Microbioz India, September 2018, Laboratory Issue

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The edition brings for you a cover story titled FEP tubing & its rising demand, accidental discovery of PTFE in 1938 by Dr. Roy J. Plunkett has turned out to have the lowest coefficient of friction of any known solid material. But as PTFE lacks the melt-processability, a need of other fluoropolymers was generated.

Market research

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When Bristol-Myers Squibb unveiled its price for Opdivo in China, industry watchers considered it a benchmark against which future immuno-oncology therapies will look to for their pricing strategies.

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Added to this, the current edition has a special featured article titled Amgen leaves celeb spokeswoman Blythe Danner behind in newest Prolia ad, Amgen osteoporosis drug Prolia is working to appeal to menopausal women with a new TV ad, but it's leaving behind celebrity spokeswoman actress Blythe Danner.

Product Launches

Merck follows Opdivo’s suit, prices Keytruda in China at half its U.S. tag: report

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The edition also covers recent Healthcare news articles and product launches collected from worldwide sources to update the readers with the current trends in the industry

U.K. court invalidates Gilead's Truvada patent extension, allowing PrEP generics 28 Activists in the U.S. are asking authorities to break Gilead’s patents on Truvada in an effort to help end the HIV epidemic. Now, a court in the U.K. has done just that, potentially allowing for widespread use of generics as a pre-exposure prophylaxis.

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ear friends and readers, I hope you would have enjoyed reading our previous issue. Once again, I am delighted to bring for you the new edition of your favourite magazine Microbioz India. It is a “Laboratory Edition” supported by the cover story titled FEP tubing & its rising demand by Shrikant Dethe (B.Tech. Chemical Engineer – IIT Bombay) Ami Polymer Pvt. Ltd. The accidental discovery of PTFE in 1938 by Dr. Roy J. Plunkett has turned out to have the lowest coefficient of friction of any known solid material. But as PTFE lacks the melt-processability, a need of other fluoropolymers was generated. FEP shares the same basic monomer and is commercially obtained by free-radical polymerization in an aqueous media via addition of tetrafluoroethylene (TFE, CF2=CF2) and hexafluoropropylene (HFP, CF3-CF=CF2). Structure of FEP is semi-crystalline, giving it not only a distinct and sharp melting point, but also generally better mechanical properties than those of the amorphous type of polymers. Sterilization of the tubing can be done by gas (EtO), steam (autoclave) and gamma radiation. We have the latest market research news and insightful product launches inside collected from worldwide sources to keep you updated with what is going on in the industry. Dear friends and readers, I hope you find some value in the magazine. Also, I would like to thanks you for being together in the beautiful journey so far. We will wait for your valuable feedback and suggestions as they help us to come up with better content each time. For any further value addition, please write to us at editor@microbiozindia.com.



Cover Story

FEP tubing & its rising demand Understanding FEP The accidental discovery of PTFE in 1938 by Dr. Roy J. Plunkett has turned out to have the lowest coefficient of friction of any known solid material. But as PTFE lacks the melt-process ability, a need of other fluoropolymers was generated. FEP shares the same basic monomer and is commercially obtained by free-radical polymerization in an aqueous media via addition of tetrafluoroethylene (TFE, CF2=CF2) and hexafluoropropylene (HFP, CF3-CF=CF2).

Operating working temperature: -240 °C to 200 °C

Mechanical: Low coefficient of friction Scope of FEP tubing Chemical: Resistance to virtually all chemicals

Properties of FEP Structure of FEP is semi-crystalline, giving it not only a distinct and sharp melting point, but also generally better mechanical properties than those of the amorphous type of polymers. Sterilization of the tubing can be done by gas (EtO), steam (autoclave) and gamma radiation.

Electrical: Low dielectric constant

General: Transparent Low flammability Antisticking nature High thermal stability

Weather: High UV stability

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Cover Story Applications Engineered fluoropolymer lining, tubing and fabricated products for aerospace industry relies onits ability to resist damage from aggressive chemical fuels and withstand wide variation in temperature. Retractable coiled FEP tube: In the recent years, the gradual downfall of PFA retractable coil has been observed due to its incompatibility with solvents. This has increased the consumption of FEP tube which serves greatly because of its high chemical inertness, heat resistance and flexibility. Additionally it’s used in chemical dispensers, deionised water re-circulators and even in heat exchangers. Further its non-stickiness nature makes a top choice in food and beverage processing industry. FEP tube is also used for hot sterilizing water transfer in purification system and UV water treatment.

How different is it from PTFE and PFA? FEP tubing’s inability to absorb materials, high chemical inertness and full sterilization capacity makes it ideal choice for sterile filling, diagnostic equipment, cell transfer and laboratory use.

Most of the properties vary slightly among these 3 fluoropolymers. x x x x

In electrical industry, FEP has well established itself due its low dielectric constant value& high electrical breakdown voltage property.

FEP and PFA can be extruded and thermoformed unlike PTFE. FEP has a lower working temperature than PTFE and PFA. PFA deforms more under load compared to FEP. This indicates better retractability for FEP. Better abrasion resistance of FEP than PFA.

This has resulted in the fact that in the whole family of recently developed fluoropolymers, FEP stands out in its range of applications. Current research is trying on a fluoropolymer which would resistharsh chemicals and is flexible too. This would serve for a large number of the applications and would serve universally.

