisation with extensive batch management tools and a broad range of features for preparing recipes. L.B. Bohle Maschinen + Verfahren GmbH +49 2524 9323 150 t.borgers@lbbohle.de www.lbbohle.de
Corporate News & Events
Pharmapack Europe 2013 Puts Patient at Heart of Innovation The 12th edition of Pharmapack Europe, on 13–14 February 2013, at Grande Halle de la Villette (Paris), will welcome over 3,000 visitors from all over the globe and around 280 international companies to the exhibition, which is dedicated to pharmaceutical packaging and drug delivery systems. This year, Pharmapack Europe will place the patient at the heart of the innovation process, encouraging participants to reflect on the driving role played by the patient in the development of drug delivery systems and pharmaceutical packaging. The aim of this is to uncover new areas for research and to promote convergence between the different sectors of the healthcare industry in order to create innovative solutions improving patient compliance with treatments and safety for patients and healthcare staff. All the while, changes in regulatory requirements, the need to optimise manufacturing processes, cost
reduction and sustainable development must be taken into account. At the conference — over the course of more than 40 semi-scientific presentations and a number of debates — a panel of international experts will offer a complete roundup of the current situation and new trends with regards to: • Patient Safety and Compliance Packaging; • Innovation in Parenteral Administration and Packaging Process; • Innovation for Pulmonary and Nasal Forms of Drug Delivery; • Targeted Drug Delivery via Convergent Technologies; • Sustainable Packaging and Materials. For the first time at Pharmapack Europe, a series of four technical workshops will take place alongside the conference programme. These meetings will enable participants to discuss in detail and receive expert guidance on current issues relating to:
Founder of Packaging Machines Firm Names Sons Chief Executive Officers
When Gerhard Schubert presented his first hot-melt box erecting and gluing machine to the public 46 years ago, his sons Gerald and Ralf were only two and five years old, respectively. It was the beginning of a success story in many ways. The box erecting and gluing machine was followed by a series of technical highlights, including the reportedly world’s first packaging robot, Schubert’s own packaging machine control unit, the F44 picker line and the TLM top-loading packaging machine for installation on an assembly line. This trend has continued up to the TLM transmodule, claimed to be the world’s first transport robot. The characteristics of its founder have made Gerhard Schubert GmbH a recognised global market leader in its field, resulting in a group of companies with more than 900 employees worldwide. Gerhard Schubert can now be especially proud of another achievement. His sons have been active within the company for more than 20
competition, the Pharmapack Awards jury now includes representatives of patient associations, doctors and wholesale distributors. Pharmapack Europe/ UBM Canon +33 1 77 48 10 04 pharmapack-info@ubm.com www.pharmapack.fr
Modular Cleanrooms Specialist Celebrates 10 Years in Business
years and he has now appointed them Chief Executive Officers. Gerald Schubert, 48, is a father of two children with a degree in mechanical engineering. He headed up the Schubert subsidiary IPS (International Packaging Systems) before assuming the role of Schubert Sales Division Manager. Ralf Schubert, 51, a father of three children, graduated in computer sciences and leads the Technical Office and Assembly Division. This proven management team is completed by Peter Gabriel (Dipl. oec. univ.) as Commercial Director and Peter Schneider (Dipl.-Ing./FH) as the head of the Materials Management Division. Gerhard Schubert will retain his overall management role and continue to devote himself to the Marketing Department. Gerhard Schubert GmbH +49 7951 400 0 info@gerhard-schubert.de www.gerhard-schubert.com
• Drugs and Isothermal Packaging: is it better to travel alone or in bad company? (Workshop A); • Serialisation: Track & Trace (Workshop B); • Medical Packaging Sterilisation & Validation (Workshop C); • Innovative Combination Products: Challenges and Approvals, EU-US (Workshop D). The Pharmapack Awards 2013 Ceremony, one of the highlights of the event, will give recognition to drugs, medical devices, healthcare products and veterinary drugs launched on the market between November 2011 and December 2012. In connection with the main theme of the 2013 edition and to pay greater attention to the benefits brought to the patient and user by the innovations submitted to the
Connect 2 Cleanrooms has announced its 10th year in business. Husband and wife team Joe and Lizzie Govier have grown the company from a start-up to a large player in the international cleanroom market. On 8 October 2002, Connect 2 Cleanrooms’ website first went live and demand was instant. On that first day, an enquiry came through and the first cleanroom project was won. After its immediate success, the company has shown no sign of slowing down. Turnover has been averaging a 25% growth year on year, which MD Joe Govier attributes to a commitment to customer service: “The past 10 years have literally been an amazing journey, with our products and services reaching all continents. The dedication of the people around me, our customers who entrust us with the most demanding of quality needs and our army of long-term suppliers have been key to our success. “I would like to thank everyone who has joined me on the C2C journey for their contribution, commitment and faith. We can only wish that we will be as fortunate over the next 10 years.” The company was founded in 2002 to provide flexible and cost-effective modular cleanroom solutions for organisations that need to create a clean environment quickly and with little disruption to production. Over the past 10 years, the company has developed fully bespoke cleanroom solutions, offering a choice of construction options that have provided many organisations with leading-edge cleanroom facilities. The launch of its closed-loop control system in early 2010 meant that Connect 2 Cleanrooms could fervently hold its
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own against traditional-build cleanroom competitors. Connect 2 Cleanrooms also has its own consumables division, Cleanroomshop.com. What began as a shop for Connect 2 Cleanrooms’ clients to purchase cleanroom supplies now boasts a help desk team of cleanroom professionals along with a fully transactional, international website that provides clients with a seamless purchasing experience. The Connect 2 Cleanrooms team now consists of sales and customer service, marketing, engineering, quality, accounts and logistics departments. The team continues to grow as Connect 2 Cleanrooms grows market share both at home and internationally, through a combination of direct sales and a European distribution network in the Benelux region, Spain and Poland. Future plans for the company include an imminent office move in late 2012 to a new location in Lancaster to accommodate a growing workforce. Increased warehouse facilities of over 1,300m2 will benefit stock management and cleanroom manufacture. Connect 2 Cleanrooms Ltd +44 15242 74170 marketing@connect2cleanrooms.com www.connect2cleanrooms.com / www.cleanroomshop.com
LABORATORY PRODUCTS & EQUIPMENT
Free Video Series Explores Benefits of Crystallisation Mettler-Toledo has released a series of four informative videos on crystallisation that explore how its technology advances the understanding, optimising and transferring of crystallisation processes for improved yield, purity and cycle times, ultimately saving researchers and manufacturers both time and money. Each brief video helps prospective users visualise the benefits of using PAT to improve crystallisation for enhanced control of critical process parameters. This enhanced control helps users improve yield, increase purity and shorten cycle times for faster process scaling and lowered manufacturing costs. The first video, ‘Understand Your Crystallization Process’, explores the use of PVM, a particle vision and measurement tool, to identify solvent and seeding parameters to produce desired crystal morphology. The second video, ‘Transfer Your
Crystallization Process’, shows how FBRM helps pharmaceutical and chemical engineers eliminate batch failure through thorough description of batch processing to enhance the scaling of experiments. In video three, ‘Optimizing Your Crystallisation Process’, two real-world examples reveal how combining both PVM and FBRM helped researchers in academia and manufacturing produce repeatable crystallisation with faster cycle times and improved yield. Video four, ‘The Crystallization Workstation’, shows how a robust combination of PAT technologies, including PVM, FBRM and ReactIR, can powerfully characterise crystallisation processes inline, resulting in fewer experiments, easier scaling and reduced costs. Free crystallisation white papers and on-demand webinars are also available. To view one or all of these free crystallisation videos or to access other
informative, on-demand crystallisation materials, please visit www.mt.com/crystallization. Mettler-Toledo AutoChem, Inc. +1 410 910 8486 patricia.hicks@mt.com www.mt.com
Lab Filter Dryer Now Available with Contained Options Powder Systems Ltd’s (PSL’s) Glass Filter Dryer (GFD) is a smaller version of a production filter dryer, allowing easy laboratory-scale filtration and drying with the same reliability and benefits as full size agitated nutsche filter dryers. This small-scale filter dryer is suitable for any laboratory requirements and is available in three filtration area sizes: MINI LAB (0.002 m2 – 0.5 l), LAB (0.01 m2 – 2 l) and MAXI LAB (0.05 m2 – 10 l). Its technology supersedes dated methods such as Buchner filtration, providing ergonomic and efficient drying. The GFD works on a vacuum and has a heated jacket for drying. To achieve a quicker drying time whilst maintaining a homogeneous product, the GFD has an adjustable agitator running both clockwise and anti-clockwise for smoothing the cake. The PSL removable filtration basket allows for total product collection, without having to dig the cake out of the vessel. PSL launched the GFD two years ago and has continually improved its features. The new generation of GFDs
benefit from new design features, including a control/drive with RPM reading, O-ring groove in the glass body to ease fitting of the basket and a mechanical agitator height adjustment system. The latter allows for adjusting without effort of the agitator height in the slurry or cake in an accurate and repeatable manner, thanks to the scale, by simply turning the hand wheel. The FilterBox is a new technology consisting of a GFD being completely integrated within a PSL isolator, providing high containment when handling highly potent APIs and other highly active or cytotoxic compounds. It achieves containment to nanogramme levels, protecting both the product and the operator during operations, including charging, sampling, filtration, drying and discharging. The GFD FilterBox is an acrylic glovebox surrounding PSL’s MINI LAB or LAB Glass Filter Dryer. Larger options include the MAXI LAB GFD, which can be incorporated within a full-scale isolator in stainless steel for kilo laboratory or pilot plant applications.
