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The special edition brings for you a cover story titled ‘Evaluating powder characterisation techniques for the optimisation of a dry granulation process’ authored by Tim Freeman, Managing Director, Freeman Technology and HartmutVom Bey, Vice President, Gerteis Maschinen + Process engineering AG.

Featured Post

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Added to this, the current edition has a special featured press release titled, “International Gas Detectors (IGD) have launched the TOC-625 Micro, a multi-channel gas detection system which can be configured with up to six gas detectors and two relay output modules” by Respo Safety Solutions Pvt Ltd.

Thailand lab Expo: 2018

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Generic Version of asthma drug launched in Denmark by Glenmark Pharma

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Glenmark Pharmaceutical Europe LTD has launched a generic version of Asthma Drug in Denmark. Seretide Accuhaler which is used to treat asthma.

Pfizer Inc recollects its piperacillin and tazobactam antibiotics vials from US market

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Pfizer Inc recollected their Piperacillin and Tazobactum vials after the detection of elevated levels of impurities which may results in decreased potency.

Thailand LAB INTERNATIONAL has strengthened its promising market place for laboratory technologies and equipment with business opportunities in clinical & diagnostics, analysis & testing, research & development, chemicals & safety, and calibration & metrology.

Microbioz India May 2018

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ear friends and readers, I am extremely grateful to you all for your love, support and guidance throughout all these years and making your instrumental contribution in the journey of your favourite magazine Microbioz India. With immense pleasure, here I release before you another special edition for the upcoming largest event ACHEMA going to be organized in Frankfurt, Germany.

The special edition brings for you a cover story titled ‘Evaluating powder characterisation techniques for the optimisation of a dry granulation process’ authored by Tim Freeman, Managing Director, Freeman Technology and Hartmut Vom Bey, Vice President, Gerteis Maschinen + Process engineering AG. The article presents a collaborative study between Gerteis AG, a market leader in the design and supply of premium roller compaction equipment, and Freeman Technology, specialists in powder characterisation, to identify powder properties that characterise dry granulates to support the optimisation of roller compaction processes. For more information, please turn to the cover story.

Added to this, the current edition has a special featured press release titled, “International Gas Detectors (IGD) have launched the TOC-625 Micro, a multi-channel gas detection system which can be configured with up to six gas detectors and two relay output modules” by Respo Safety Solutions Pvt Ltd. As always, the edition covers the latest market research news and product launched collected from worldwide sources to keep you updated with what is going on in the industry along with a pre-event coverage by Thailand LAB INTERNATIONAL 2018. I request you to check it inside.

Dear friends and readers, I hope you find some value in the magazine. Once again, I would like to thank you for your invaluable love and support. We are always eager to receive your valuable feedback and suggestions as they help us come with better content each time. For any further value addition, please write to us at editor@microbiozindia.com.

Cover Story

Evaluating powder characterization techniques for the optimization of a dry granulation process Authored by: Tim Freeman, Managing Director, Freeman Technology and Hartmut Vom Bey, Vice President, Gerteis Maschinen + Process engineering AG

D

ry granulation is a process applied to convert fine, powders into granular products that flow freely and perform efficiently in subsequent operations. The advantages of roller compaction include modest capital investment, low running and maintenance costs, and high energy efficiency, plus it is particularly suitable for moisture or heat sensitive materials and those that require ultra-high containment.

This article presents a collaborative study between Gerteis AG, a market leader in the design and supply of premium roller compaction equipment, and Freeman Technology, specialists in powder characterisation; to identify powder properties that characterise dry granulates to support the optimisation of roller compaction processes.

Controlling dry granulation performance Figure1. Shows a typical Gertiesroller compactor design. Dry powder enters via an inlet funnel, which typically incorporates an agitator to promote consistent flow. Feed and tamp augers control the flow of powder into the compaction zone between two press rollers. An additional hopper can be used for additives or when compacting small volumes. As powder flows between the rollers it is subjected to a controlled force to produce a continuous ribbon of consolidated powder. This ribbon passes into a rotor, breaking it into granules of defined size.

Machine selection depends on numerous factors including throughput, and requirements for: • roller heating/cooling • modified roller surfaces • wash-in-place/clean-in-place • regulatory compliance containment

Figure 1: The key features of a roller compactor

The primary parameter for controlling properties of the resulting granules is compaction force which defines the stress that powder is subjected to as it passes through the rollers. The other important parameter is gap width.

At any given force, thickness of the ribbon and the rate at which powder is conveyed to the rollers are directly correlated. In some machines, gap width is maintained at a fixed value, so variability in the feed directly impacts the amount of powder in the compaction area and the properties of the ribbon.

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Cover Story

Figure 2: Correlating granule properties with compaction force highlights strong relationships with bulk and dynamic properties

This can lead to fluctuations in ribbon and granulate properties. Gerteis machines feature a floating gap design meaning that the distance between the rollers varies to maintain a consistent compaction force and minimise fluctuations in the granules.

In summary, properties of the granules are controlled by manipulating the force and gap width.

This raises the question of how to characterise granules to support control of the roller compaction process to produce material that is optimised for manufacturing. A study was undertaken to investigate correlations between dynamic, shear and bulk properties of granules to assess which provides the most valuable data.