Authored By: Shrikant Dethe (B.Tech. Chemical Engineer – IIT Bombay) Ami Polymer Pvt. Ltd. shrikant@amipolymer.com

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Event report

More than 9,500 visitors: Analytica Anacon India, India Lab Expo 2018 and PHARMA Pro & Pack Expo smashes all the records x x x

9,641trade visitors attended 261exhibitors from India and overseas at the trade fair trio Smart Lab Summit, Anacon India Conference and Buyer-Seller Forum well received

Hyderabad: With 9,641 visitors and 261exhibitors, analytica Anacon India, India Lab Expo and PHARMA Pro &Pack Expo has chalked up the best-ever result in its decade-old history and surpassed all expectations. The number of visitors rose by 25% over the previous edition in Hyderabad. Jointly held with PHARMA Pro &Pack Expo for the second year, the synergies between the trade fairs has resulted to setting of new records. Visitors from pharmaceuticals, chemicals, food processing, research and development among other segments explored the latest innovations from the laboratory technology, analysis, biotechnology, diagnostics, pharma packaging and processing. Almost all top companies within and around Hyderabad attended in large numbers and delegation trips were arranged by Messe Muenchen India for several companies.

“The most important innovation platform for the industry” In view of the new record figures, Bhupinder Singh, CEO of Messe Muenchen India, stated: “We are pleased with the positive results and with the positive feedback from our exhibitors on the quality of attendees. Large delegations from Hetero, Aurobindo, Karnataka Drugs and Pharmaceuticals Manufacturers Association, Indian Drugs Manufacturers Association among others attended. Huge participation at the networking forums has reinstated our position as the most important innovation platform for the industry.”

“Preparing for the future of research and instrumentation” Gautam Rajan, President, Indian Analytical Instruments Association on Anacon India conference said: “We organized the conference to cover advancements in analytical solutions for life sciences.

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Event report This is a very relevant topic today, because the future of research and instrumentation lies in this industry. There are many changes taking place and this conference addressed these changes and how the industry will cope with such changes.”

“Good footfall – we look forward to come back next year” One of the exhibitor representing Siemens Limited, Ajay Bhosle, Chief Manager – Healthcare& Pharmaceuticals said: We participated for the first time at analytica Anacon India and India Lab Expo where the footfall has been good and as per our expectations. We look forward to taking part in the next edition of the trade fairs.”

“Fifth time participation and many more to come” Keith Hulme, Director at Starna Scientific Limited said: “We have been participating at the show for the last four years. We connected with many customers who are interested in our range of products. We have been successful in developing our business these last four years and will continue to participate at the trade fairs to grow our business further.”

Excellent response at the supporting programs The analytica Anacon conference which took place on the opening day focused on Advances in and Analytical Solutions for Life Science Research, where industry stalwarts shared deep comprehensions about the state-ofthe-art development in the analytical industry. The esteemed speakers deliberated upon topics including Evolution of Life Sciences, role of advanced analytics, new methods for BioMolecular imaging, advanced analytics for biosimilar development: addressing safety and efficiency concerns and many others. The Smart Lab Summit, which took place on the second day of the event focused on the theme ‘Building your lab for tomorrow’ where prominent speakers from Aurobindo Pharma, Dr Reddy’s Laboratories, Lupin Limited, Reliance Life Sciences, Wockhardt and others deliberated on the need to move towards the smart laboratories, the need for investing smartly in Labs, transforming Laboratories through Big Data, and understanding the future of workforce in Smart Laboratories.

Business matchmaking at the BuyerSeller Forum Buyer-Seller Forum proved to be another important networking platform where 912 face-to-face meetings took place in three days, an increase of 7% from past edition. The discussions between participating buyers and exhibitors were fruitful. Delighted with the good response,Dr. Atul Kolte, Group Leader at Hetero Healthcare Limited shared: “This is indeed a great platform for the industry where we received useful information about various technologies and instruments on a single platform. I would like to thank to the organizers who have done a great job with these trade fairs, as well as for conceptualizing the buyer-seller forum.” The next editions of analytica Anacon India & India Lab Expo will take place in Mumbai (16-17 April, BEC) and Hyderabad (19-20-21 September, HITEX) in 2019. More details on <www.analyticaindia.com>, <www.indialabexpo.com> For PR and media enquiries contact Siddharth Narain, Messe Muenchen India, +91-9971600355 / siddharth.narain@mm-india.in

About analytica Anacon India and India Lab Expo Analytica Anacon India addresses the rapidly growing Indian market with exhibition sectors for analysis, laboratory technology, biotechnology and diagnostics. It is being held in conjunction with India Lab Expo, one of India’s leading trade fairs for analysis, laboratory technology and biotechnology. The next editions of analytica Anacon India & India Lab Expo will take place in Mumbai (16-17 April, BEC) and Hyderabad (1920-21 September, HITEX) in 2019.

About analytica worldwide Messe München is the world’s leading trade fair organizer for laboratory technology, analysis and biotechnology: Part of the analytica network are the trade fairs analytica China, analytica Anacon India and India Lab Expo in Mumbai and Hyderabad, analytica Vietnam and analytica Lab Africa.

Messe München Messe München is one of the leading exhibition organizers worldwide with more than 50 of its own trade shows for capital goods, consumer goods and new technologies. Every year, a total of over 50,000 exhibitors and around three million visitors take part in more than 200 events at the exhibition center in Munich, at the ICM – Internationales Congress Center München and the MOC Veranstaltungscenter München as well as abroad. Together with its subsidiary companies, Messe München organizes trade shows in China, India, Brazil, Russia, Turkey, South Africa, Nigeria, Vietnam and Iran. With a network of associated companies in Europe, Asia, Africa and South America as well as around 70 representations abroad for over 100 countries, Messe München has a global presence.