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MINI LAB GFD with removable filtration basket. PSL +44 151 448 7700 www.powdersystems.com info@powdersystems.com
LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Collaborative Study Uses Light Scattering Techniques to Support Formulation Development In a recently published article, UK researchers from Novozymes Biopharma in Nottingham and Malvern Instruments in Malvern describe collaborative work using light scattering techniques to demonstrate the short- and long-term stability of the recombinant human albumins Albucult and Recombumin. These rAlbumins have been developed and optimised to deliver a safe, stable and regulatory-compliant product for therapeutic formulations. The teams applied the resolving and detection capabilities of size exclusion chromatography light scattering (SECLS) and dynamic light scattering (DLS) offered by Malvern systems to monitor the stability of these Novozymes products. The article ‘Tools for evaluating the stability of human recombinant albumins used in human therapeutics’ can be accessed at www.malvern.com/formulationdevelopment. Novozymes Biopharma develops and
manufactures high quality, animal-free and regulatory-compliant recombinant ingredients and technologies to support the development of pharmaceutical products. Understanding and manipulating protein behaviour is a central element of the associated research and a core company expertise. The work described here focused on the use of light scattering techniques to test protein stability under a variety of conditions. Malvern’s Zetasizer APS, Zetasizer Nano ZS and Viscotek TDAmax SEC-LS were used in studies that examined the effects of pH, temperature and concentration on oligomerisation and aggregation behaviours. The results can be used to demonstrate short-term stability and predict shelflife. Both SEC-LS and DLS were found to be useful for the rigorous testing required to understand and confirm protein stability under various conditions. SEC-LS allows detailed
characterisation of the type of oligomers or aggregates present in samples of therapeutic proteins. DLS provides a rapid measurement that allows rapid comparison of a number of sample conditions and to indicate the presence of large aggregates and small oligomers or aggregates. Malvern offers a growing range of systems for protein characterisation. The Zetasizer Nano is one of the most widely applied systems for measuring particle size and molecular size using dynamic light scattering and protein mobility (zeta potential) by electrophoretic light scattering, while the Zetasizer APS offers robust, simple to operate, dynamic and static light scattering and automates the measurement of samples in industry standard 96- or 384-well plates. The
Viscotek TDAmax is a complete, research grade, temperature controlled, multi-detector SEC system, suitable for the molecular weight and molecular size determination of proteins and other macromolecules. Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com
Reactors with Exceptional Mixing Performance Offer Simpler Scale-Up Asynt, in conjunction with Innovative Physical Organic Solutions (IPOS), a research group based within the Department of Chemical and Biological Sciences at the University of Huddersfield, UK, have cooperated over the last two years to develop a new generation of chemical reactor. Asynt is a supplier of products, consumables and services for chemists in industry and academia. The primary focus of IPOS is delivering external customer contracts. The group consists of a team of highly skilled, industrially experienced chemists specialising in the application of physical organic chemistry towards efficient optimisation of chemical processes. By better understanding and improving the flow and thermal dynamics of the Asynt ReactoMate system, the cooperation is now able to produce reactors that offer exceptional mixing performance. The benefits of this
development for chemists will be simpler process development and scale-up, faster reactions, better reproducibility and improved selectivity. Martyn Fordham, Managing Director of Asynt, commented: “We were pleased to cooperate with IPOS on this development because of their considerable expertise in chemical engineering and experience in advising chemists on scaling reactions that were often rate limited by poor mixing.” He added: “At the start of our cooperation, Asynt ReactoMate reaction systems, as with all of our competitors, did not offer optimised mixing. However, today we can offer customers the option of using ReactoMate to scale chemistries with well designed mixing by IPOS. This consideration has proven especially important when reaction chemistries are exothermic for example.” Dr. Nicholas Powles, a Senior Research Fellow at IPOS, commented: “The
complexities associated with optimising and scaling up laboratory reactions are of critical importance in industrial process development. Our co-operation with Asynt will help commercialise the essential tools and know-how for efficient process understanding and optimisation.”
Asynt Ltd +44 1638 781709 sales@asynt.com www.asynt.com / wwwold.hud.ac.uk/ipos
Data Sheet Describes FibreOptic Coupled Spectroscopic Cuvette Sampler Axiom Analytical has announced the availability of a new data sheet covering its FCV-150 fibre-optic coupled cuvette sampling system. The FCV-150 is compatible with FTIR and dispersive spectrometers operating in the NIR and UVVisible spectral regions. It provides precise temperature control while accommodating sample containing cuvettes with a wide range of optical pathlengths. The FCV-150 features sampling region accommodating cuvettes with path-lengths from 1 to 50 mm as well as a preheating zone. This combination provides for rapid interchange of up to 15 samples. The use of fibre-optic coupling facilitates sample analysis in a fume hood or in other locations separated from the spectroscopic analyser. The company reports that the FCV-150 is being applied in QC and service laboratories as well as chemical and pharmaceutical development and modelling for PAT applications. Axiom Analytical, Inc. +1 949 757 9300 www.goaxiom.com EPM 18
LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Chip-Based MS System Eliminates Guesswork from Process Development Microsaic Systems is reportedly the only company to have commercialised mass spectrometry technology on a chip. The company’s patented MS technologies — spraychip, vac-chip and ionchip — allow for the production of MS detectors that are smaller, lighter, consume less energy, are easier to maintain and cheaper to run than conventional systems. The chips can be interchanged rapidly by the user, enabling greater adaptability and speed. Ninety per cent smaller than conventional mass spectrometers, the 3500 MiD is a versatile, portable solution for bench chemists in medicinal chemistry laboratories. Developed in collaboration with three major pharmaceutical companies, it is an extremely robust system that is simple and intuitive to use. The system integrates with existing HPLC equipment, with no extra footprint or infrastructure requirements. Other
separation methods, such as Prep LC, Flash LC and SFC, can also be combined with the 3500 MiD to offer mass directed purification. According to the company, the product represents a step change in the footprint of mass spectrometry. Its small size means it can be easily incorporated within a stack or cluster of instruments on a particular chemist’s workspace. Most outstanding is the fact that the product is fully self-contained. The vacuum chamber and pump, as well as the electronics, are included in a whole system that can be used by connecting a standard screen, keyboard and mouse. The MiD 3500 is also small enough for fume-hood applications and on-line analysis. Monitoring a batch reaction as it progresses gives invaluable information about the process, providing the chemist with the power to act if the reaction is not going as
planned. Reaction optimisation can be performed in a fraction of the time, taking out the guesswork of process development.
Microsaic Systems plc +44 1483 751577 info@microsaic.com www.microsaic.com
University Scientists Benefit from High Throughput Micro-Volume Protein Analysis
Dutch Biotech Company Opts for Fragment Library Recommended by Renowned Expert
Avacta Analytical’s Optim 1000 — a high throughput, micro-volume protein analysis and characterisation system — is proving a valuable asset to scientists at the Macromolecule and Vaccine Stabilization Center (MVSC), University of Kansas, US. Professor C. Russell Middaugh explained: “Conventional analytical techniques used in preformulation, stability and formulation studies rely on methods that extrapolate partial data on slow and labour-intensive instrumentation, making them incompatible with high throughput measurements and tight development timelines. We have developed a faster and more comprehensive approach, which depends on the measurement of all potential variables. The results are then processed mathematically using specially developed software and are represented visually using empirical phase diagrams. “Ideally, a replicate series of results is acquired for each parameter and, although a variety of instruments can be used for individual measurements, this type of equipment tends to rely on relatively time-consuming processes and can generally handle only low throughputs. Sample volume is also an issue since many conventional techniques require large amounts of the target molecule.
Thermo Fisher Scientific has been selected to supply compounds from its Maybridge Ro3 2500 Diversity Fragment Library to a leading fragmentbased drug discovery firm based in the Netherlands. ZoBio, a spin-off of Leiden University, focuses on the development and commercialisation of biophysical technologies that enable new approaches to drug development and selected the Maybridge fragment library on the recommendation of Dr. Edward Zartler, CEO of Quantum Tessera Consulting LLC. Dr. Zartler was consulted to identify and purchase the most suitable targeted screening library for ZoBio’s structure-based discovery needs, selecting the Thermo Fisher library for its broad range of pharmacophores. With more than 10 years of experience in the pharmaceutical industry, Dr. Zartler is an internationally recognised expert in fragment-based drug discovery and editor of the book ‘Fragment Based Drug Discovery: A Practical Approach’. He evaluated several options before selecting the Maybridge collection. ZoBio has begun using the Maybridge library to design its own compound collection targeted to an epigenetic drug target. The collection will enable
“The Optim 1000 provides rapid, multi-modal analysis of ultra-low sample volumes at high throughputs, precisely the kind of replicate measurements we need to generate data in a timely manner. Combining multiple technologies in a single instrument is already making in-roads into preformulation and formulation studies and this approach is proving a real asset to researchers involved in the drug development process.” Avacta Analytical +44 844 414 0452 info@avacta.com www.avactaanalytical.com/optim-1000
Flow Chemistry System Reveals Another Dimension in Drug Discovery The Discovery Chemistry Department at Gedeon Richter in Budapest, Hungary, has invested in an Asia flow chemistry system from Syrris to aid researchers involved in the design and synthesis of original CNS drugs. Research scientist Dr. György Túrós explained: “In discovery chemistry research, we need to perform a lot of very interesting and complex chemical syntheses and, until now, have relied on classical batch chemistry methods. “We purchased an Asia flow chemistry reactor in June and are now reaping the benefits of using flow chemistry techniques. The system has extended the range of chemistries available to us, allowing us to work at much higher pressures and temperatures — sometimes above a solvent’s boiling point — to create completely new heterocyclic scaffolds. We
can combine the Asia modules in a variety of different ways to meet changing needs and will also be able to add additional modules at a later date if required. This was an important consideration and one of the main reasons for choosing Asia. Syrris has been very supportive, giving us some valuable ideas and flow chemistry tips during our training and we can now do chemistry that was absolutely impossible before. In my opinion, Syrris is as innovative in the synthetic chemistry arena as Google or Apple in the informatics field.” Syrris Ltd +44 1763 242 555 info@syrris.com www.syrris.com EPM 20
ZoBio’s customers to pursue and expedite fragment-based drug delivery. “The entire Maybridge 2500 collection is Rule of Three (Ro3)-compliant and exceptionally well-curated with greater than 95% purity assurance and guaranteed solubility of 1 mM in aqueous phosphate buffer solution,” said Dr. Zartler. “ZoBio assembled its 250 fragment library by virtually screening against a pharmacophore model. It was easy to triage and accept molecules because Maybridge has already done a tremendous job of removing chemically suspect molecules. The breadth of chemical diversity and the depth of compounds to choose from allowed them to rapidly put together a robust, diverse and structure activity relationship-compliant library.” Maybridge compounds are ideal for development beyond the initial screening assay. Of the approximately 400,000 pharmacophores in the World Drug Index, 87% are expressed by the Maybridge Ro3 2500 diversity fragment library. Thermo Fisher Scientific Inc. +1 508 482 7013 marcia.goff@thermofisher.com www.thermofisher.com / www.maybridge.com
LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Development of Thermal Cycler Range Supports Successful Sales There has been high demand for the Techne Prime thermal cycler range since its introduction at ACHEMA 2012. With sales of Prime and 3Prime continuing to
increase, Techne has added to the online materials available and improved the already exceptional warranty it offers, ensuring that users get the high levels of support and quality for which the brand is known. Further software enhancements are in development. Techne’s website has been updated to include all the latest technical information, software downloads, user guides, declarations of conformity, quality certificate, licensing certificate and gradient upgrade procedure. Instructional videos will soon be available to help support new users.
Bibby Scientific Ltd +44 1785 812121 info@bibby-scientific.com www.bibby-scientific.com / www.techne.com
handbook provides detailed specifications and GHS-compliant hazard symbols for all products along with grade, application, physical, chemical and transportation information. With many different product grades available, there are products to suit every analytical and life science application. Analytical reagents and solvents are produced in an ISO 9001:2000- and ISO 14001-compliant manufacturing site. All products feature environmentally friendly packaging that is designed for quality, safety and convenience. Customers can order the Fisher Chemical and Fisher BioReagents Laboratory Reagents Handbook from www.acros.com/labreagentshandbook/ default.htm.