Investigating the correlation between compaction parameters and granule properties Granules were produced using a model dry granulation blend in a Gerteis MINI-PACTORÂŽ.

The resulting granules were characterised using a

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Cover Story

FT4 Powder RheometerÂŽ, to measure dynamic, shear and bulk properties [1].

In Phase I, six batches of granules were produced at different compaction forces to investigate the effect of compaction force on granule properties.

Roller speed, sieve size and roller gap were kept constant. Table 1 provides full of the experimental conditions.

Table 1: Experimental conditions applied to investigate the impact of compaction force.

Batches I, III and V were assessed using the full test capabilities of the FT4 Powder Rheometer.

However, initial results suggested that shear properties, including wall friction data, showed little correlation with changes in compaction force, suggesting they have limited relevance.

Therefore, only dynamic and bulk properties were measured for batches II, IV and VI. Identified.

Tests were conducted in duplicate and the RSD% of the resulting data was typically less than 5%.

Figure 1 shows a selection of the strongest correlations Figure 2: Correlating granule properties with compaction force highlights strong relationships with bulk and dynamic properties

As roller compaction force increases, compressibility of the resulting granules decreases, while permeability and conditioned bulk density CBD increase. This suggests that higher compaction forces lead to denser granules that exhibit more efficient particle packing, giving higher bulk density. More efficient packing also reduces the ease with which the volume of powder can be further reduced, i.e. lower compressibility, a change that would influence performance in a tablet press.

The permeability profile suggests that higher compaction may influence the level of fines incorporated in the granules.

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Cover Story

Fines typically reduce permeability by filling the interstices between larger particles so the observed increase suggests a reduction in fines at higher compaction forces. This would not be counteracted by post-compaction milling which simply reduces the size of overly large granules, rather than controlling particle size distribution.

Regarding dynamic properties, the aerated energy (AE) of the granules increases with compaction force. AE is the energy associated with inducing flow when powder is in an aerated or low stress state. Since AE is measured under consistent conditions, the observed increases consistent with increasing particle density. Denser particles are more difficult to aerate so the applied air has less effect on flow energy compared to lighter particles.

Basic Flowability Energy (BFE) of the granules increases with compaction force in a similar way to AE, though the relationship is less linear. BFE is the energy associated with forcing a powder to flow and is sensitive to multiple particle properties including stiffness, size and density.

Denser particles are more difficult to move under forced conditions so the rise in BFE with compaction force is consistent with the other data. However, the non-linearity of the relationship suggests that changes in size or stiffness may offset this effect at higher compaction pressures.

II, IV and VI were subject to dynamic, bulk and shear characterisation, but shear analysis was omitted for Batches I, III and V, because of its failure to differentiate the samples. To extend the investigation experimental data was also analysed at 9kN/cm compaction force.

Table 2: Experimental conditions applied to investigate the impact of roller gap width At both forces, gap width had clear influence on the bulk properties of the granules (see figure 3) with narrower roll gaps producing denser, efficiently packed granules. The permeability profile at 9 kN/cm is more marked than at 4.5kN/cm suggesting that at low gap widths the relatively high compaction force ensures efficient compaction, incorporating the majority of fines into a dense granule.

The fact that these data reveal no robust correlations for any other properties measured can be attributed to greater variability in the data.

Phase II of the study investigated correlations between granule properties and gap width.

Compaction force was maintained at 4.5 kN/cm, while gap width increased in six discrete steps (see Table 2). Roller speed was kept constant. Batches

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Cover Story

Generally, larger roll gaps are associated with less consistent granules as it becomes more difficult to subject the powder to a consistent consolidation regime as roll gap widens.

Conclusion

Direct correlations were observed between the dynamic and bulk properties of granules and the roller compaction force and gap width applied in their manufacture. Increasing compaction force produces denser, more free-flowing granules with lower compressibility and higher permeability.

Reducing gap width has a similar, but less pronounced effect.

Previous studies [2] have indicated that there is a direct correlation between the dynamic and bulk properties of granules and attributes of tablets produced from them. These results therefore suggest that multi-faceted powder characterisation can provide the data required to optimise roller compaction to ensure high performance of intermediate or finished products.

References: •

•

Figure 3: Gap width has a less significant impact on granule properties than compaction force.

Freeman R., Measuring the flow properties of consolidated, conditioned and aerated powders – A comparative study using a powder Rheometer and a rotational shear cell. Powder Technology, 2007 25-33, 174, 1-2.

Freeman T., In pursuit of wet granulation optimization.

Pharmaceutical Manufacturing, 2014, March

Guest Post

International Gas Detectors (IGD) have launched the TOC625 Micro, a multi-channel gas detection system which can be configured with up to six gas detectors and two relay output modules.

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he system is designed with advanced automatic set-up features. Once installed, all that is required to set-up the system is one click of a button.

Addressable gas detection systems allow you to quickly deploy an effective safety solution. The controller features auto-setup functions which enables auto-configuration of the gas detection system alarm levels, gas types and ranges.