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Event report

8th Edition of PharmaTech Expo 2018 and LabTech Expo 2018 – Ahmedabad scales new heights As the pharma industry is increasingly looking towards India for high quality, low cost pharma solutions, The Edition of PharmaTech and Lab Tech Expo 2018, held from 22nd to 24th August 2018 at Ahmedabad, Gujarat, was a perfect place for companies to pick up on the latest trends and innovations the market had on offer. Major movers and shakers in India’s pharma machinery, technology and formulations industry gathered here in Ahmedabad to witness the latest trends and the competitive advantage that the industry had to offer to help grow their businesses. The event was inaugurated on 22nd August 2018. The dignitaries present during the inauguration include Shri. Jaimin Vasa, President , Gujarat Chamber of Commerce & Industry, Shri. P. K. Jha, Zonal General Manager, NSIC, Shri. Prakash Sanghvi, Chairman, Ratnamani Metals & Tubes, Shri Gautam Shah, Ex. Mayor, Ahmedabad, Shri. Nihar Lakhia, Joint Director & In Charge (WR), Federation of Indian Export Organisation (FIEO) and large number of entrepreneurs and industrialists.

PharmaTech Expo 2018 & LabTech Expo 2018 is an International Exhibition on Pharma Machinery, Lab, Analytical, Pharma Formulations, Nutraceutical & Packaging Equipments. The event provided opportunities to Suppliers, Manufacturers, Industrialists, Entrepreneurs, Buyers and Consultants to assemble at this common platform for networking and gaining knowledge on latest technologies and equipments available. This year the focus was on the Pharmaceutical Formulations, Nutraceuticals, API’s, Cosmetic and Ayurveda sector. Drug Marketing & Manufacturer's Association (DMMA) was the Event Partner.PharmaTech Expo 2018 & LabTech Expo 2018 put up a Largest Pharma & Lab expo in Gujarat & 2nd Largest Pharma machinery Expo in India. The exhibition was spread over in the space of 7500 square meters and en compassing 250+ exhibitors and the event was witnessed by 7000+ quality visitors from the different parts of the country. Various kinds of high tech Pharma Machinery, Lab and Packaging Equipment, Formulation, Nutraceutical products were on display. Successful deliverance of the past events of PharmaTech Expo 2011, 2013 & 2015 (Indore), PharmaTech Expo 2016 & 2017 (Ahmedabad) &

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Event report PharmaTech Expo 2017 & 2018 (Chandigarh) with patronage of our repeated and new exhibitors and visitors have encouraged the organizers for sequential events which has gained immense interest from pharmaceutical companies and manufacturers & 8th edition of PharmaTech Expo 2018 surpassed the previous events’ performance. Indo-African Chamber of Commerce & industry (IACCI) has organised reverse Buyer Seller Meet and invited 14 delegates from African countries including Botswana, South Africa, Sudan, Tanzania and Zimbabwe. During the three days interaction meet between Indian exhibitors, entrepreneurs and foreign buyers about 1000 meetings were held resulting into commercial dealing.

The event was supported by national and international organisations including, The Council of EU Chambers of Commerce in India (Mumbai), Food and Drug Control Administration, Gujarat (FDCA), Federation of Indian Export Organisation (FIEO) and IndoAfrican Chamber of Commerce & industry (IACCI).The seminar on Indian Pharma Industry: “Gearing for Global Giant” was organised by Food & Drugs Control Administration (FDCA Gujarat) on 23rd August 2018. Also seminar on “Current Trends in Compliance - The Role of Human Resources” was held on 24th August and supported by Pharma Knowledge Centre. The seminar on Indian Pharma Industry: “Gearing for Global Giant” was organised by Food & Drugs Control Administration (FDCA - Gujarat) on 23rd August 2018 on the below topics by the Speakers. Dr. S. P Adesara, Ex Commissioner FDCA, Gujarat delivered the keynote speech at the event..

Market Game: Generic v/s Branded - Mr. Shirish Belapure Managing Director, Zydus Hospira Oncology. Challenges & Impact of Bio Equivalence in Pharma Industry in Current Scenario - Mr. Nayan Prajapati, Head - Training , Cliantha Research. Quality Assurance of pharmaceutical products throughout the lifecycle by adopting Quality by Design (QbD) - Dr. M. C. Gohel- Ex. Principal, LM College of Pharmacy. Nearest Satellite in Regulatory Galaxy – PIC’s Compliance - Dr. D Roy Ex. Deputy Drugs Controller India. The seminar on “Current Trends in Compliance - The Role of Human Resources” was held on 24th August and supported by Pharma Knowledge Centre on the below topics by the Speakers. Pharmaceutical Culture of Quality - Dr. Deepak Haldankar - President – Technical, Akums Pharmaceuticals Ltd. Quality Culture and HR Role - Mr. Farhat Umar, Managing Director – Credo HR Solutions Charting the Path to Quality Culture - Ms. Deepti Patel, AGM- Quality & Regulatory, Ratnamani Healthcare Ltd, Ahmedabad The 9th edition of PharmaTech Expo & LabTech Expo 2019 will be held from 19-21 April 2019 at Chandigarh and 10th Edition of PharmaTech Expo & LabTech Expo 2019 will be held from 20-22 August 2019 at Ahmedabad. For further details please visit www.PharmaTechExpo.com

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Market research

Merck follows Opdivo’s suit, prices Keytruda in China at half its U.S. tag: report When Bristol-Myers Squibb unveiled its price for Opdivo in China, industry watchers considered it a benchmark against which future immuno-oncology therapies will look to for their pricq`ing strategies. Now it appears at least its arch rival, Merck & Co., has taken note for PD-1 competitor Keytruda.