Eppendorf has introduced the electronic pipette Eppendorf Xplorer plus. The intuitive operating concept and ergonomic display of the Xplorer is outstanding in terms of simplicity, precision and reproducibility. The Eppendorf Xplorer is specially designed for users working with complex or long pipetting series requiring exact setting of parameters, maximum reproducibility and low operating force. With the release of the Xplorer plus, there are now additional intelligent applications, adjustable fixed-volumes and individual programming tasks are performed much faster and easier. The Xplorer plus also includes a history function that automatically saves the last parameters for faster handling. A password can be entered to guarantee a high degree of protection for personal programming and settings. These features mean no more delays owing to complicated programming or inflexible processes. Instead, get precisely adjustable parameters, maximum reproducible results, fatigue-free work and consistent, full control over the pipetting processes. Eppendorf UK Ltd +44 1438 735 888 sales@eppendorf.co.uk www.eppendorf.com/xplorer
Thermo Fisher Scientific Inc. +1 508 482 7013 marcia.goff@thermofisher.com www.thermofisher.com / www.acros.com
Fully Automated Microwave Peptide Synthesiser Meets Smalland Large-Scale Research Requirements Biotage introduced a new synthesis platform for peptide researchers at the 2012 European Peptide Symposium in Athens, Greece. The Biotage Initiator+ Alstra is a fully automated, single channel, programmable microwave peptide synthesiser and is the latest addition to Biotage’s growing family of peptide synthesis platforms. The Initiator+ Alstra is an ideal tool for peptide chemists synthesising peptides, peptoids, PNA and peptidomimetics, including extremely difficult modifications. The system’s inherent flexibility for reagent setup makes it a highly effective platform for both smalland large-scale synthesis from 5 µmol to 2 mmol. With a working volume from as low as 0.6 ml, the Initiator+ Alstra is perfectly suited for small-scale microwave peptide synthesis, especially when the use of expensive building blocks is required, e.g., PNA. The system’s robotic liquid handler and precise digital syringe pumps reduce reagent and solvent consumption, thus reducing cost and minimising waste. The Initiator+ Alstra is programmable
touchscreens across the whole range make the cyclers easy and enjoyable to use. The Prime thermal cycler range combines ease-of-use with the flexibility to upgrade and meet future requirements in a cost-effective way. High performance, exceptional value and reliability are core points of the design philosophy across the range and come together to provide an outstanding user experience.
Electronic Pipette Offers Excellent Reproducibility
Easy-to-Use Handbook Provides One-Stop Access to Comprehensive Range of Reagents and Solvents Thermo Fisher Scientific has launched its new Fisher Chemical and Fisher BioReagents Laboratory Reagents Handbook, an essential, easy-to-use reference guide for one-stop access to its comprehensive laboratory reagent ranges. The Handbook features 250 new products, including an extended range of Optima liquid chromatography/mass spectrometry (LC/MS) solvents and high-purity acids for trace elemental analysis, microbiology media and modifying enzymes. In addition, the Handbook includes more than 4400 Fisher Chemical products and solutions dedicated to analytical applications and more than 1000 Fisher BioReagents products for molecular biology research, biochemistry and cellular biology. Designed to be easy to navigate, the Fisher Chemical and Fisher BioReagents Laboratory Reagents Handbook allows users to quickly access product information by application or product name. The
All thermal cycling applications are addressed within the Prime range, ranging from personal cyclers for occasional use to full-size instruments for high-throughput laboratories. High reliability is guaranteed, with a four-year warranty that has recently been improved to make the high-throughput cycle number of interchangeable blocks unlimited for the whole Prime thermal cycler range. The Techne Prime instruments also provide a new, improved and simplified gradient upgrade facility, ensuring flexibility and allowing users to update existing machines rather than purchasing another when their needs change. Intuitive interface and colour
via a large 10” touchscreen with drag and drop functionality for optimising pre-installed or user-defined methods. A built-in wizard makes programming a synthesis sequence effortless and a calculation table, which is generated, provides the quantities of reagents required, allowing the user to very quickly go from an idea to execution. “Initiator+ Alstra is an extremely simple to use workhorse that fills an important gap in the toolbox of the peptide researcher. Its state-of-the-art interface, simplicity of operation, speed, size and price are all optimised to match the increasing demands that peptide chemists are under pressure to meet today,” said Dr. Amit Mehrotra, Peptide Product Manager at Biotage. “This product is the result of customer input and demands and we are very excited to now be putting it into their hands.” Biotage AB +46 18 56 57 10 info@biotage.com www.biotage.com EPM 21
SHOWCASE IT PAT Software Update Accommodates Lab Research to Global Production With the release of synTQ V4.0, process industries — such as life science, chemical and food, plus oil and gas — can use one proven software platform to develop, deploy and manage PAT from the research laboratory to their global production networks. synTQ V4.0 is the latest major update of the PAT implementation management software from Optimal Industrial Automation. synTQ is in use today by six out of the top twelve global pharmaceutical companies and by major industry regulators. In its effort to drive up quality and reduce manufacturing costs, the global pharmaceutical industry is moving away from a reliance on end-of-line and endof-process testing and inspection and towards on-line and in-line analysis and closed loop control through the use of PAT. synTQ supports this transformation by providing a bridge between the sophisticated instrumentation used to monitor manufacturing processes and the advanced multivariate analysis and modelling systems needed to interpret that data. At the same time, synTQ records all of the measured and derived data, can feed the derived data into the
control system of choice and does all of this in compliance with regulatory requirements. Its new enterprise system architecture allows companies to manage all of their data from one central point, thus greatly simplifying model management and enabling the sharing of models between different synTQ nodes anywhere in the world. Naturally, data archiving is also very much simplified. Such extended management and control capabilities are becoming increasingly critical as life science clients scale up and roll out their PAT systems. Using synTQ 4.0, for example, companies can ensure that products manufactured at multiple sites across the globe all use the most up-todate models and controls. The new capabilities are equally important as the use of external suppliers grows, allowing clients to integrate process monitoring and control at their contract manufacturing partners directly with their own quality control and recording systems. The new synTQ release also includes significant enhancements for process users. Enhanced data visualisation modules, including web views, further
improve the system’s speed and usability, helping companies gather data and build, test and validate models faster and with more confidence. These improvements, combined with synTQ’s real-time analysis and control capabilities, give users a seamless route through PAT development from initial
laboratory tests and model design and validation and all the way to high-volume global production. Optimal Industrial Automation Ltd +44 1454 333 222 mgadsby@optimal-ltd.co.uk www.optimal-ltd.co.uk
Podcast Highlights LIMS Specialist’s Commitment to Long-Term Customer Support A new podcast available on Two Fold Software’s website highlights the company’s dedication to providing the best possible service to its customers. For anyone considering a LIMS, the podcast allows them to get to know the company and its values. This dynamic way of interacting with potential clients helps potential purchasers to understand how Qualoupe software, a fully featured LIMS System developed in-house by Two Fold Software, may suit their individual needs. Qualoupe allows business to grow through increased efficiencies by providing an integrated data
management system capable of supporting workflows and data tracking. It supports QA, R&D and manufacturing applications across a range of sectors. All products from Two Fold Software are backed with support, advice, consultancy and comprehensive training. UK-based Two Fold Software is dedicated to providing affordable, fit for service, business software to companies of all sizes. Their distinctive rental scheme distributes costs and makes the software available even to smaller companies. “We’re very much centred on trying to
develop real business partnerships with our clients,” said Clive Collier, Managing Director of Two Fold Software. “By providing good, constructive help to those companies, they can get the most out of the software. We aim to create a level of respect between us and our clients and for them to see long-term benefits from that relationship.” To find out more, download the podcast at http://bit.ly/twofold_podcast. Two Fold Software Ltd +44 844 208598 info@twofold-software.com www.twofold-software.com
Scientific Community to Benefit from Open-Source Version of Leading Pharma Company’s Chemistry ELN GGA Software Services has released version 1.0 of Indigo ELN, an opensource version of the chemistry electronic laboratory notebook that was developed by one of the world’s largest pharmaceutical companies. GGA received the exclusive licence from this global pharmaceutical company to create and distribute the open-source version and it has been working to modify the pharmaceutical company’s internal chemistry ELN for distribution as an open-source application. The system is now publically available for downloading at GGA’s website under the open-source GNU General Public License, version 3. “Indigo ELN represents a leading,
cost-effective alternative to commercial ELN products. Users can upgrade their existing ELN with a proven and tested open-source platform and they can do it at no charge,” said Richard Golob, GGA’s President and Chief Executive Officer. Benefitting from the considerable investment by this global pharmaceutical company in its internal chemistry ELN, Indigo ELN provides scientists with a proven way to create, store, retrieve and share electronic records of chemistry information in ways that meet all legal, regulatory, technical and scientific requirements. It allows scientists to prepare, plan and analyse experiments, access relevant
information and develop new methods in the areas of synthetic chemistry, analytical chemistry and process chemistry. Users will be able to perform a number of functions, including creating and setting up singleton experiments, running experiments and recording results, automatically registering and submitting batches, attaching related documents and printing reports. In addition to this core package, users can integrate Indigo ELN with existing or new customer services, such as compound registration, structure verification and analytical information services as well as chemistry logistics systems.