The systems allow for the use of precalibrated detectors. Only a single cable is required to interconnect the controller, detectors and relay modules.

Addressable gas detection systems of this type typically save up to 70% on installation costs.

There is also a pre-wired version of the system using plug and socketed cables (TOC-625MCP). This version allows for installation by people with no gas detection experience.

Cables are available in 1M, 3M and 10M lengths which can be interconnected to make specific length cable runs.

Gases include: • • • • • • •

Flammables Carbon Dioxide 0-5000PPM Carbon Dioxide 0-5% Carbon Monoxide 0-100PPM Long Life Oxygen Depletion/Enrichment 0-25 % Hydrogen Sulphide 0-50PPM Chlorine 0-5PPM

625 MICROS is ideal for a wide variety of applications that require a small gas detection system, these can include: ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪

Boiler plant rooms Breweries: Micro breweries Pub Cellars Small laboratories Commercial Kitchens Schools: including: craft rooms, laboratory rooms, boiler rooms and class rooms for CO2 monitoring.

Underground car parks

Introductory Video link: https://youtu.be/Q_s_fa3hz2A For larger systems please contact us below, and for further information: Respo Safety Solutions Pvt LtdD-595, Kamla Nagar, Agra 282 004 Email: info@respoproducts.com Tel No: 1800-180-73776

Microbioz India May 2018

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Event report

Professional LAB Marketplace for Asia Thailand LAB INTERNATIONAL 2018

Press release – May 2018

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he 8thInternational Trade Exhibition and Conference on Analytical Laboratory Equipment & Technology, Biotechnology & Life Sciences and Chemical & Safety will return again during 12th– 14thSeptember 2018 at EH102-103, BITEC, Thailand.

Last year Thailand LAB INTERNATIONAL 2017 welcomed 9,165 trade visitors from 47 countries with 250 top companies from 23 countries, providing 840 business matching services along with various conference streamlines with 2,149 conference delegates and 160 speakers. The show is able to attract buyers and visitors from R&D, QC, Purchasing and Management in industries such as Food & Beverage, Chemical/Petrochemical, Biotechnology/Life Sciences, Universities & Educationists and Agribusiness/Agrichemical.

The visiting countries are China, India, Malaysia, Singapore, Myanmar, Japan, Vietnam, Cambodia, Laos, Indonesia, the Philippines, Taiwan, South Korea, Bangladesh, Saudi Arabia, Germany, Spain, the UK, the USA, etc.

analysis & testing, research & development, chemicals & safety, and calibration & metrology. The exhibition under the concept of ‘Technology, Network and Investment’, will bring the latest laboratory applications providing trade and knowledge exchange for the public and private sectors in Thailand and the region.

Thailand LAB INTERNATIONAL has strengthened its promising market place for laboratory technologies and equipment with business opportunities in clinical & diagnostics,

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Event report Thailand LAB INTERNATIONAL 2018 is still co-located with “Bio Investment Asia”, “LAB Safety Asia”, “LAB Chem Asia” and in 2018; Biotechnology, Medical Laboratory and Medical Science will be one of the highlighted sectors, with “Med LAB”, which is the new sector at this edition. In addition to the presentation of leading issues in biopharmaceuticals, laboratory safety and laboratory chemicals by invited international speakers and experts, the show will also welcome more than 1,000 trade buyers and participants from Asia Pacific and continuing the “Hosted Buyer Program” for our guests.

“The key reason to join at Thailand Lab is to build our brand image in Thailand and through this exhibition, we receive a greater volume of customers, and we were able to meet a very diverse group of customers from KOLs (key opinion leaders), lab managers, and lab technicians.

“This is a very critical part of our business portfolio, very professional setting, so we can showcase our solutions as well as our products to our customers in the region.

We participate in this event every year to engage with our customers in this region, especially in South East Asia.” said Ms. Yong Wee LIAU, Managing Director Asia Pacific, Romer Labs Singapore

Remember the date and join the leading laboratory trade exhibition in Asia.

Thailand LAB INTERNATIONAL 2018 will be held during 12-14 September 2018 at EH102-103, BITEC, Bangkok, Thailand.

If you are the LAB industry people and are determined to expand your market in Asia, consult our market developer to get the best solutions for your business at thailandlab@vnuexhibitionsap.com or call +662 670 0900 ext. 201-206 or http://www.thailandlab.com / http://www.bioinvestmentasia.com

Communication Team, please contact Mrs.Saengtip T. | saengtip.won@vnuexhibitionsap.com

This show offers such a broad customer base.” said Mr. Sean Maynard, Commercial Manager Microbiology -South East Asia, Thermo Fisher Scientific

Microbioz Microbioz India India MayMay 20182018

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Business News

Generic Version of asthma drug launched in Denmark by Glenmark Pharma

Pfizer Inc recollects its piperacillin and tazobactam antibiotics vials from US market

lenmark Pharmaceutical Europe LTD has launched a generic version of Asthma Drug in Denmark. Seretide Accuhaler which is used to treat asthma.