The New Jersey pharma has priced Keytruda at 17,918 Chinese yuan ($2,600) per 100mg/4mL vial in China on the retail front, local business media organization Caixinreported. Compared with the drug’s U.S. price of around $4,800, that’s a 46% discount—about the same taken by Opdivo—and is also about 70% of its Hong Kong price. In addition, Merck is rolling out a patient assistance program (PAP) that will offer patients three additional months of free treatment after they pay for the first three, according to Caixin. Opdivo’s reported PAP entails six months of free drugs after five. BMS’ price for Opdivo was first made known in August, about two months after it became the first immuno-oncology agent approved in China. Its retail price is set at about $1,350 for the 100mg/10mL vial, nearly half the U.S. cost of approximately $2,600. Keytruda was approved in the emerging market in late July. While Opdivo directly went after the lucrative lung cancer market for its first China indication, Keytruda is now approved there in advanced melanoma, even though it has already shown the ability to slash lung cancer death risk by half when paired with chemo in first-line use. Lung cancer is the most common tumor type in China, with a total incidence of about 733,300 new cases a year, according to an official count for 2015. In comparison, melanoma only posted 8,000 new diagnoses in the country that year.

The difference in indications will probably limit Keytruda’s initial uptake. Of course, there will be offlabel uses for both drugs. But PAPs and future insurance coverage, if any, will be restricted to approved indications only. Because the two drugs’ costs—as with almost all innovative cancer drugs— are way above a person’s disposable income on average in the wealthiest cities of China, financial assistance will be key in ensuring their access. Both drugs will likely have a hard time getting onto the country’s national insurance scheme. For one thing, their costs might still be a burden on healthcare expenditure after steep discounts; second, Professor Yilong Wu, who led Opdivo’s Chinesespecific phase 3 trial, has said PD-1s are less predictive of the most suitable patients compared to targeted therapies, meaning the government will likely favor the latter for coverage. In the second quarter, Keytruda overthrew Opdivo as the new PD-1/L1 king, with $1.67 billion in quarterly sales, versus Opdivo’s $1.63 billion. Several domestically made checkpoint inhibitors might soon join the fray. Junshi Biosciences has also filed its PD-1 for approval in melanoma, and Jiangsu Hengrui Medicine and Innovent Biologics await Chinese decisions as well. Story source / Credit : The story is for information purposes and picked from https://www.fiercepharma.com authored by ,Angus Liu,Associate Editor

Racing with Merck, Pfizer wins FDA 'breakthrough' tag for 20-valent pneumococcal vaccine

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Market research Pfizer and Merck are racing to the market with their next-gen pneumococcal candidates, and on Thursday, Pfizer's program got a major boost. The FDA granted the company's 20-valent vaccine its Breakthrough Therapy Designation as the drugmaker prepares for late-stage testing. With the breakthrough designation, Pfizer can work with FDA officials on trial design and more, and its program could win accelerated approval and priority review under certain circumstances. The breakthrough designation is based on phase 2 data, and Pfizer plans to advance to phase 3 “in a few months," the company said. Meanwhile, Merck is already in phase 3 testing with its 15-valent program, dubbed V114. At a healthcare conference last week, Pfizer CFO Frank D’Amelio said the company is “all in” on

advancing its candidate. After Pfizer closed its internal neuroscience outfit earlier this year, the company shifted resources to accelerate the vaccine’s development, he said. The stakes are high. Pfizer’s Prevnar 13 already pulls in billions of dollars annually, and both drugmakers want to own as much of the market as possible. Merck entered phase 3 testing in April. Still, Pfizer executives have said they believe the drugmaker can launch its vaccine at a “competitive” time frame to Merck. If Pfizer's launch timing is competitive, D’Amelio said extra protection offered by the shot and the strength of the Prevnar franchise should allow the company to hold market share and keep growing its business. Merck R&D chief Roger Perlmutter, M.D., Ph.D., for his part, has said he envisions a need for multiple pneumococcal vaccines in the future. In one phase 3 study, Merck is testing its V114 in a head-tohead against Pfizer's Prevnar 13.

Merck and Pfizer are two of the largest vaccine companies globally, generating $6.5 billion and $6 billion in the field last year, respectively. Story source / Credit: The story is for information purposes and picked from https://www.fiercepharma.com authored by , Eric Sagonowsky,Associate Editor

U.K. court invalidates Gilead's Truvada patent extension, allowing PrEP generics

Activists in the U.S. are asking authorities to break Gilead’s patents on Truvada in an effort to help end the HIV epidemic. Now, a court in the U.K. has done just that, potentially allowing for widespread use of generics as a pre-exposure prophylaxis. The U.K.’s High Court overturned a patent extension for Truvada, meaning “that unbranded versions of the drug can be legally prescribed,” National AIDS Trust chief executive Deborah Gold said in a statement. She added that the development “represents a huge cost saving to buying a drug that would save public money, even at full price.” National AIDS Trust is calling on NHS England to fund the medicine by April 2019, arguing that a current trial program isn't reaching everyone at need.