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Furthermore, users can integrate Indigo ELN with GGA’s open source offerings, such as its Bingo molecular search engine for Oracle database, its Ketcher chemistry drawing tool and its Indigo cheminformatics engine. GGA is offering broad support for Indigo ELN, including installation and configuration services, integration of the core Indigo ELN system into the user environment and with other services, creation of custom functionality and support and maintenance. GGA Software Services LLC +1 617 491 5100 jmartin@ggasoftware.com www.ggasoftware.com
SHOWCASE FREEZE DRYING Temperature Controlled Microscopy Specialist and Freeze Drying Solutions Provider Celebrate 10-Year Partnership Biopharma Technology Ltd (BTL) develops freeze drying solutions for multiple materials in the world of pharmaceuticals. The early days of the company saw homemade instrumentation based on ideas originating at Porton Down. However, in 2001, Dr. Kevin Ward, Director of Research at BTL, came across Linkam Scientific Instruments and its range of temperature controlled stages. Freeze drying had often been conducted as a hit and miss process, without clear knowledge of the critical temperatures needed to produce the best product. The ability to provide accurate thermal characterisation, right down to -196˚C, took the guesswork out of the process quickly and simply. The companies went on to develop a number of instruments, the latest being the Lyostat3 freeze drying microscope. Dr. Ward, understanding that a scientific approach was critical to the development of the process, has gone on to perform contract work looking at more than 700 samples from companies worldwide. Being able to optimise the freeze drying temperature greatly aids the formulation in a vast family of biotechnology, pharmaceutical,
diagnostic and agrochemical applications. The combination of BTL’s applications knowledge and Linkam’s instrumentation expertise brings a real added-value product to the freeze drying market place. A typical experiment will look at the temperature at which a product undergoes collapse as this is the single most important characteristic for almost all freeze drying formulations. The Lyostat3 system uses polarised light microscopy to capture images of the sample’s structural changes as temperature increases, information that is vital for successful freeze drying. This data is invaluable when developing a freeze drying cycle from scratch or in helping to identify the small adaptations in a freeze drying cycle that can transform the process operating costs. The advantages of a tailored production process are obvious; research has shown that a 1˚C increase in product temperature can result in as much as a 13% increase in primary drying rate, demonstrating that thermal accuracy can transform process operating efficiency and costs. The collaboration has provided BTL with quality pictures that illustrate the
Microscope system utilises Linkam’s optical imaging station and temperature controlled stage to characterise the freeze drying process. process at varying precisely controlled temperatures and pressures. For Linkam, the benefit is being among those companies at the forefront of an exciting and growing market. Freeze drying used to be solely the domain of big pharmaceutical companies but now the smaller, specialty businesses in the fields, such as biotherapeutics and
biopharmaceutics, are using the BTL technology to study bigger, more complex molecules. Linkam Scientific Instruments Ltd +44 1737 363 476 info@linkam.co.uk www.linkam.co.uk
Freeze Drying Microscope Upgrade Enables More Detailed Analysis of Crystal Structures
Article Demonstrates How Controlled Nucleation Temperature Impacts Product Resistance
Freeze drying microscopy is an established technique for identifying critical formulation parameters. Historically, this included just collapse temperature (Tc) and eutectic melting temperature (Teu) but Biopharma Technology Ltd’s latest generation microscope Lyostat also enables identification of crystallisation phenomena, the potential for skin/crust formation and the effects of annealing on ice crystal growth and solute structure. This information is vital for successful formulation and process development. The latest upgrade is the analyser collar and tint plate assembly. This is designed to fit onto the imaging station and enables users to view their samples with polarised light and a first-order red filter to enable more in-depth analysis of the crystal structures with the frozen samples. With the false colour applied to the analysis, it is now even easier to determine the critical temperature of samples. Analysis without the polarising setup can also be undertaken whenever required. The analyser collar and tint plate assembly is used in conjunction with the optical imaging station. In standard upright microscopes, the objective lens is very close to the sample, making loading and unloading awkward. With the imaging station, the viewing optics
SP Scientific has written a technical article that describes research undertaken to understand the impact of controlled nucleation temperature on freeze drying product resistance. The researchers demonstrate how SMART Freeze Dryer technology is able to simplify and accelerate the determination of product resistance during controlled nucleation freeze drying experiments. SMART Freeze Dryer technology is a reportedly unique control software tool, proven to enable development scientists to accelerate and streamline the arduous task of developing and optimising freeze drying cycles. According to the company, based upon unique control algorithms developed by some of the world’s leading lyophilisation experts, SMART Freeze Dryer technology enhances freeze drying cycle development in several important ways. Traditional cycle development relies on the experience and intuition of the development scientist along with a trial and error approach. This often requires weeks of development time and multiple test cycles can consume scarce and valuable active ingredients. SMART technology enables the developer to generate the right cycle on the first attempt. The authors of the technical article demonstrate how SMART Freeze Dryer technology is able, in conjunction with
are mounted in a hinged arm that tilts out of the way, giving unrestricted access to the sample. The assembly can be retrofitted to any existing system with an imaging station and will be offered as standard with all new Lyostat3+ systems. Biopharma Process Systems Ltd +44 1962 841092 btl@biopharma.co.uk www.biopharma.co.uk
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ControLyo On-Demand Nucleation technology, to instantly link product related properties such as product resistance to important process performance attributes. ControLyo and SMART technologies are exclusively available on the SP Scientific Lyostar 3 R&D freeze dryer. A copy of the technical article is available from the SP Scientific website. SP Scientific Inc. +1 845 255 5000 shireen.scott@spscientific.com www.spscientific.com
Corporate News
Life Science Products and Applications Support Company Celebrates Opening of UK Headquarters Eppendorf has celebrated the opening of its new UK headquarters in Stevenage together with 60 guests from all walks of science and industry. Guest of honour Dr. Dirk Ehlers, President & CEO of Eppendorf AG, performed the official opening of Eppendorf House, a high-grade, energyefficient facility on the Arlington Business Park in Stevenage. Before unveiling a commemorative plaque, Dr. Ehlers spoke about the company’s origins, long history and absolute commitment to scientists in the UK. The grand opening event was hosted by Albrecht Wiener, Managing Director of Eppendorf UK, and featured an address given by Dr. Simon Boulton from Cancer Research UK, winner of the 2008 Eppendorf Young Investigator Award. After the official ceremony, guests were treated to a tour of the new building and a buffet lunch with opportunities to meet all the Eppendorf UK team. “The purchase and custom-fitting out of the UK headquarters represents a major investment for Eppendorf and
really underpins our belief in and commitment to the quality and dynamism of science in the UK,” said Dr. Ehlers. “The move from previous premises in St Albans and Cambridge is the culmination of several years’ work including the successful integration in 2011 of Eppendorf UK and New Brunswick Scientific UK, following Eppendorf AG’s acquisition of New Brunswick in 2007. We have now brought the teams from both of the UK organisations together under one roof in a conveniently located, state-of-the-art facility that provides everything necessary to deliver expert customer service and support across the UK and Ireland.” At around 883 m2, the two floors of Eppendorf House more than double the company’s accommodation. The new HQ features a fully equipped demonstration area for both Eppendorf and New Brunswick products and a comprehensive on-site service and repair department as well as an applications laboratory, training, conference and meeting areas.
Wiener commented: “In 2013, Eppendorf will celebrate 15 years of direct operation in the UK and despite the current challenging global economic conditions, sales of both the Eppendorf and New Brunswick brands continue to increase. We work hard to maintain our reputation for high quality products and excellent customer support and the new
facilities and extra space we now have will allow us to build this further. I very much look forward to welcoming many more visitors to our new home.” Eppendorf UK Ltd +44 1438 735 888 sales@eppendorf.co.uk www.eppendorf.co.uk
Swiss Liquid Handling Specialist Elects Distributor for UK and Ireland
Materials Characterisation Company to Supply Award-Winning Particle Metrology System in Europe and Asia
Metrohm UK is now an official distributor of the Socorex range of liquid handling instruments, including Acura and Calibra electronic and manual micropipettes, to the UK and Ireland. Similar to Metrohm AG, Socorex is an internationally well-known and trusted Switzerlandbased company that manufactures a wide variety of high precision instruments used for reliably measuring, dosing, transferring, dispensing and injecting liquids in a large number of laboratory applications and supplying to research and scientific laboratories globally. “Becoming a Socorex distributor is an exciting step for Metrohm UK and Ireland. Increasing our portfolio of products enables us to increase our offering to our existing customer base,” said Andy Matthews, Managing Director, Metrohm UK and Ireland. Calibration and Service Support will be provided from Metrohms’ Head Office based in Runcorn, Cheshire, where a Product Specialist has been newly appointed to integrate the Socorex product range.
Malvern Instruments has signed an exclusive distribution agreement with Affinity Biosensors LLC, California, US, which will extend the range of solutions that Malvern offers to the biopharmaceutical sector. The distribution agreement covers all geographies outside the US and Canada. Under the terms of the agreement, Malvern will distribute the Archimedes Particle Metrology system, developed and manufactured by Affinity Biosensors, through its subsidiaries in Europe and Asia. Malvern will establish a comarketing arrangement with Affinity Biosensors in North America. Archimedes, which won the Pittcon Editors Gold Award in 2010 and an R&D100 Award in 2010, employs a patented technology co-invented by the Massachusetts Institute of Technology (MIT) and Affinity Biosensors. Using the technique of Resonant Mass Measurement (RMM), Archimedes detects and counts particles and determines their mass and size with high resolution and accuracy in small sample volumes. A key area of application is the measurement of protein aggregation in biotherapeutic formulations, which provides critical information needed to speed development and improve drug safety and efficacy. Archimedes provides the technology to both count and characterise aggregates, making it
Metrohm UK Ltd +44 1928 579 600 socorex@metrohm.co.uk www.metrohm.co.uk
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invaluable to biopharmaceutical manufacturers and developers. Archimedes allows precise measurement of size and mass of particles with diameters down to 50 nm. Measurements are unaffected by optical or shape variations and gentle fluidics ensure that fragile aggregates are not disrupted. The instrument can measure high viscosity samples and consumes as little as 100 µl of precious protein formulation. Archimedes can accept particle concentrations up to 1 x 109 per ml, allowing direct study of undiluted high concentration formulations. Archimedes can also differentiate between protein aggregates and silicone oil droplets in an injectable biopharmaceutical using buoyant mass measurement, reportedly something that no other technology can do at the submicron size scale. Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com
INGREDIENTS & CONTRACT SERVICES
Catalent Applied Drug Delivery Institute Launches at AAPS
Catalent Pharma Solutions announced the launch of its Catalent Applied Drug Delivery Institute at the 2012 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition, Chicago, Illinois, US. The Catalent Applied Drug Delivery Institute aspires to promote innovation, knowledge-sharing and collaboration between industry leaders, academic experts, customers and regulators to enhance understanding of available, emerging and future drug delivery technologies and improve patient care. “The mission of the Catalent Applied Drug Delivery Institute is to bring better treatments to market by advancing the development and adoption of applied drug delivery technologies,” stated Kurt
Nielsen, Ph.D., Senior Vice President of Research and Development. “By harnessing the knowledge of some of the world’s leading experts in drug development, delivery and formulation, the Institute will cultivate leadership and excellence in drug development through education, training and innovation.” As part of its mission, the Catalent Applied Drug Delivery Institute will serve as a link between industry and academia by providing guidance, counsel and resources on major issues pertaining to drug development, delivery and formulation. The Institute will develop programmes that facilitate mutually beneficial collaborations, increase communication and shed light on regulatory issues affecting drug developers and researchers. It will also pursue a multi-tiered approach of seed funding, strategic counsel and educational programmes to advance the adoption of emerging technologies. There will be a series of Institute-led initiatives designed to enhance
understanding of drug delivery and inspire the next generation of science leaders. These initiatives, which will target both industry and academic audiences, will include: • Applied Drug Delivery Events and Training Programs for Industry; • Innovation and Research Collaborations with Universities and Technology Companies; • Catalent Applied Drug Delivery Institute Scientific Journal; • Science Leaders of Tomorrow University Partnership Programme; • Student Drug Delivery Guide; • Annual Drug Delivery Landscape Technology Survey; • Scientific Communications. For more information about the Catalent Applied Drug Delivery Institute, visit www.drugdeliveryinstitute.com. Catalent Pharma Solutions +1 732 537 6407 patricia.mcgee@catalent.com www.catalent.com
CMO Wins European Oursourcing Award for Successfully Integrating Three Sites Aesica has won the European Outsourcing award for ‘best acquisition’ following the successful acquisition and integration of three different UCB sites — at Monheim and Zwickau in Germany and Pianezza in Italy in 2011. The acquisition enabled both companies to concentrate on their growth areas and included a strategic partnership guaranteeing a secure pipeline of work and job security for staff. In the year since the facilities were acquired by Aesica, the company has been able to increase productivity across all sites and has delivered significant growth with the addition of 12 new clients.