The Seretide Accuhaler has been produced by Celon Pharma whereas Glenmark has the marketing and distribution rights for the product across 15 European countries. It has been already said by Glenmark that ithas already received the National Marketing Authorizations for the product in Sweden, Finland, Norway & Iceland.

fizer Inc recollected their Piperacillin and Tazobactum vials after the detection of elevated levels of impurities which may results in decreased potency. According to the US FDA the product was manufactured in Chennai, India by Hospira Healthcare India Pvt Ltd, which is a Pfizer company having their plant at Irungattukottai near Chennai for Apotex Corp is to be sold in the USA. The Apotex Corp also notified their wholesalers and distributer to arrange for the return of any recalled product, through a letter.

Similar to it, AuroMedics Pharma LLC, which is a subsidiary of Aurobindo Pharmaceutical had also started recollecting the vials of piperacillin and tazobactam, it’s estimated that there will be around 77,400 vials currently to be recollected. Whereas Pfizer Inc has recalled over 1.8 million vials of piperacillin and tazobactam.

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"This is Glenmark's first inhaled respiratory product launch in Europe. Glenmark is the first generic company to receive regulatory approval for substitution in Denmark for its generic of Seretide Accuhaler," Glenmark Pharmaceuticals Ltd said in a BSE filing.

Glenmark has come in into a premeditated growth and licensing agreement with the Celon Pharma S.A to develop and market a generic version of GlaxoSmithKline’s Seretide Accuhaler product– Fluticasone/Salmeterol dry powder inhaler in 15 European countries.

Basically Fluticasone/Salmeterol dry powder inhaler is a combined product for the treatment of asthma & chronic obstructive pulmonary disease (COPD), it added.

Quotng IQVIA data, Glenmark Pharma said Fluticasone/Salmeterol dry powder Inhaler (DPI) had sales of USD 864 million in Europe in the 12-month period ending September 2017. Shares of Glenmark Pharma were trading 0.25 per cent lower at Rs 505 on BSE.

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As per the FDA, the product has been found to contain particulate matter, which is visible only after the reconstitution that was confirmed to be glass within the vial.

The piperacillin and tazobactam is used for treating different types of bacterial infection caused by bacteria. The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial, the FDA said."Piperacillin and tazobactam have been found to contain elevated levels of impurities that may result in decreased potency. The affected product is manufactured by Hospira Inc., a Pfizer

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Business News Company and distributed in the US market by Apotex Corp," the notification said.

As on May 14, AuroMedics Pharma LLC has not received reports of any adverse effect or identifiable safety concerns attributed to the product, it said

Pfizer, on third try, wins FDA nod for biosimilar of blockbuster Epogen/Procrit fter a couple of misfires, Pfizer has finally won FDA approval for its biosimilar of anemia drug Epogen/Procrit, a drug whose U.S. sales generated about $1.8 billion last year for partners Amgen and Johnson & Johnson.

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The FDA approved Retacrit (epoetin alfaepbx) on Tuesday for the treatment of anemia caused by chronic kidney disease, chemotherapy or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

“While launch timing will ultimately depend on a number of factors, we are moving ahead with the preparation of our launch plans for 2018,” Pfizer said in a statement that seemed to allude to patent litigation it has been fighting with Amgen.

issued a complete response letter and insisted that Pfizer produce more data for its application. The FDA liked the results of that additional effort and a year ago an FDA advisory panel voted 14-1 in favor of recommending approval.

A month later, however, the FDA again sidelined the drug with a second CRL. This time it was because the biosimilar was being manufactured at Pfizer’s Hospira plant in McPhearson, Kansas, that had been issued an FDA warning letter several months earlier.

The problems at the plant were laid out in a scathing warning letter that chastised Pfizer for repeated failings throughout the manufacturing network of Hospira, which Pfizer had acquired in 2015 in a $15 billion deal. The drugmaker promised to get on top of the problems and earlier this year, it indicated it had resolved FDA concerns about the facility.

While all of this played out, Amgen and J&J continued to reap the benefits of a having an exclusive three years after losing key patents.

Authored by Eric Palmer : www.fiercepharma.com

As far as pricing, Pfizer said only that “Retacrit is expected to be available in the U.S. at a significant discount” to the current wholesale acquisition cost (WAC) of Epogen and Procrit.”

Pfizer’s biosimilar candidate initially came up for consideration in 2015, but the FDA instead Microbioz India May 2018

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Business News

Suven Life Sciences gets patent approval from Newzealand and Norway for its product related with Neurogenerative Disease treatment

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uven Life Sciences, Hyderabad India based pharmaceutical company gets patent approval from Newzealand and Norway for its product related with Neurogenerative Disease

treatment.

The company informed that, these patents are valid till 2034 and 2027, respectively, the company said in a BSE filing.

"We are pleased by the grant of these patents to Suven for our pipeline of molecules in the CNS arena, which are being developed for cognitive disorders with high unmet medical need with a huge market potential globally," Suven Life CEO Venkat Jasti said.

The granted claims of patents are being developed as therapeutic agents useful in treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson's and schizophrenia, it added.

Amgen's Aimovig won its first-in-class migraine nod. Will payers step up to the $6,900 price? mgen and Novartis inaugurated a much-anticipated new class of migraine drugs Wednesday with FDA approval for Aimovig, an injectable med laden with blockbuster hopes. But Aimovig has several more hurdles to clear before it can reach those lofty goals.