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Market research A Gilead spokesperson told pharmaphorum that the company is disappointed with the decision and will appeal. Teva, Accord, Lupin and Mylan brought the patent challenge. RELATED: Gilead's Truvada for PrEP can reduce HIV rates, but activists decry unequal access Truvada's EU patent expired last year, according to the company’s annual SEC filing. Gilead secured supplementary protection certificates in several countries, which have come under legal challenges. The company’s U.S. patent expires in 2021, according to the filing. Gilead also has a patent settlement with Teva, allowing that company to launch a U.S. generic at an undisclosed date. Gilead's Truvada can be taken regularly as an HIV prevention tool, and activists in the U.S. recently penned a New York Times op-ed calling on the government to break Gilead’s patents to ensure equal access. Part of the activists’ “national strategy” to end the HIV epidemic includes “insisting that federal agencies use their statutory authority to break Gilead’s undeserved monopoly," they wrote. Less than 10% of people in the U.S. who could benefit from the drug in the PrEP setting are getting it, according to the authors. RELATED: Gilead takes HIV prevention message to TV, pushing PreP awareness with hipster ad At the time, a Gilead representative said the company is "committed to ensuring that people who are at high risk for HIV infection have access to Truvada for PrEP." He noted that the company supports "comprehensive payer coverage" and maintains an access program for "qualified uninsured and underinsured people" in the U.S.

The company also supports education programs, according to the spokesman.

Gilead this year launched a TV advertising campaign recommending viewers talk to their doctors about HIV prevention options. Truvada brought in about $3.1 billion in sales around the world last year. Story source / Credit : The story is for information purposes and picked from https://www.fiercepharma.com authored by , Eric Sagonowsky,Associate Editor

Amgen leaves celeb spokeswoman Blythe Danner behind in newest Prolia ad Amgen osteoporosis drug Prolia is working to appeal to menopausal women with a new TV ad, but it's leaving behind celebrity spokeswoman actress Blythe Danner. The new commercial instead centers on a group of four older active women. They take turns talking, noting that they have post-menopausal osteoporosis, which means a high risk for fracture. Danner has been starring in TV ads for Prolia since 2015. “We are proud of what we have been able to accomplish with Blythe Danner. Together, we have reached millions of women with the message that their bones are important and empowered women to speak with their physicians about postmenopausal osteoporosis and their bone health. We can’t thank Ms. Danner enough for her partnership in taking this journey with us,” said an Amgen spokesw oman via email. The new TV creative also tweaks the previous kicker, now asking “Are you on the path to stronger bones? If you’re not sure, ask your doctor about Prolia.”

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Market research The Danner ad that is also still running asks, “If your bones aren’t getting stronger, isn’t it time for a new direction? Why wait? Ask you doctor about Prolia.” The work for Prolia comes as Amgen and UCB await an FDA decision on a resubmitted application for next-generation osteoporosis treatment Evenity. Evenity, the brand name chosen for romosozumab if approved, was rejected by the FDA last year, flagged over the rate of cardiovascular side effects in its trial. The refiling was submitted to the FDA in July. A Global Data report in May noted that Evenity is forecast to win approval and hit the market in 2019.

It predicted the more appealing once-a-month dosing of Evenity, along with novel mechanism and strong efficacy, would do well, forecasting it to become a category leader by 2027 with a 17% market share.

Still, Prolia continues to be a workhorse for Amgen with $1.97 billion in global sales in 2017 and $1.27 billion of that haul coming from the U.S. alone. Prolia is the leading drug in the increasingly competitive osteoporosis category, but its set to lose patent protection in 2021. Story source / Credit: The story is for information purposes and picked from https://www.fiercepharma.com authored by, Beth Snyder Bulik, Associate Editor


Product launches

Analytik Jena Expands the Leading ICP-MS Series with a High-Performance 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). Analytik Jena has created a complete solution combining high-performance HPLC and technologically leading ICP-MS.

the measurement results also benefit from this. The detection limits here are in the ng/L range. 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. Additional information is available at: https://www.ajindia.com/products/analyticalinstrumentation/mass-spectrometry.html

“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 PlasmaQuant® MS and PQ LC significantly simplifies the detection of toxic and non-toxic element species.The precision and accuracy of Microbioz India, September 2018

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Product launches A new HPLC module for a very successful PlasmaQuant® MS mass spectrometer series — Analytik Jena has created a complete solution combining high-performance HPLC and technologically leading ICP-MS. Application Note: Determination of Arsenic Species in Beverages by HPLC-ICP-MS The species or chemical form of elements determines their mobility, bioavailability and toxicity. Liquid chromatography or ion chromatography allow a separation of these species. The subsequent detection by mass spectrometry provides a highly sensitive method for their quantification. Hence, LC-ICP-MS and IC-ICP-MS provide an essential tool for assessing benefits and/or risks of elements present in the sample. The developed method provides a robust and reliable tool for the identification of arsenic species in beverages. The obtained chromatograms for real samples reveal a stable

performance with good match of internal standard (AsB) signals. Stable retention times and a clear separation within seven minutes underline the robustness of the method. Combining the PQ LC, HPLC system with the PlasmaQuant® MS, ICP-MS offers an easy and sensitive solution for the identification of arsenic species in food samples. The method is ideal for routine testing of arsenic species in foods such as beverages.

Read the full Application https://tinyurl.com/yato8a2o

Note

Here:

Introducing the new NGI Assistant, a LabourSaving Device for Higher Productivity Inhaler Testing Hands-on demonstrations at Copley Scientific’s UK headquarters are proving the perfect introduction to the upgraded NGI (Next Generation Impactor) Assistant, a labour-saving device that boosts the precision and productivity of inhaler testing to unprecedented levels. Cascade impaction is used to determine the aerodynamic particle size distribution (APSD) of

all orally inhaled products; a critical quality attribute. The NGI Assistant automates the associated drug recovery process, making the conversion of NGI samples to solutions for HPLC analysis a simple, reproducible ‘load and go’ operation. The latest model offers shorter cycle times – boosting throughput and return on investment – and a simplified, easy-to- use interface. It frees analysts up for higher value work while at the same time improving data integrity by eliminating costly errors and operator-to-operator variability. To see the benefits first hand contact sales@copleyscientific.co.uk

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Product launches Author/source: Copley Scientific Limited Cascade impactors produce a series of size fractionated samples which are recovered and analysed to generate an APSD specifically for the active ingredient(s) within an inhaled formulation.