The acquisition of the UCB sites follows the integration of R5 Pharmaceuticals in 2010 and has enabled a transformational stage in the company’s development, with sales growing over 37% in the last two years and turnover predicted to grow from $180 million in 2011 to $270 million by the end of the year. The remarkable success of these acquisitions has been down to the successful integration of new staff into the Aesica culture and the discipline in targeting sites that complement existing facilities and provide secure manufacturing contracts. A key feature of the integration programme was the
introduction of Aesica ambassadors across all three European sites that facilitated the transition process by identifying cultural gaps and opportunities where new business could be developed. Simon Clough, Managing Director of Formulated Products and a key figure in the successful integration process, added: “This award is the culmination of the team’s hard work over the last few years in helping deliver on the company vision to be the number one supplier of APIs and formulated products to the pharmaceutical industry. However, it’s not simply a case of identifying sites and doubling your capacity. What has enabled the smooth transfer of capabilities has been the workshops, site visits and integration programmes put in place to identify any issues and tackle sensitivities quickly and efficiently. Another landmark element of these deals was the strategic partnership entered into with UCB for guaranteed longterm supply agreements. This has provided UCB continuity of product and enabled Aesica to build up the sites’ capacity from a secure base.” Aesica Pharmaceuticals Ltd +44 191 218 1960 info@aesica-pharma.com www.aesica-pharma.com
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INGREDIENTS & CONTRACT SERVICES ROUNDUP Contract Manufacturer Announces Biologics Agreement for Australian Facility
Parenterals Specialist Works with Customers to Meet Manufacturing Challenges
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, has signed a biologics contract manufacturing agreement with Paranta Biosciences Ltd of Melbourne, Australia. The contract covers the process development and cGMP manufacture by DSM of Paranta’s lead recombinant human protein. This project represents an agreement for DSM with an Australian customer at its Brisbane facility. Paranta Biosciences is an early stage drug development company dedicated to developing and commercialising novel biotherapeutics based on recombinant human follistatin for the treatment of respiratory diseases. Alexander Wessels, CEO of DSM Pharmaceutical Products, stated: “Working with Paranta is an important milestone for DSM to support the local client base directly from our facility in Australia, expanding our presence in global regions. Our collaboration with Biopharmaceuticals Australia (BPA), the Queensland Government and the Australian Commonwealth Government is already bringing benefits to Australia by providing biopharmaceutical firms with local support and manufacturing expertise.” Ross Barrow, CEO of Paranta Biosciences, stated: “Follistatin has been shown to have great potential in treating a wide range of inflammatory and fibrotic respiratory diseases that
BioPharma Solutions, a business unit of Baxter, works with pharmaceutical companies to support their commercialisation objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems and customised support services needed to meet the unique challenges that parenteral products face. Parenteral manufacturing can be a complex process. Cytotoxics, antibody-drug conjugates (ADCs), highly potent compounds, biologics and lyophilised products require specialised understanding. Baxter’s facility in Halle/Westfalen, Germany, is reportedly the only company worldwide with facilities certified by SafeBridge carrying out both parenteral drug substance synthesis and parenteral drug product manufacturing and testing. Baxter has more than 80 years of parenteral contract manufacturing experience and provides world-class scientific expertise, state-of-the-art facilities and processes designed to help ensure a reliable supply of quality product to the market. Baxter’s facility in Bloomington, Indiana, US, is a leading contract manufacturer of prefilled syringes in North America and has more than 25 years of successful collaborations working with pharmaceutical companies in developing and launching their products. It was named ‘Best Contract Manufacturing Organization’ at the Vaccine Industry Excellence Awards three years consecutively.
affect over 300 million people worldwide. Our selection of DSM as Paranta’s biologics manufacturing partner is the culmination of an extensive global search process spanning more than nine months. We are looking forward to working with the Groningen and Brisbane groups of DSM Biologics as we continue the development and manufacturing scaleup of what we believe will be a truly exciting biotherapeutic.” Karen King, President of DSM Biologics, the business unit of DSM Pharmaceutical Products operating the Brisbane site, commented: “We are proud to announce that Paranta has selected DSM as its manufacturing and development provider. DSM will bring over 25 years of experience, a state-ofthe-art facility and an expert team in Brisbane to help drive the success of Paranta's lead project.” In addition to an R&D and manufacturing site in Groningen, The Netherlands, DSM is building operations in Brisbane, Australia, with the support of the Governments of Queensland and the Commonwealth. The Brisbane facility is DSM’s blueprint for its ‘biologics plant of the future’ for the production of biopharmaceuticals. DSM Pharmaceutical Products +1 973 257 8160 guy.tiene@dsm.com www.dsmbiologics.com / www.dsm.com/pharma
As a parenterals specialist, BioPharma Solutions offers outstanding delivery systems and a variety of manufacturing solutions to meet complex and traditional manufacturing challenges. Areas of expertise include: • Sterile manufacturing solutions — prefilled syringes, liquid vials, lyophilised vials, cartridges, diluents for reconstitution, ampoules, powder filled vials and sterile crystallisation; • parenteral delivery systems — frozen premix system, liquid premix system and BIO-SET Luer system; • drug categories — small molecules, biologics, vaccines, cytotoxics, ADCs, highly potent compounds and cephalosporins/penicillins. Baxter Healthcare Corporation +1 224 948 3278 laura_salo@baxter.com www.baxterbiopharmasolutions.com
Chemicals Specialist Strengthens CRO’s Management Team Harlan Laboratories Contract Research Services (CRS) has further strengthened its senior management team with the appointment of Dr. Robert Brown as General Manager, Chemicals. Brown has more than 10 years experience in sales, marketing and business development. He joins Harlan from BSL Bioservice GmbH, part of Eurofins, where he was Head of Sales and Marketing and has also held senior positions with MPI Research Inc, MDS Pharma Services and Charles River. At Harlan, he will be responsible for all global sales of chemical testing as well as taking charge of marketing activities within CRS. Brown has an honours degree in Chemistry and a PhD in Bio-Organic Chemistry, both from the University of Bristol, and carried out his post-doctoral research within the Frontier Research Programme at RIKEN, the prestigious government-funded research institute in Saitama, Japan. “We are delighted to welcome Rob to Harlan,” commented Harlan Laboratories CRS’s President Manuela Leone. “His experience and expertise in the chemical sector will be invaluable in EPM 26
ensuring that we continue to deliver the highest levels of service and support to our clients, tailored to their precise requirements. “Our three divisions — Chemical, Agrochemical and Pharma — are now each being led by experienced industry specialists, meaning we have one of the most knowledgeable and skilled senior management teams in the market, supported by the talented personnel throughout our organisation. Coupled with our ongoing investment in systems and processes, this will ensure we continue to offer speed and efficiency in the delivery of every project.” Harlan Laboratories Ltd +44 1332 792896 www.harlan.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP Site Expansion and New Technologies Investment Enable CMO to Cater for Pharma Industry SternMaid officially opened the extension to its Wittenburg plant, Germany, in September. After completion of this eighth phase of construction, in which the company invested €14 million, SternMaid employs a staff of 180, making it one of the biggest employers in the region. With the recent extension, SternMaid is entering a new business field and will in future be able to produce for the pharmaceutical industry as well as offer new products for the food sector. The Wittenburg company specialises in customised solutions for blending, processing and filling powdered foods, food supplements and APIs and excipients. The plant was established in 1996, originally as a production facility for the companies of the Stern-Wywiol Gruppe based in Hamburg. Although in the meantime, the Wittenburg factory no longer produces solely for the various units within the group, which specialises in functional ingredients for food and animal feed worldwide. SternMaid is now much in demand as a contract manufacturer in the international food market. From the start, SternMaid systematically enlarged its processing capacity and invested in advanced production technology in response to its
customers’ needs. The latest acquisition opens up totally new processing opportunities; with this investment, SternMaid is entering the realm of fluid bed technology, which permits a specific influence on the physical properties of solid products and their applications. Powders are dried, granulated, agglomerated or coated, depending on the intended application, and thus acquire a tailor-made profile. “Fluid-bed technology is one of the most important formulation methods in the pharmaceutical and food industries. With this versatile technology, we will be able to enter new markets with a promising future,” SternMaid’s Managing Director Stefan Schliesser explained. Two fluid-bed processors with different capacities form the basis of this new field of applications. A laboratory-scale pilot plant is available for test runs for developing and optimising new functional ingredients. Commercial-scale production is then carried out in a multipurpose industrial unit. The focus of the plant is on applications in the pharmaceutical and healthcare industries. In the case of the pharmaceutical industry, SternMaid has recently added to its specific range of services. For example, the counter-
By investing in the new fluid-bed processors, SternMaid is opening up new business fields. current container blending line that came into service in 2009 primarily for blending vitamin compounds has been qualified retrospectively and is now officially certified according to Part II of the EU GMP Guide. The fluid-bed unit is to be GMP-certified for pharmaceutical applications too. With the latest extension to the factory, SternMaid will be excellently equipped for new orders from its customers. The buildings now cover a total area of over
16,000 m2, lending capacities have been increased to 40,000 tonnes per year and the enlarged high-bay warehouse accommodates 20,000 pallets. To facilitate procedures, a new incoming goods area and a larger area for small packs have been created. SternMaid GmbH & Co. KG +49 40 28 40 39 75 nschulze@sternmaid.de www.sternmaid.de
Partnership to Develop and Market Gastro-Retentive Excipient for Solid Dosage Form Avantor Performance Materials has signed a collaboration agreement with Rubicon Research Private Ltd of Mumbai, India, aimed at combining the Indian company’s proprietary product technology with Avantor’s expertise in manufacturing and marketing to develop next-generation products for the functional excipient market. The goal of the partnership is to develop and market a gastro-retentive excipient that enables the delivery of molecules with a window of absorption. This excipient will enable the industry to develop more options in a niche segment
where the benefit of targeted delivery will result in significant therapeutic advantage. “We are delighted to be working with an exceptional partner like Rubicon in this development effort,” said Paul Smaltz, Executive Vice President of pharmaceuticals and the Americas for Avantor. “The combination of Rubicon’s groundbreaking technology and our strong position in the global marketplace for functional excipients will result in outstanding products to help our pharmaceutical customers in their pursuit of patient dosage compliance and safety.” The agreement calls for the companies
to collaborate on key elements of the process of bringing new products to the pharmaceutical excipient market, including optimised commercial manufacturing and production, full regulatory registrations and approvals from the FDA to move toward full commercialisation and potential licensing of the excipient materials. According to the two companies, they will work to launch initial products resulting from the partnership in 2013. “The Rubicon team is excited to work with Avantor in introducing this novel polymeric material as a functional
CRMO Announces Five-Year Extension of API Supply Agreement with Shire Albany Molecular Research, Inc. (AMRI) has entered into a multi-year supply agreement for an undisclosed product with Shire US Manufacturing Inc., of which the parent company, Shire plc, is a global company that focuses its business on behavioural health, gastro intestinal diseases, rare diseases and regenerative medicine. The agreement extends a previously existing agreement between the two companies and the terms are confidential. “We are pleased to extend this agreement with Shire,” said Thomas E. D’Ambra, Ph.D., Chairman, President and Chief Executive Officer of AMRI. “Our partnership lays the groundwork for AMRI to be considered by Shire for future development and manufacturing opportunities.” AMRI +1 518 512 2211 www.amriglobal.com EPM 27
excipient,” said Pratibha Pilgaonkar, Rubicon Research Chief Executive Officer. “This material will provide solutions to the global pharmaceutical industry for molecules with challenging therapeutic requirements, either from the pipelines of innovator companies or for lifecycle management opportunities for already marketed products.” Avantor Performance Materials, Inc. +1 610 573 2661 allison.hosak@avantormaterials.com www.avantormaterials.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP CDMO to Extend Capabilities with Purchase of Sofgels Business Patheon has entered into a definitive agreement with VION N.V., a global manufacturer of foodstuffs and ingredients based in the Netherlands, to acquire Banner Pharmacaps, a specialty pharmaceutical business dedicated to the research, development and manufacturing of gelatin-based dosage forms. Banner is said to be the world’s second largest pharmaceutical business focused on delivering proprietary softgel formulations for over-the-counter, prescription and nutritional consumer products, with four manufacturing facilities, significant proprietary technologies and products and leading positions in some of the industry's fastest-growing product categories. Banner is headquartered in High Point, North Carolina, US, with additional research laboratories and manufacturing facilities in the Netherlands, Canada and Mexico. James C. Mullen, Patheon’s Chief Executive Officer, stated: “The acquisition of Banner advances our strategic plan put in place in 2011, fully aligning with Patheon’s intent to be the leader in oral dosage development and manufacturing services. The transaction provides us with a well-balanced portfolio of proprietary products, stateof-the-art facilities with enhanced capabilities as well as an expanded geographical presence. We believe our visibility within the industry will be further strengthened as we pass the USD 1 billion-revenue mark.”