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The partners need to win over payers that have already warned how costly this new type of medication—which targets the calcitonin generelated peptide pathway—could be to the healthcare system, and they've started by setting the price at $6,900 per year, lower than the $8,000 to $10,000 payers had warned against.

With a rival drug from Eli Lilly only months behind, Amgen and Novartis have a limited amount of time to make the most of their firstmover advantage. Already, an Express Scripts representative said the company will have a prior authorization program in place to manage access to Aimovig.

The approval is arguably more important for Amgen, which is bracing for new biosimilar competition for some key products, including the anemia drug Neupogen. But Novartis has its own financial challenges, including generic competition for its big-selling leukemia drug Gleevec, and with a political scandal raging, it can use this dose of good news.

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Business News With Wednesday's nod, the race is on. Amgen had the chance to set initial pricing in the class, VP of Development Rob Lenz said ahead of the approval, and now it can work to capture what he called "pent-up demand" for better migraine meds. "There's a lot of buzz in the field," he said of patient and doctor excitement for the drug. "This is the first preventative therapy ever designed specifically for migraine."

As Lenz pointed out, older migraine drugs were repurposed from other uses. That lack of purpose-built treatments is one reason why the cGRP class is so crowded, with other entrants expected from Teva and Allergan as well as Lilly. But Teva's drug, which might have been approved next month, will be delayed by manufacturing problems, that company said in February, giving Amgen and Novartis a little more runway for their launch than previously expected. Allergan's ubrogepant, expected to be the first oral CGRP drug, is farther behind, with a potential FDA filing next year.

Patients will appreciate a tolerability profile that's "similar to a sugar pill" and efficacy that can be seen within days, Lenz said. The once-monthly self-injection allows patients "built-in compliance" because they don't have to remember to take a pill every day, he said. Lilly's injection is also monthly, while Teva's has been tested with monthly and quarterly schedules.

Payers could be a tougher crowd, but Amgen may be able to apply some lessons it learned while launching Repatha, a PCSK9 cholesterol drug with blockbuster ambitions. It quickly ran into payer resistance, though, and uptake still isn't as strong as expected.

Sanofi—ran large outcomes trials hoping to show the drugs could deliver cardiovascular benefits. But even with data showing the drugs could reduce CV risks, the PCSK9 drugmakers have discounted their meds by 40% or more to gain coverage. The dynamics have led to sales far below initial projections.

Aimovig's approval closely follows a Praluent discount deal Maris sees as a potential harbinger of trouble for the new migraine drugs. For an exclusive spot on the PBM's formulary—and access to millions of patients it covers—Regeneron and Sanofi offered up big price cuts. The deal "does not bode well for the anti-CGRP drug class," Maris wrote this week. At the time of the deal, Bernstein analyst Ronny Gal called it a "capitulation," because of its tacit admission that the class will never become a major commercial success.

"When classes go exclusive, payers win," Gal said in a video discussing the deal.

Payers have been eyeing CGRP drugs already.

In a recent Reuters interview, Express Scripts chief medical officer Steve Miller suggested Amgen avoid the usual approach of setting a high list price and offering large rebates and discounts. The company could trying narrowing the "gross-tonet" gap instead, he suggested.

In a statement Thursday, an Express Scripts spokesperson said Amgen is "being responsible" with its Aimovig pricing. While citing "serious unmet need" for migraine sufferers, she said not all patients will need Aimovig. Express Scripts believes the drug is appropriate for patients who have failed on a previous preventative therapy.

With that considered, the company will "have a prior authorization program in place to help payers get the most value for the money they spend," she added.

Authored by Eric Sagonowsky: www.fiercepharma.com

In an effort to win favorable coverage, Amgen—and its rivals, Regeneron and Microbioz India May 2018

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Variable Power LED Reactor for Flow Photochemistry The Uniqsis PhotoSyn™ is a new high-power LED light unit enabling scalable flow photochemistry reactions yielding from milligrams to 100’s of grams per day.

By eliminating the control, scale-up and safety problems associated with traditional batch photochemistry – the Uniqsis PhotoSyn™ enables synthetic chemists to routinely take full advantage of the many benefits offered by photochemistry.

The PhotoSyn™ uses a pair of enclosed LED arrays to concentrate the light inwards onto a central coil reactor. Each array is composed of 260 individual 1W blue (455nm) LEDs making the unit particularly suitable for photoredox applications. These large format arrays provide sufficient light to facilitate reactions in coil reactors (up to 60 ml) allowing work at larger scale. Other LED array formats will be available shortly.

The PhotoSyn™ is compatible with both the Uniqsis Cold Coil™ standalone reactor module and the Polar Bear Plus Flow™ cryogenic flow reactor, which control the coil reactor temperature independently of the lamps.

Reactions may be run from 150°C down to sub-ambient temperatures dependent upon the power output required. The variable power supply allows the power output to be adjusted from 10-100% making the unit suitable for both small scale R&D and scale up applications.

All LED lamp units from Uniqsis have independent cooling and are hermetically sealed such that a compressed gas stream or a gentle flow of water can be applied at higher power outputs for additional cooling.