High-performance grinding down into the nano range Grinding has never been safer: instead of manually, the grinding bowls are automatically clamped by the mill – extremely easy and safe operation!

The NGI Assistant holds up to three complete NGI cup trays, but can also accommodate induction ports and preseparators, as required. Solvent is automatically dispensed by a robust, low maintenance liquid handling system to a volumetric accuracy of ~±1%.

The proven gentle rocking platform ensures complete dissolution of the drug and aliquots of the resulting solutions are then aspirated into standard HPLC vials for direct analysis. The new system can accommodate dual HPLC vial racks, offering the capability to collect both primary and back-up samples for each NGI test undertaken. It is compatible with a wide range of solvents and specified with vials for industrystandard HPLC systems (Waters and/or Agilent); customisation for alternative vials is also available on request. Substantially upgraded Windows- based software provides an intuitive interface, making it easier to customise methods and safeguard data integrity via a range of security and electronic records management features. In combination the hardware and software provide an efficient, highly reproducible, turn-key solution for automated drug recovery that can be used with confidence by multiple operators, throughout the lab.

With two grinding stations, we have developed the NEW FRITSCH Planetary Mill PULVERISETTE 5premium line as the ‘big sister’ to the PULVERISETTE 7 premium line: The ideal mill for fast wet and dry grinding of hard, medium-hard, soft, brittle and moist samples as well as for mechanical alloying, mixing and homogenising with reliable results down into the nano range – and an absolutely secure automatic clamping of the bowls by the mill. Your advantages with the Planetary Mill PULVERISETTE 5 premium line x

x x x x

Extra strong 2.2 kW drive power and extremely high centrifugal acceleration up to 64 g and up to 800 rpm (rotational speed of the bowl 1600 rpm) Sample quantities up to 450 ml, max. feed size up to 10 mm Motor-driven ServoLOCK clamping of the grinding bowls Safe and user-independent reproducible clamping 2 grinding stations for grinding bowls 125 - 500 ml volume

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Product launches x

Intuitive touchscreen operation with colour display

Grinding has never been safer With the completely brand new ServoLOCK clamping of the grinding bowls and the automatic check of the fastening of the bowls inside the mill, man and machine are optimally protected. In the event of impermissible operating states, the machine blocks the start of a grinding – and if an imbalance occurs it automatically shuts off. It doesn’t get any safer than this. Just insert the grinding bowl – start – done! Author/source: FRITSCH GmbH - Milling and Sizing

Active Temperature Control for Flow Chemistry in Glass Chip Reactors Uniqsis has introduced the Polar Bear Plus GSM™ - a versatile heating and cooling reactor module for flow chemistry applications using Glass Static Mixers / Reactor Chips (GSMs).

To achieve high reproducibility and facilitate scale-up the control of mixing and temperature is essential, particularly for highly exothermic or fast, mixing-dependent reactions. Uniqsis glass static mixer / reactor chips produce an efficient, turbulent mixed reagent stream that is not diffusion dependent. Compatible with all Uniqsis GSMs from 250μl to 20ml total channel volume the unit delivers precise flow reactor temperature control from – 30°C up to +150°C. The Polar Bear Plus GSM™ will accommodate all sizes of GSM from a single large chip, or using a conductive insert, up to 2 of the smaller GSMs. Customised holders are also available on request.

The Polar Bear Plus GSM reactor is easy to use and is completely self-contained, requiring only an electricity supply for operation - no cardice, refrigerants or messy heat transfer fluids. An insulated PTFE cover with view window allows GSMs be conveniently removed and refitted without the need to disconnect the fluidic connections. In addition to the manual control interface, the Polar Bear Plus GSM™ can be controlled remotely using the FlowSyn™ flow chemistry system or Binary Pump Module™. However, for maximum flexibility and, in particular for flow chemists who wish to build their own bespoke or a more complex component-based flow chemistry system, the Polar Bear Plus GSM is fully compatible with Uniqsis FlowControl II™ system control software. Author/source: Uniqsis Ltd

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Product launches

New compact process photometer – economical online monitoring of industrial wastewater and more

A perfect fit for any industry These process analyzers are a great fit for process analysis in the chemical, environmental, semiconductor, petrochemical, food and beverage, potable water, and energy/power sectors. Compact and easy to use, the 2029 Process Photometer is designed to monitor the process around the clock.

Metrohm Process Analytics presents the new 2029 Process Photometer, an integrated solution for 24/7 online analysis of critical chemical parameters in industrial processes and wastewater streams. This single-method system performs photometric absorption measurements in the visible light range and is available in several application-specific configurations for monitoring up to 2 process streams.

Sensitive, accurate photometric measurements Depending on the analyte and matrix, the determination ranges of the 2029 Process Photometer vary from trace Îźg/L to mg/L. The semi-automatic calibration function for seven calibration standards saves time and effort, producing accurate results you can rely on.