Environment Initiative Saves CRAMS Provider £72,000 Per Year
Peter Beckers, Chairman of the Board of Directors, Banner Pharmacaps, and executive board member, VION N.V., said: “Patheon shares many interfaces with Banner’s field of activities and offers opportunities for further growth over the coming years. The sale of Banner is a strategic transaction for both organisations. It allows VION to focus on its core business of food and ingredients, while aligning Banner with a global company that is known for its focus on quality and customer service in the pharmaceutical industry. We are convinced that this transaction represents the best outcome for Banner’s customers, partners and for our people, who will benefit from the scale opportunities of being a part of an organisation such as Patheon.” The acquisition will be structured as a purchase of all of the shares of the entities through which Banner conducts its operations, for a purchase price of $255 million, subject to working capital and other adjustments. The acquisition is subject to applicable regulatory approvals and other customary terms and conditions and is expected to close by the end of calendar 2012. Patheon Inc. +1 919 226 3200 doingbusiness@patheon.com www.patheon.com
Following the launch of pharmaceutical research, development and manufacturing company Almac’s new recycling initiative in May 2012, the amount of recycled waste has dramatically increased from 19% to 70% in just a couple of months and has since remained at around 70%. Almac’s environmental setup now consistently saves the company £6,000 per month. Thanks to a dynamic approach to recycling, Almac’s Antrim-based subcontractor McQuillan Envirocare manages all waste on site and new materials, such as aluminium, have been added to the recycling list. Unsightly open skips have been replaced by 100 different wheelie bins and mini recycler trains travel up and down the yards, keeping them in optimal condition. Beyond making Almac a greener place to work in and to live close to, haulage fees and landfill tax have decreased, encouraging further savings. Neil McCauley, McQuillan Envirocare’s Technical Manager, stated: “We work in partnership with Almac to ensure their environmental and sustainability obligations are met through current and innovative waste management techniques. As our largest client, Almac helped to create new jobs by the employment of dedicated McQuillan Envirocare staff and indirectly by securing several jobs already within our organisation. We value this close working relationship and look forward to continued success over the coming years.” Almac, one of Northern Ireland’s largest employers, is keen to
successfully carry out its environmentallyfriendly initiative not only in terms of its production waste but also in terms of office and household waste. Recycling bins are available in offices and staff are actively encouraged to use them and to change their environmental behaviour at work and hopefully at home. Wayne McMeekin, Almac Group HSE Manager, said: “Back in April 2012, Almac was recycling 19% of its waste. The original target agreed within our new environment initiative was to reach 40% in December. We are delighted that all our hard work has paid off to the point of reaching 70% waste recycling in June 2012 and maintaining a steady performance since, saving Almac £72,000 per year. This is a fantastic result, which benefits not only the company in terms of savings but also Northern Ireland and its residents in terms of enjoying a better quality of life and a solid reputation in terms of caring for their environment.” Almac Group +44 28 3833 2200 info@almacgroup.com www.almacgroup.com
UK-Based CDMO Secures Major Funding SCM Pharma has been conditionally offered over £1 million of funding as part of the Government’s £2.4 billion public and private financial support package. The company’s project was one of 130 across England selected for the Government’s Regional Growth Fund (RGF).
It is hoped the recent allocation of £1 billion of RGF money will create and protect around 240,000 jobs and attract billions of private investment to the UK. Dianne Sharp, Managing Director at SCM Pharma, said: “The allocation of the RGF comes at a vital time for the UK economy and will no doubt provide a
huge boost to companies across areas that need it the most. “It is a major vote of confidence for what we are doing here at SCM Pharma and comes at a time when we are investing almost £6 million into a new commercial manufacturing facility that will help us better meet the needs of our
clients requiring licensed medicines in niche markets. “I also believe it’s a big thumbs for the UK’s pharmaceutical manufacturing sector. The industry has faced a tough few years but this funding illustrates that specialist areas such as sterile manufacturing, which attracts business from across the world, are very much alive and kicking.” SCM Pharma specialises in formulation development and the sterile production of products for clinical trial supplies along with the supply of licensed drugs in niche markets for specialty pharmaceutical companies. The CDMO now has three sites in the UK and specialises in vial, ampoule and syringe filling, particularly with highly potent and toxic products that require aseptic processing using isolator technology. SCM Pharma Ltd +44 1661 833 693 info@scmpharma.com www.scmpharma.com EPM 28
SO WHAT’S NEW ?
Dr. Sue Miles, Clinical Trials & Customer Services Director, talks about the re-branding of AmerisourceBergen Corporation’s two packaging companies as AndersonBrecon, a single, full-service pharmaceutical packaging company, offering full-scale packaging solutions on a global scale, plus the opening of two UK facilities, one for the packaging of high potency products, the other for storage and distribution. Until June this year, we were two independent companies — Brecon Pharmaceuticals Ltd in the UK and Anderson Packaging, Inc. in North America. Both owned by AmerisourceBergen Corporation, Brecon Pharmaceuticals was bought in 2006, whereas Anderson Packaging was already part of AmerisourceBergen, and together they formed the packaging group within the corporation. Over the last three to four years, the two companies have worked more and more closely, building a global business for the packaging of both clinical materials and commercial products. Three years ago, on the clinical trials side, the brand AndersonBrecon Clinical Services was launched and we began to deliver a globalised strategy. This culminated earlier this year when the two companies decided that they were effectively working as one organisation and should therefore take the next logical step and rebrand. So, today we are AndersonBrecon Ltd. in Europe and AndersonBrecon Inc. in North America. We now offer global packaging solutions that span the entire product lifecycle from Phase 1 trials right through
to commercialisation. We’ve got 12 facilities across North America and Europe and we provide products to around 100 countries across the globe. For us, this event is all about how we are now a global business, our new image and how the combined offerings of a 30-year-old UK company and a 40-yearold US company can really benefit customers. There’s been a huge amount of interest. Our current clients, because we’ve kept Anderson and Brecon in the name, understand the linkup, so they’ve been excited to learn what the ‘other’ part of the organisation can do for them. With new or potential clients, it’s really that global reach that we’re aiming to highlight now and changing the market’s perception of the two companies to that of a single entity. We work with 19 of the top 20 pharmaceutical companies but we also work with many virtual companies both in Europe and North America. As a fullscale contract packager, it’s all about cultivating long-term, consultative partnerships, particularly with smaller clients. For example, if they’ve got a molecule in Phase 1, not only can we
help them through the clinical phases but they don’t have to jump ship when they are looking to commercialise their product. Also, as they near commercialisation in Phase 3, we encourage our customers to start making decisions about the look of their packaging, building the design into their later phase clinical trials so that it’s a much smoother transition from clinical to commercial. Often companies will wait until they have finished Phase 3 before considering what they want the commercial packaging to look like, which can lead to problems. Aside from the re-branding, in February this year we opened two new facilities in Wales. One is a specialty pharma centre in Talgarth, dedicated solely to the primary and secondary packaging of high potency products. There aren’t many standalone high potency facilities in the UK, so news of ours was well received by customers. We also opened a storage and distribution facility to accommodate the international trade we’ve built up. A lot of the clinical trials materials that we pack at our US facility are imported into the EU for local storage and distribution
around Europe. It’s located in Treforest, just outside of Cardiff, two miles from the M4, so ideal in terms of a distribution hub. Over the last couple of years there’s been a huge increase in demand for cold storage, so we’ve invested a lot in this and set up a -80˚C freezer farm, a room full of -80˚C freezers that are filling up pretty rapidly. This standalone storage service isn’t our core business, that’s packaging, but we handle a lot of challenging materials such as cytotoxics, hormonals, etc., so this specialised storage service is another area where we’re able to help with these. AndersonBrecon www.andersonbrecon.com
Dr. Detlev Haack, Pharmacist, Associate Director Research & Development, Hermes Pharma, provides an overview of the company’s exciting new research project involving several partners to co-develop coating formulations that have the ability to mask the unpleasant taste and smell of APIs in orally disintegrating granules. The main goal of the project is to achieve taste-masking of orally disintegrating granules and other dosage forms that can be taken without water. Currently, coatings are produced using polymethacrylates or cellulose. Although this is considered state-of-theart, the disadvantage is that the process involved requires a huge amount of solvents. In the food industry, lipids are used to coat ingredients, a process that has proved extremely effective and economical. Take pretzels for instance, a thin layer of lipids is applied to the salt that covers pretzels and it protects against humidity and resulting moisture. It is this concept that we, at Hermes Pharma, and our partners are looking to apply in the masking of APIs. There are currently five partners involved in this project — the Karl Franzens University in Graz, Austria, the
RCPE (Research Center Pharmaceutical Engineering), which has some 100 scientists in Graz, then Cremer Oleo is supplying the lipids and INNOJET Herbert Hüttlin is providing the equipment for the hot melt coating process. The project aims to deliver a number of key benefits, one of which is significantly reduced processing times. Normally, with a polymethacrylates coating, 30% of the coating consists of polymethacrylates and the rest is water or organic solvents but with a lipids coating you have a 100% lipids material, so the processing time is expected to be approximately 40% that of conventional processes. Another major advantage is that these lipids are pH independent. Acids such as citric acid are usually required by the formulation to produce saliva in the mouth. As these acids unfortunately
destroy pH dependent polymethacrylate coatings, the bitter tasting API dissolves in the mouth. With pH independent lipids, acids can be included in the formulation without impacting the coating and thus the taste. We look forward to promoting this technology as 100% natural, as it does not involve the use of any synthetic materials whatsoever in the process or the formulation — ‘green pharma’ in an ecological sense. With regards to timelines for availability, we are currently working on the first API, testing the first batches of five to eight formulations for stability, and expect the first results in the second quarter of 2013. We will test a number of formulations with one API, then move on and do the same with a second, by which stage we should have a technology platform for orally disintegrating granules.