Since 2007, Uniqsis has specialised in the design and supply of mesoscale continuous flow chemistry systems for a wide range of applications in chemical and pharmaceutical research. The company’s aim is to make flow chemistry easily accessible to both novices and experienced users.

For more information: Visit Website www.uniqsis.com

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Product Launch

ZEISS Expands X-Ray Imaging Portfolio with ZEISS Xradia Context microCT Built on renowned ZEISS Xradia platform and field-convertible to ZEISS Xradia Versa X-ray microscope ZEISS introduces a new X-ray imaging instrument, ZEISS Xradia Context microCT, a large field-of-view, non-destructive 3D X-ray microcomputed tomography system. ZEISS Xradia Context is built on time-tested ZEISS Xradia technology, reaping crossover benefits of years of platform advancements and providing investment assurance as the system is uniquely capable of field-conversion to a ZEISS Xradia Versa 3D X-ray microscope (XRM), the instrument that set the bar in highperformance X-ray imaging in the laboratory.

ZEISS Xradia Context is a tomographic imaging solution for a variety of 3D characterization and inspection needs, from research applications in materials and life sciences to industrial use in product development or natural resource exploration.

Users easily adjust the system to image large intact samples to reveal interior details in their full 3D context, or small samples to maximize geometric magnification and resolve fine features with high resolution and high contrast.

ZEISS Xradia Context offers superb image quality, stability, and usability, along with an efficient workflow environment and high

throughput

scanning.

Lourens Steger, head of X-ray microscopy at ZEISS USA, says, “We continue to extend the capabilities of our XRM products in the field with newly offered functionality and modules to meet evolving customer needs. ZEISS Xradia Context joins this family and inherits the same commitment to extendibility that ensures an initial investment in advanced X-ray imaging technology will be protected well into the future. ZEISS Xradia Context enables customers to enter into the ZEISS Xradia ecosystem with a system to address their applications today, and room to grow as needed.�

With a robust stage and flexible softwarecontrolled source/detector positioning, users can image large, heavy, and tall samples using the new platform in their full 3D context. A high pixel density detector enables resolution of fine detail even within relatively large imaging volumes, as well as submicron spatial resolution for small samples. Rapid sample mounting and alignment, a streamlined acquisition workflow, fast exposure and data reconstruction times, and an optional autoloader make ZEISS Xradia Context a high throughput imaging instrument to meet a wide range of 3D imaging and characterization needs.

For more information : https://www.zeiss.co.in/corporate/home.html

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Product Launch

Sartorius Stedim Biotech Introduces Mini Microcarrier Bioreactor for Culturing Adherent Cells New vessel for ambr® 250 ht system will enable cost-effective, scalable process development of vaccines in cell culture Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry announce the launch of a new mini bioreactor vessel for its ambr® 250 high throughput (ht) system. This new vessel, which is designed for optimal growth of adherent cells on microcarriers will enable rapid, scalable cell culture process development of vaccines.

The single-use mini bioreactor for microcarrier culture has a working volume of 100-250 mL and features a single Elephant Ear impeller.

This impeller type generates optimum mixing and suspension of microcarriers, allowing adherent cells to grow over the entire microcarrier surface. The new mini vessel is based on cell culture bioreactors in the ambr

250 ht system. Utilizing this bioreactor on the ambr 250 ht system will allow rapid scale-up of optimized adherent cell culture processes to SSB’s BIOSTAT® STR range of pilot and manufacturing scale stirred bioreactors. This results in shorter process development timelines than would be achieved by scientists using benchtop bioreactors and spinner flasks.

Simple to set up and use on the ambr 250 ht, this new single-use mini bioreactor minimizes set-up and turnaround time. With up to 24 bioreactors per ambr 250 ht system, the technology is ideal for Design of Experiments (DoE) studies to optimize process development for vaccine manufacturing using a Quality by Design (QbD) approach.

The new vessel has been tested in collaboration with bioprocess experts at Aston University and University College London as part of an Innovate UK funded project. During these studies, all the cell culture parameters were controlled by the ambr 250 ht automated workstation. The results showed that the new microcarrier vessel design enabled growth to confluence of Vero cells on Cytodex microcarriers’ surface.

“There has been increasing interest in using microcarriers for culturing adherent cell lines in single-use stirred bioreactors as they offer a costeffective alternative to two-dimensional approaches for vaccine production using T-flasks and roller bottles,” stated Dr Barney Zoro, ambr Product Manager at Sartorius Stedim Biotech. “We are proud to be introducing our new ambr 250 mini bioreactor for culturing adherent cells at the BPI European Summit.“ For more information: https://www.sartorius.com/sartorius/en/EUR/h ome//

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Product Launch

Linkam Reports on how Astra Zeneca Study the Effects of Changes in Humidity on the Development of new APIs Market leaders in temperature-controlled microscopy, Linkam Scientific Instruments, report on how Astra Zeneca monitor changes in humidity and their effects on the development of new APIs. The work is being led by Dr James McCabe, Associate Principal Scientist based at the Macclesfield laboratories of Astra Zeneca.