Customized for your application The process photometer is especially suitable for monitoring chemical analytes including phosphate, copper, chromium, ammonia, and much more. Metrohm Process Analytics can offer process analyzers which are configured for each specific application challenge. Sample dilution, extra reagents, or even a second sample stream can be added with the addition of peristaltic pumps in the modular wet part.

Robust design Strict separation of wet part and electronics ensures safe operation in harsh environments. With an Ingress Protection (IP) rating 66, the analyzer is guaranteed to be dust and watertight.

Diverse data communication possibilities Information including results, remote control and status info, can be communicated through discrete I/O (i.e. analog outputs digital in/outputs), MODbus TCP/IP (Ethernet), or Serial (RS232) communication.

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Product launches Remote control is possible through VNC (Ethernet). Results can also be exported to USB. Author/source: Metrohm AG

Compact Electronic Pipette Filler Perfect for Fumehood Use

Large buttons on the hand grip enable precise fine control of aspiration and dispensing of liquids. An integral LCD display displays selected aspiration speed which can be simply set with a button under the display. The UltraJet uses a rechargeable lithium battery, so there are no unsightly cables trailing from it and it comes complete with a self-adhesive bench holder for storage. EC compliant each UltraJet controller is supplied with an appropriate mains charger. Author/source: Porvair Sciences Limited

Compact in size, the UltraJet electronic pipette filler from Porvair Sciences is perfect for use even in confined spaces such as safety cabinets and fume hoods.

inVia™ Raman microscope aids discovery of rare mineral in alpine plants

The UltraJet pipette filler is quick and simple to operate. Its lightweight, ergonomic design ensures you can use it for extended periods of time without discomfort.

A team of scientists at the Sainsbury Laboratory Cambridge University (SLCU) have discovered a rare mineral in alpine plants. Vaterite, a form (polymorph) of calcium carbonate, holds enticing potential as a new material for industrial and medical applications. This is the first time that vaterite has been found in plants.

The UltraJet has a disposable syringe filter inside to protect it from over-filling and a snug neoprene collar to firmly grip the pipette and ensure good directional control. It has been designed to work with all sizes of pipettes from 1 to 25ml and will fill the largest in just 6 seconds.

The discovery of vaterite was made through collaboration between SLCU and Cambridge University Botanic Garden as part of an ongoing research project that is probing the inner workings of plants in the Garden using new microscopy techniques, including Raman spectroscopy.

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Product launches The Garden has a national collection of European Saxifraga plant species. Vaterite was found to be a dominant component of the protective silvery-white crust that forms on the leaves of a number of alpine plants. Dr Wightman said: “In this case, the inVia microscope not only identified signatures corresponding to calcium carbonate as forming the crust, but was also able to differentiate between the calcite and vaterite forms when it was present as a mixture while still attached to the leaf surface.” Dr Raymond Wightman, the Microscopy Core Facility Manager at SLCU’s microscopy facility, has a Renishaw inVia™ Raman microscope which is used for studying aspects of plant development and plant cell biology. He said: “This alpine work is just one small part of a number of projects that look at the inner workings of plants. We use the inVia microscope to identify and map molecules.” The microscopy facility consists of general light, confocal and electron microscopes. Dr Wightman said: “Our cryo scanning electron microscope (cryoSEM) allows us to view, in great detail, cells and plant tissues in their ‘native’ fully hydrated state by freezing samples quickly and maintaining cold under a vacuum for electron microscopy. The inVia is a unique capability that allows us to probe the biochemistry of plant tissues, cells and even subcellular compartments. It is good for live imaging; we can put a fresh sample under the microscope and get a spectrum within seconds. When the inVia was installed we were delving into the unknown as the lab has never used any other Raman systems. The inVia gives us new information compared to the dynamics and ultrastructural characterisation offered by the facility’s high-end confocal and electron microscopes.” The Renishaw inVia is integrated with a confocal laser scanning microscope (CLSM), allowing correlated Raman and fluorescence measurements. Dr Wightman is also investigating correlative FLIM-confocal-Raman microscopy for observing protein-protein interactions, 3D cellular organisation and distribution of molecular species.

This discovery is all the more exciting because naturally occurring vaterite is rarely found on Earth. This is the first time that it has been found in such a large quantity and the first time it has been found to be associated with plants. The collaborative work of the SLCU and Cambridge University Botanic Garden team is revealing fascinating insights into leaf anatomy and biochemistry as well as demonstrating the potential for Saxifrages to supply a new range of biomaterials Images of plants, courtesy of Paul Aston. Image of Dr Wightman, courtesy of SLCU. Author/source: Renishaw plc

ZEISS Presents Initial Release of APEER, its Digital Microscopy Platform for Applications in Science and Industry ZEISS presents the initial release of its cloudbased digital microscopy platform, known under the name APEER at the Microscopy & Microanalysis conference Microscopy users are now able to automatically process images in the cloud by leveraging application workflows for 3D reconstructions, staining or segmenting.

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Product launches Use cases at M&M demonstrate different workflows, from the acquisition of images to particle analysis and reporting. In addition to enabling the exchange of scientific applications on the platform, the plan is to promote collaboration between scientists and provide community-building functions, such as a discussion forum and the opportunity to swap data sets or build on existing workflows. Dr. Markus Weber, Head of the Microscopy business group, highlights APEER’s unique features: "With APEER, we are giving researchers the opportunity to concentrate more on their work and less on image processing by providing them with all the tools necessary to collaborate and build solutions for their specific research needs."