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The regulatory phase will take some time because stability studies must be carried out, followed by bioequivalent studies. I expect the technology to be commercially available by the end of 2015 or the beginning of 2016, although this is an optimistic, best case prediction. Hermes Pharma www.hermes-pharma.com
SO WHAT’S NEW? Roger Viney, Director of Sales & Business Development at Hovione, highlights the company’s successful Quality by Design (QbD) filings for two New Drug Applications (NDAs), plus its focus on the custom synthesis business’ particle design services, highlighting the benefits of bioavailability enhancement and extended and controlled release technologies for both customers and patients. We grew by 24% last year, that’s a huge amount of growth and it is the result of being involved in different pharmaceutical business areas. One of the main strengths of Hovione is that we do not rely on just one area of business — we have the custom synthesis and the generic APIs businesses and within each we have sub-divided areas of specialism. Last year saw us involved in four NDAs with our custom synthesis business, two of which were QbD, a methodology now heavily endorsed by the FDA. Companies that can offer QbD filings are likely to be given accelerated review times, which obviously decreases the time-to-market. QbD allows you to be more flexible whilst at the same time achieve better quality. QbD is based on a more scientifically sound development process. We invest in a deeper understanding of the process during the initial stages and the benefits derived from this are highly advantageous from a long-term economics perspective because the number of failures and general process costs decrease. A traditional approach says that the raw material quality has to be ‘X’ and the process has to do ‘Y’ and that if you achieve tight control of the two, this ultimately results in the right product. QbD, on the other hand, says that you can cope with slightly varying quality raw
materials, within certain parameters, and you can do this by slightly changing your process, again within a controlled way. QbD is all about understanding the ‘raw materials-process relationship’ — a mathematically modelled relationship where a whole series of models can tell you that if you move ‘this’ way with your raw materials, you can move ‘that’ way in terms of your process — always guaranteeing the final product is within spec and of the highest quality. One further major benefit to QbD is that changes to the regulatory filings are simplified as the process is fully understood. Our main focus at this year’s event is our custom synthesis business’ particle design services. It’s about the power of bringing together and juxtaposing two offerings. It is well known that we are experts in complex chemistry but that is not enough today, it’s not as much of a differentiator as it once was. Of course, customers still rely on our chemistry capabilities but we now also offer particle design and have a number of technologies that deliver a host of value added benefits. After the complex chemistry stage, it is control of the powder properties and the physical aspects of the product that add value to a formulation. An important aspect is bioavailability enhancement because as molecules become more complicated they also become less
soluble. For example, the patient may only absorb 5% of the API, so 95%, although active, just passes through the body. Therefore, increasing the absorption to 10% will be of huge benefit to both the formulator, as they can save on costs, and to the patient, as they can take a lower dosage. This is just one example of how we can use our technologies in particle design to enhance the properties of an API. The molecular structure is defined by our customers but we can add value by improving the performance properties of the drug product. Another area where our particle design technologies add value is in extended or controlled release formulations. Patient compliance rates have significantly improved since the introduction of extended release technologies, especially in the US. Companies that have extended release formulations are able to extract enormous value from the market — the fact that the extended release version is essentially the same product but the patient only need remember to take one tablet a day instead of three is obviously going to make it the more favourable option. We connect our particle design offering with our generics business in the area of inhalation products. It is a technically challenging field where we remain very committed — designing our own devices, carrying out formulation
development and making APIs — and where we have special in-house technologies that allow us to develop inhalation APIs that give our customers a competitive advantage. When the innovator makes a dry powder inhaler product, they have some flexibility because they are responsible for the dossier and they define the specification. However, matching it is extremely difficult because the regulators are concerned that these products are equivalent. We are able to precisely control the particle shape, size and structure of an API, enabling us to produce bespoke inhalation APIs for our customers’ formulations so that they can exactly match the innovator products. Hovione www.hovione.com
Henry Hussell, Marketing Manager, Cargill Health & Nutrition EMEA, and Liesbeth Meeus, Application Centre Leader, Cargill Pharma & Personal Care, discuss the recently discovered benefits of excipient Zerose Erythritol for orally dispersible tablets (ODTs). Hussell: Over the last four years we at Cargill have made several discoveries and carried out patenting activity surrounding new pharmaceutical applications for Zerose Erythritol. Liesbeth has been heading up this effort at the Cargill R&D Centre in Vilvoorde, on the outskirts of Brussels, and she is best placed to give an overview of where we are up to. Meeus: As Henry says, Erythritol has been in our portfolio for some time, although the pharmaceutical grade — for which we have obviously had to obtain certificates of analysis for and carry out a significant number of tests — has been around four years in the proving. We compared Erythritol with our other pharma-grade polyols in our portfolio — such as Sorbitol, Mannitol, Maltitol and Isomalt — asking what specifically can it bring to solid dosage forms that these others do not? Being a polyol, we already knew it offered a pleasant feeling in the mouth and was therefore suitable for chewable tablets but then we also discovered that it offered off-taste masking properties. These off-taste masking properties were already used by the food industry, so we conducted a study in 2011 using Lascorbic acid (Vitamin C) as a surrogate for an unpalatable active. The study results clearly affirmed that Erythritol
changes the complete mouth feel perception of the pharmaceutical tablet. Then we took our research a few steps further. Firstly, we combined Erythritol with Sorbitol because Erythritol is not compressible on its own but combining it with another polyol makes it compressible. We started with Sorbitol as it is a known common binder. Then we combined Erythritol with Isomalt, which is non-hygroscopic, opening the door to Erythritol’s use for active-switch or moisture sensitive applications. We then discovered that more active could be added to Erythritol, thus providing higher dilution potential capability. We performed a study to evaluate Erythritol’s performance in three key areas for tablets that dissolve on the tongue. When compared with other polyols, Erythritol proved superior in terms of: one — overall mouth feel and taste perception, two — speed of dissolving and three — higher inclusion of actives. All of these properties are essential, as ODTs are intended to be taken without water in pretty much any situation at any time and are especially preferred by the young and old. This year we conducted a trial with a bitter active — Paracetamol (acetaminophen). This focused on offtaste masking for unpalatable actives, dilution potential and disintegration performance, to establish clear and
valid comparisons with Mannitol, the most usual polyol excipient for ODTs. Early results from an internal taste panel have proved very encouraging, with Zerose erythritol once again exhibiting excellent properties, and further trials are planned. We now have customer projects underway nearly all over the world, so we really already have a global approach to leverage this excipient further into the market. Hussell: As a result of the work we’ve done, there’s been an evolution if you like in terms of what we know about Erythritol and its performance capabilities. There’s this gap that has opened up between Erythritol and the other polyol excipients in our range. It was Erythritol’s off-taste masking capabilities that initially made it stand out against the others. Now we know it has better physical performance properties in terms of its ability to work with some of the moisture-sensitive ingredients and its ability to hold more active. For example, you can add up to 50% of Ascorbic acid and still maintain very good tablet integrity. Our objective now is to progress Erythritol as a high performance excipient for the reasons we’ve outlined.
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There is always going to be a place for polyols such as Mannitol but Erythritol really lends itself to ODT or chewable tablets containing actives that are absorbed in the buccal cavity, it’s an exceptional solution. Cargill www.cargill.com/products/ pharmaceutical/
SO WHAT’S NEW? Ian Shott, CBE, President, AMRI Europe, explains the real meaning behind AMRI’s SMARTSOURCING concept and the series of acquisitions that have led to its growth from a single-site drug discovery services provider to a globally operating organisation that also offers full-scale development to manufacturing services for pioneer and generic drugs. AMRI (Albany Molecular Research, Inc) was formed 21 years ago to provide drug discovery services. It’s now a global company and we have assets in Europe, Singapore and India as well as the US. We also provide a much broader scope of services now — 86% of the business is not discovery services — so our new positioning, AMRI Global SMARTSOURCING, reflects where and what the company is today. Our expansion has been mostly down to a number of acquisitions that were
made over the last 10 or so years and a major area of focus is the ‘seamless’ integration of all those acquisitions. At every one of our sites, the business language is English because we see this as a tremendous advantage from a regulatory compliance point of view. There is no translation of documentation from another language, which means there is no margin for error, particularly from a technology transfer standpoint. We strive to achieve a similar level of seamlessness with our standards and
therefore quality, so whether it is the UK, India or the US, we want to guarantee full compliancy. We’ve demonstrated our commitment to quality over the last year following successful regulatory and client inspections at all of those locations, which are now achieving similar standards. To an extent, the industry has become pigeonholed, with pharmaceutical companies showing a tendency to look for manufacturing services in Asia if they want to do things quickly and cheaply. However, the reality is that in China there has been inflation of around 20–25% per annum in areas where there are labs. We chose to go to India for two reasons, firstly because the GMP history in India is longer and secondly because the business language is English. While we are trying to homogenise operational and quality standards, we can also take advantage of the fact that our cost base in India is less than in the US. We do this by approaching projects in a holistic way, for example, one aspect may be very complicated, requiring the expertise of our best scientists in the US while another part might involve carrying out standard reactions that have already been proven elsewhere, so India is the prudent choice. We can divide the elements up but then pull them all together seamlessly. In this way, we believe we can offer customers the best solution from timeline, quality of work, productive output and cost perspectives. As an example, a major customer has just signed a multi-million pound contract with us and a key part of the agreement is the customer’s requirement to source from separate sites, i.e., keep European demand based on European manufacture and US demand based on US manufacture, which can be important from a regulatory point of view. With controlled substances, there are strict rules regarding how much you are allowed to manufacture in one zone and then supply to another and you have to obtain a quota from the Home Office when it’s in the UK or the Drug Enforcement Administration (DEA) when it’s in the US, therefore in some cases it makes sense to keep to the same zone and avoid potential quota issues. We now have a total of nine sites through which we are able to offer flexibility in terms of project scale, cost, location requirements and so on. Formulation development for solid dosage is carried out at our Albany site in New York and aseptic fill and finish at Burlington in Massachusetts. In addition to the UK site, commercial manufacturing is provided at Rensselaer, which is close to Albany, and at three locations in India. We are also committed to expansion in Singapore and India where we’re currently converting the Indian plant for pioneer drugs and generics manufacture. Out of all the companies exhibiting at CPhI this year, I don’t think you’ll find one other that covers the entire spectrum as we do from discovery services to mature manufacture of both pioneer and generic drugs, where at every site across three continents the core language is English. AMRI www.amriglobal.com