Pharmaceutical compounds can also be exposed to aqueous environments or moisture during certain processing conditions such as wet granulation during tableting. This means the understanding of critical relative humidities for hydrate formation is of paramount importance.

To this end, Dr McCabe is always looking for optimum instrumentation to provide the maximum amount of data.

Dr McCabe talks about his experience in using humidity controllers and how he settled on the use of the RH95 system from Linkam. “I have used many humidity systems including dynamic vapour sorption (DVS) from various vendors as well as using them when making environmental X-ray powder diffraction measurements. The advantage of the Linkam RH95 humidity system used in conjunction with one of their temperature stages (THMS600) is that visual changes in crystal/particle morphology (size, shape etc.) can be observed in real time. The stage provides the added ability of then dehydrating samples via elevated temperature as part of the same experiment. This capability is also available on DVS systems, but the images are then macro as opposed to micro. An additional advantage is that in principle a single crystal of material could be assessed using the Linkam humidity system, a sample amount too small for other techniques.”

Dr McCabe's work with optical temperature stages has included the use of a new technique called TASC – Thermal Analysis by Structural Characterisation. TASC provides spatially resolved information on thermal transitions to images/movies acquired by temperature stage microscopy. It highlights any structural changes in the sample providing excellent complementary information with traditional forms of differential and modulated differential scanning calorimetry, DSC & MDSC, both being macro techniques.

Dr James McCabe is an Associate Principal Scientist in the Early Product Development Group (EPD) of Astra Zeneca based in Macclesfield in the UK. His research aim is to find the optimal solid form of an active pharmaceutical ingredient (API) for drug development and understand the risks and opportunities associated with that solid form.

This includes understanding and mitigating risks associated with hydrate formation as at least 25% of drug molecules can form hydrates.

Dr McCabe is optimistic for future exploitation of TASC in the pharmaceutical industry. “TASC appears to be a powerful thermo-optical technique for measuring optical changes within a sample. Glass transition and melting temperatures can quickly be measured, and complex mixedphase systems can be assessed. I will carry out further work to apply this technique to other areas such as crystal growth (induction times), dissolution and physical stability of amorphous materials when exposed to the combination of both temperature and humidity change.”

For more information: Linkam Scientific Instruments

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Product Launch

Independent White Paper Concludes: Quantum Technology ‘Successfully Addresses many of the Current Limitations seen in Single-Use Pumps’ Rigorous testing and data analysis from independent consultant, PDS Sandbox LLC offers conclusive proof that Watson-Marlow’s Quantum 600 peristaltic pump demonstrates an: “…excellent level of precision across a full range of pressures (up to 4 bar) with low shear that is approximately 50% lower than that of the Quattroflow QF1200SU pump from PSG Dover.”

This pump is ideally suited to filtration and chromatography applications with flows in the range of 3 to 20 liters/minute where high pressure, low pulsation and low shear are required.

Based upon the excellent accuracy of the Quantum 600 peristaltic pump, PDS Sandbox also recommends that this technology is used for the delivery of target volumes. In many cases, this removes the need for secondary checks (load cells, scales, flow meters). This provides a simple solution where, after calibration, the pump can be run at a set speed and time to deliver a desired volume accurately enough for a wide range of applications.

Commenting on the report, Tony Barrass, Product Manager at Watson-Marlow Fluid Technology says: “We are delighted with the overall conclusions of PDS Sandbox’s report and how well it highlights the superior performance of the Quantum 600 pump in relation to competitor products.

The results clearly support our claims that Quantum is both low pulsation and very low shear and also confirms that this innovative new design leads the way in offering linear flow control that is both accurate and independent of downstream pressure.

This advances what is possible with peristaltic technology in processes such as tangential flow filtration (TFF), virus filtration (VF) and gradient high precision liquid chromatography (HPLC).”

Published in a White Paper, the results and findings from PDS Sandbox also confirm that the Quantum 600 pump has minimal impact on CHO suspension cell cultures. The report’s opening abstract states: "This performance is better than would be expected with traditional peristaltic pumps and is comparable to the Levitronix PuraLev®200SU centrifugal pump but without the limitations of a strong pressure/flow dependency."

“We have always believed in our exceptional technology. However, to have independent validation reinforces our confidence in Quantum. This is important news for our biotechnology and pharmaceutical customers for whom accuracy across a wide range of pressures and flows and proof of very low shear is essential.”

The pump comes with a simple, intuitive control interface and is a robust flexible design with an easy to install single-use pump head cartridge which is reliable and fully validated.

To download a copy of the complete test report, please register here

For more information: www.watsonmarlow.com/in-en/

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Product Launch

Versatile 96-well MultiTier Microplate System for High Throughput Chromatography The patented 96-well Multi-Tier Microplate System (MTP) from Porvair Sciences and sister company - JG Finneran is a unique device providing analysts with the convenience of an ANSI/SLAS microplate footprint but loaded with inert glass vials.