Peak Scientific has Launched its First HighFlow Hydrogen Carrier Gas Generator Peak Scientific, the global leader in gas generation for analytical laboratories, has introduced a new hydrogen gas solution to the market, the Precision Hydrogen Trace 1200. The Precision Hydrogen Trace was on display at JASIS on the 5th of September at the Peak

Matthias Gohl, Head of the Digital Innovation Partners, ZEISS' own, in-house competence center for digital transformation founded in 2016, adds: "Digitalization offers a wide range of opportunities for groundbreaking innovations, and this is where APEER will play an important role. ZEISS also aspires to offer

leading technologies and solutions for users working in a variety of different areas, ranging from research and academia to industry."

Scientific booth 7A-601, and is designed primarily for GC carrier gas use. The versatile new generator can also... be used for multiple GC detectors requiring hydrogen fuel gas such as FID and FPD.

A broad network of developers and test users from the field of scientific microscopy were involved in shaping the initial release. APEER is being gradually made available to scientific institutions and the industry.

A compact and stackable generator, the Precision Hydrogen Trace 1200 produces up to 1200 cc of carrier grade hydrogen gas at 99.9999% purity, suitable for carrier gas and flame gas at trace detection limits.

Author/source: ZEISS

Capable of supplying multiple GC instruments, the Precision Hydrogen Trace 1200 is an ideal single source solution for larger labs with multiple GC or GC-MS instruments and is also suitable for providing collision gas for ICP-MS.

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Product launches

Ed Connor, Product Manager at Peak Scientific, commented:

“Thermal FFF data has proved invaluable in advancing our research”, commented Professor Pasch “. He added “It allows us to separate and understand polymer species that we otherwise

‘We are delighted to introduce the Precision Hydrogen Trace 1200 to the market. As a compact single source hydrogen solution, the Precision Hydrogen Trace is ideal for larger labs which require carrier gas for multiple instruments, even if they only have limited available space for a gas solution.’

would not be able to, adding a new dimension to our analytical capability.”

The Precision Hydrogen Trace 1200 comes backed by Peak Protected global on-premise servicing and technical support and is available to order now.

the other Field-Flow Fractionation subtechniques, Thermal Field-Flow Fractionation can separate polymers not only by molar mass but also by chemical composition at the same time. Thus, Thermal Field-Flow Fractionation can separate two polymer fractions of different material but same molecular weight into independent peaks.

Author/source: Peak Scientific Instruments Ltd

Separation & Characterisation of Self Assembling Block Copolymers Postnova Analytics reports on how Thermal Field Flow Fractionation has been successfully used to elucidate the core microstructure, morphology and chain arrangement of selfassembling block copolymers.

This pioneering study was undertaken by the renowned research group under Professor H Pasch at the Department of Chemistry and Polymer Science, University of Stellenbosch (South Africa).

Thermal Field-Flow Fractionation is a technique which is ideally suited for the characterization of polymers, gels and nanoparticles using different organic solvents and to get additional chemical information about the polymers. Different from

The self-assembly of block copolymers (BCPs), as a result of solvent selectivity for one block, has recently received significant attention due to novel applications of BCPs in pharmaceuticals, biomedicine, cosmetics, electronics and nanotechnology. The correlation of BCP microstructure and the structure of the resulting self-assemblies requires advanced analytical methods. However, traditional bulk characterization techniques are limited in the quest to provide detailed information regarding molar mass (Mw), hydrodynamic size (Dh), chemical composition, and morphology for these self-assemblies. In the new study, thermal field-flow fractionation (ThFFF) was used to investigate the impact of core microstructure on the resultant solution properties of vesicles prepared from polystyrene-polybutadiene block copolymers (PS-b-PBd) with 1.2- and 1.4polybutadiene blocks, respectively. The researchers at the University of Stellenbosch were able to successfully separate, using ThFFF, micelles prepared from BCPs of similar PS and PBd block sizes. Furthermore, it was established that for the vesicles and homopolymers of similar surface chemistry and Dh, ThFFF was sensitive towards the inherent differences in morphology and chain arrangement, enabling the two polymeric species to be successfully separated.

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Product launches

The measurements for this research study were performed using a Postnova Analytics TF2000 thermal field-flow fractionation system coupled in series to MALS and RI detectors as well as a Malvern Instruments Zetasizer Nano system.

Advanced Chromatography Technologies offer their industry-leading novel ACE phases in 1.7 μm particles, so you can leverage both their unique chemistries and high efficiencies to achieve your ultra-fast separation.

Author/source: Postnova Analytics GmbH

x

Ultra-fast UHPLC separations with unique ACE selectivities – ACE® 1.7 μm

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Although there has been a great deal of emphasis in recent years on the use of sub-2 μm particle sizes for increasing chromatographic efficiency and decreasing method runtimes, phase selectivity remains the most powerful factor in altering resolution.

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Unique selectivity, high efficiency 1.7 μm ACE UHPLC columns ACE C18, C18-AR and C18-PFP phases ACE SuperC18, C18-Amide and CNES phases 3 HILIC chemistries available 7 μm Method Development Kits – 3 columns for the price of 1!

ACE Advanced, Extended and HILIC Method Development Kits are available in 1.7 μm particles! ACE 1.7 μm Method Development Kits group together complementary selectivities to aid in the separation of closely related analytes in your mixtures. Screening each phase under the same mobile phase conditions can help you achieve your desired separation faster and increase your lab’s productivity. Each kit contacting three 1.7 μm columns is available for the same price as a single column! For more information on ACE Method Development Kits – now including ACE HILIC – visit www.ace-hplc.com or email info@acehplc.com. Author/source: Advanced Technologies

Chromatography






RNI NUMBER: UPENG/2017/73675


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