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Events REGULATORY AFFAIRS Extractables and leachables are increasingly becoming a cause of major concern for both the pharmaceutical industry and regulatory bodies. The development of unique packaging, novel formulations and drug-coated medical devices has exacerbated this issue. The FDA is demanding more and more information about every packaging component and its potential to interact with the final product. Furthermore, the increasing popularity of single-use disposables — such as filters, tubing and bags for biopharmaceuticals — can introduce unwanted extractables into the final product. Extractables are chemical species mostly generated by interaction between products and their packaging (gaskets, stoppers, storage bags, cartridges and prefilled syringes) over time, usually under extreme conditions, e.g., in the presence of strong solvents or elevated temperatures. Leachables are compounds that leach into the drug or biological product from the containerclosure system. Leachables are typically a subset of extractables and they generate as a result of direct contact with the formulation under normal conditions of use. In the case of plastic containers, typical extractables and leachables are additives and processing aids such as antioxidants and other stabilisers, plasticisers, emulsifiers and colourants but also monomers and oligomers of the plastic polymer and all kinds of reaction products. Useful information can often be obtained from vendors regarding the formulation of the polymer packaging but the issue remains complex as the full manufacturing chain from raw materials all the way to a plastic container involves different specialised manufacturers and full traceability is hard to obtain. Quite generally, containers meant to protect a drug from environmental contamination are themselves a source of contamination. In the pharmaceutical industry, it is not only containers that are a source of leachables. Combination products such as inhalers and pens or even more sophisticated medical device equipment like insulin pumps and implants may all leach unwanted chemicals. The regulatory perspective on safety qualification of extractables and leachables is an ever-green issue impacting on: • efficacy (e.g., leachable interacting with an active ingredient, resulting in a loss of activity); • safety (e.g., toxicity, immunogenicity and endocrine disruption); • quality (e.g., impact on the manufacturing process, product stability and interference with drug assays/medical diagnostic tests may increase the impurity level of a drug product, etc.). An area of increasing concern and scrutiny for the US FDA’s Center for Drug Evaluation and Research (CDER) is the potential adulteration of drug products by extractables and leachables that enter a drug from a container, closure system, disposable or device. From a manufacturing point of view, a crucial evaluation is the assessment of their place in the process stream (e.g., upstream vs. downstream). Typically, risks are greater as production moves closer to the finished product. The surface-to-volume ratio, contact time and type of polymeric material are further important points to consider and risk should often be assessed on a case-bycase basis. The Regulatory guidances on extractables and leachables are: • Federal Food Drug And Cosmetics Act; • Good Manufacturing Practices — 21 CFR (CFR 211.94 — Drug Product Containers and Closures and CFR 211.160 — General requirements); • EU Directives; • CDER Guidance Documents for Industry; • EMA and Health Canada Guidelines; • Standard Compendia — USP/EP/ICH Q4 (Annexures), Q6A, Q8. It can be challenging to effectively design a programme that will adequately address and evaluate the extractable/leachable issues associated with the container closure system, delivery devices and processing equipment. The concept of Quality by Design (QbD), originating from the platform principles outlined in the ICH, Q8R, Q9 and Q10 guidelines, reflects the current global regulatory thinking related to pharmaceutical products. QbD will ideally lead to better-understood products and manufacturing processes that will be subject to less variability in quality. A cornerstone of the QbD paradigm is the concept of a design space, a multi-dimensional combination of input variables and process parameters that have been demonstrated to provide the assurance of product quality. It has been proposed that this concept can be applied to the safety (leachables) assessment of drug products manufactured and stored in packaging systems. For an extractables and leachables evaluation to be meaningful and successful, QbD must be a collaborative approach on the part of the drug manufacturer, component vendor, analytical laboratory, toxicologist and regulatory agency. Each party has critical input and is a significant contributor to the overall process.
Exractables, Leachables and QbD
Written by regular columnist Dr. Paolo Biffignandi, advisory board member of the pan-European pharmaceutical regulatory affairs organisation ELC Group, with the assistance of Chetan Javia, Head of Regulatory Affairs at the ELC Ahmedebad office in India, and Lini Subin, Head of Regulatory Affairs at the ELC Mumbai office in India.
Mediplas Debut Hailed as Great Success Mediplas exhibition organiser Rapid News Communications Group (RNCG) has reported that the 2012 debut edition, held on 25–26 September at the NEC in Birmingham, UK, was a resounding success. Almost 5000 attendees came through the doors of the show and its co-located events over the two days, with the quality of visitors particularly high. Exhibitors have reported significant lead levels and many companies have already reserved their space for 2013. Sean Fryers, Marketing Manager at Connect 2 Cleanrooms Ltd, commented: “Mediplas was a good addition to our exhibition strategy for 2012. We had the perfect opportunity to get in front of companies who had a genuine interest in our modular cleanroom solutions. The free WiFi and extended free parking for visitors were a unique addition to the exhibition, which will hopefully set a high bar for other industry specific exhibitions in 2013.” Terry Whitmore, Managing Director of Henniker Scientific Ltd, was equally pleased: “This was our first time exhibiting at Mediplas and we were very impressed with both the number and quality of leads on both days. We were kept very busy with interesting new applications for our range of plasma surface treatment equipment and we have already reserved our place at next year’s show on the back of this.” Visitor Richard Fletcher, Managing Director at RF Works Ltd, summarised:
“Mediplas 2013 is the only exhibition to visit for everyone developing medical products.” The combination of cutting edge medical technology on show with no admission charges, free seminar sessions, free car parking and free visitor Wi-Fi proved a winning formula for visitors and the stage is now set for continued growth in 2013. Duncan Wood, Chief Operating Officer, RNCG, commented: “We are delighted with the feedback from both exhibitors and visitors alike. Their enthusiasm for the new show has been the catalyst for its success and special thanks must go to our speakers and exhibitors for their contributions. We now have a great foundation that we can build on for 2013.” Mediplas will take place on 25–26 September 2013 at the NEC, Hall 3a, in Birmingham, UK. RNCG +44 1829 770037 events@rapidnews.com www.rapidnews.com
Knowledge Management at Early Drug Development Summit Most of the major pharma companies are now engaging with QbD...many in the industry fail to understand how big a change in culture and practices it represents. It may be difficult at the onset for the initial development projects but ultimately the payoff will be great.” (Huw Kidwell, ‘Quality by Design — the new manufacturing paradigm’, 31/05/11). “World Trade Group (WTG) has announced that Andreas Schneider, Vice President Life Science Alliances, Roche, will be speaking at the Early Drug Development Summit, on 3–4 December, at the Hotel Palace Berlin, Germany. He will be sharing his industry experience on maximising drug investments by effectively managing early drug development pipelines through the use of knowledge management. His presentation will address: • using data management and information to support knowledge management in early drug development; • implementing QbD on individual steps of early development through to manufacturing; • using knowledge in unit operations to aid quality risk assessment; • utilising technical tools, software to gain knowledge out of data and identifying the gaps in knowledge management. The two-day conference offers preEPM 33
arranged, one-to-one meetings between 30 plus pharma industry solution providers and 120 plus drug development experts as well as real life case studies from leading drug development companies: Roche, GSK, AstraZeneca, UCB and more. Attendees will network with leading early drug developers to discuss maximising drug investments, toxicology, safety and biomarkers. Visit www.eddsummit.com to view the full programme. World Trade Group (WTG) +44 207 202 7690 michaela.melcher@wtgevents.com www.worldtradegroup.com / www.eddsummit.com
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To advertise here, please contact Rob Anderton: Tel: +44 (0)1829 770037 Email: rob@rapidnews.com
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HOSOKAWA ALPINE Aktiengesellschaft
CONTAMINATION CONTROL Helapet are a leading supplier of cleanroom disposables for hospital, pharmaceutical, electronic and laboratory cleanrooms providing solutions for contamination control in critical environments.
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INDUSTRIAL SERVICES
Gerhard Schubert GmbH
CHEMICAL CLEANING
Tel: +49 (0) 7951 400-0 Email: info@gerhard-schubert.de Web: www.gerhard-schubert.de
Transflow Industrial Services Limited The Passivation Specialists
Refurbishment, Decontamination, De-rouging, Passivation, Sterilization of your Stainless Steel & Pharmaceutical Plant on or off-site T: +44 (0)20 8591 3875 E: enquiries@transflow-industrial.com W: www.transflow-industrial.com
LABORATORY & R&D PRODUCTS AND SERVICES
FURNITURE
Teknomek Industries Ltd Tel: +44 (0)1603 788833 Email: sales@teknomek.co.uk Web: www.teknomek.co.uk
Fritsch GmbH
Weiler Engineering Inc
Tel: +49 (0) 67 8470146 Email: info@fritsch.de Web: www.fritsch.de
Tel: +1 847 697 4900 Email: solutions@weilerengineering.com Web: www.weilerengineering.com
ENVIRONMENTAL/STABILITY ROOM
PURIFICATION & FILTRATION PRODUCTS AND SERVICES
LTE Scientific Ltd Tel: +44 (0)1457 876221 Email: info@lte-scientific.com Web: www.lte-scientific.com
COATING EQUIPMENT & SERVICES
Glatt GmbH
PARTICLE SIZE ANALYSIS
Tel: +49 (0)7621 664 0 Email: info@glatt.com Web: www.glatt.com
Whitehouse Scientific Ltd Tel: +44 (0)1244 33 2626 Email: info@whitehousescientific.co.uk Web: www.whitehousescientific.co.uk
QUALITY AND COMPLIANCE SPECIALISTS
L.B. Bohle GmbH WEIGHING
Tel: +49 (0)25 24 93 230 Email: info@lbbohle.de Web: www.lbbohle.de
Mettler Toledo
OYSTAR Manesty
Tel: +44 (0)116 2345074 Email: enquire.mtuk@mt.com Web: www.mt.com/quantos
Tel: +44 (0)151 547 8000 Email: sales@oystar.manesty.com Web: www.oystar.manesty.com
TABLET PRESS SUPPLIERS
MANUFACTURING ANCILLARIES ELECTRONIC DRIVE & MOTOR REPAIRS
CONTRACT STERILISATION & TESTING
PUMPS
Fristam Pumpen F. Stamp KG Tel: +49 (0) 40 725 56 0 Email: info@fristam.de Web: www.fristam.de
EXCIPIENTS HPMC FILM COATING
Peristaltic pumps accurately transfer fluid through a sterile and fully validated tube from source to delivery.
BE HERE FOR A YEAR Call Rob on 01829 770037 or email rob@rapidnews.com
Tel: +44 (0) 1326 370370 Email: info@wmpg.co.uk
Web: www.wmpg.co.uk
ADVERTISERS’ INDEX Company
Page
Aiglon Bachem Baxter Biopharma Process Systems Dales Pharmaceuticals Denny Bros
28 18, 27 29 19 26 7
Diosna Driam Elizabeth Carbide Gerhard Schubert Mettler Toledo Müller
2 11 35 8-9 21 7
O’Hara Technologies
14 EPM 34
Optimal Automation Natoli Rapid WebSmart Sejong SVIAC West Pharma
1 36 12 6 14 32