Minimising the risk of extractables leaching out into samples to be analysed, the MTP accommodates a wide range of vial volumes enabling it to be used for a diverse range of applications. The MTP is formed of sections that can be clipped together to produce a vial holder suitable for 0.5ml, 1ml, 1.5ml or 2ml sample vials. The base plate has a vented bottom to allow uniform transfer of heat or cold to each of the vials and the secure fit of the vials permits use with shakers and vortex mixers during sample preparation. The entire unit can be capped with a pierceable cap mat to prevent contamination and evaporation, consequently the MTP is ideal for use in high throughput chromatography laboratories.

high recovery. Both types of vial can be quickly and easily loaded into the MTP shell using convenient pre-packed Vial Loader packs.

Being designed in the industry-standard ANSI/SLAS format, the MTP is compatible with most HPLC autosamplers and many other microplate handling devices, including the Porvair Sciences range of microplate evaporators.

For more information: Porvair Sciences Limited

Analytik Jena Expands the Leading ICP-MS Series with a HighPerformance Liquid Chromatography Module From now on, two high-performance technologies from Analytik Jena go hand in hand: Mass spectrometry with inductively coupled plasma (ICP-MS) and highperformance liquid chromatography (HPLC).

At analytica 2018 in Munich, the Thuringiabased company is presenting a new HPLC module for its very successful PlasmaQuantÂŽ MS mass spectrometer series. By doing so, Analytik Jena has created a complete solution combining high-performance HPLC and technologically leading ICP-MS.

The 96-well Multi-Tier Microplate System is available in a chemically resistant and highlytransparent Cycloolefin polymer (TOPAS) or Acrylonitrile butadiene styrene (ABS) for applications that require impact resistance, toughness, and heat resistance. Glass vials used in the MTP can be flat bottomed or tapered for Microbioz India May 2018

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Product Launch “The combination of PQ LC with our PlasmaQuant® MS is a winning formula,” says Ulrich Krauss, CEO of Analytik Jena AG. "By separating various species of an element using HPLC, the mass spectrometer can deliver even more precise results. Not only is this interesting for special analyses, but it makes an entire series of routine analyses more efficient, quicker, and more accurate. And does so without requiring more work by the laboratories.”

High precision is needed primarily in sectors that must be able to detect ever tinier traces of elements in their products and processes. For example, in the food industry the combination of Plasma Quant® MS and PQ LC significantly simplifies the detection of toxic and non-toxic element species. The precision and accuracy of the measurement results also benefit from this.

The detection limits here are in the ng/L range.

New sample preparation and concentration platform marks a major advance in automation of GC–MS workflows Markes International (Llantrisant, UK) has announced the launch of Centri®, a fully automated multi-mode sampling and concentration platform for GC–MS.

There are three versions of the PQ LC modules: The space-saving compact PQ LC for routine applications in small lab environments, the standard version of PQ LC for numerous routine and special applications, and the PQ IC ion chromatography system. Individual adaptations to customer requirements and subsequent retrofitting of existing PQ LC modules are also possible.

Rounding out the complete solution from Analytik Jena are intuitive controls and analysis software. In addition, a software interface enables the coupling of other HPLC systems to the PlasmaQuant® MS, providing customers with maximum flexibility.

For more information : https://www.analytikjena.de/en.html

The new instrument, which was launched at Analytica 2018, builds on Markes’ 20 years of excellence and leadership in the analysis of trace organic chemicals.

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Product Launch Centri uses marketing-leading robotics to reliably automate sampling and preconcentration of volatile and semi-volatile organic compounds (VOCs and SVOCs) through the following sample introduction modes – HiSorb™ high-capacity sorptive extraction, headspace, headspace-trap, SPME, SPME-trap, and thermal desorption.

Analyte flows from all modes can then be concentrated on a sorbent-packed cryogen-free focusing trap, using the same highly successful technology found in Markes’ range of thermal desorption (TD) instruments.

It’s this trapping and valve technology, says Markes’ Technical Marketing Director, Dr Massimo Santoro, that underpins several key advantages of the new system: “As well as enabling ppt-level sensitivity and allowing selective purging of interferents such as water and solvents, the trap and valve design used in Centri allows samples to be split and recollected onto a clean sorbent tube – a technology that we pioneered at Markes 20 years ago.”

concentration and GC injection for solids, liquids and vapours.

As Santoro says, this allows major productivity improvements to be made: “The use of robotics for all operations makes Centri ideal for many laboratories, especially those who are currently struggling with time-consuming manual sample preparation techniques, such as liquid–liquid extraction and solid-phase extraction.

In addition, Centri can desorb industrystandard thermal desorption tubes in compliance with standard methods. These tubes can either be packed with sorbents and used in conjunction with pumped, diffusive or dynamic-headspace sampling, or used to contain small samples of materials and foods, which are then desorbed directly.

For more information: https://www.markes.com/

“Since then, we’ve found that many analysts value recollection because it allows a single sample to be analysed multiple times. This approach brings numerous benefits to Centri now– for example, reduced need to carry out lengthy sample extraction steps to repeat an analysis, greater peace-of-mind by storage of valuable samples, analysis of a wider concentration range by changing the split flow ratios, and easy validation of complete analyte transfer.”

A principal feature of the new platform is that it automates the entire process of sampling, pre-

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RNI NUMBER: UPENG/2017/73675