Micobioz India, November 2019 Laboratory edition

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22 Cover Story 12 Dear friends and readers, I hope you would have enjoyed reading our previous issue.

Once again, I am delighted to bring to you the November 2019 a special edition of Microbioz India magazine for distribution in CPHI and P-mec India in the month of November 2019, supported by the cover story entitled “Pharmaceutical quality control: the reference standards labyrinth” authored by Martina Christiane Kotthaus, Ph. D, worked as Site Director at LGC GmbH in Luckenwalde, Germany.

Featured article 32 Added to this, the current edition has a special featured guest article entitled Automated Cell Counters to Witness Robust Demand with High Prevalence of Aids and Cancers” The insights are based on a report on Automated Cell Counter Market by Persistence Market Research.

Product Launches 36 The edition also covers recent Pharma news articles and product launches collected from worldwide sources to update the readers with the current trends in the industry

Uniaxial Powder Testing by Freeman Technology-a Micromeritics Company

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The Uniaxial Powder Tester (UPT) from Freeman Technology (a Micromeritics Company) is a unique stand-alone uniaxial shear tester for simple, sensitive and cost-effective powder characterization.

GSK to recall Ranitidine from India after regulator alert

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British drugmaker GlaxoSmithKline said it is recalling heartburn drug Ranitidine from India, a day after the country’s drug regulator asked pharma companies to check their products for carcinogen.

Dr Reddy's enters India's nutrition segment 31 with a drink for diabetics Dr Reddy's Laboratories on Thursday announced its entry into India's nutrition segment with the launch of diabetes nutrition drink 'Celevida'. "It is a first of its kind product under Dr Reddy's nutrition portfolio and clinically proven to help manage blood glucose levels among Indian patients", the company said.

Microbioz India, November 2019 08

ear friends and readers, I hope you would have enjoyed reading our previous issue. Once again, I am delighted to bring to you the November 2019 a special edition of Microbioz India magazine for distribution in CPHI and P-mec India in the month of November 2019, supported by the cover story entitled “Pharmaceutical quality control : the reference standards labyrinth” authored by Martina Christiane Kotthaus,Ph.D, worked as Site Director at LGC GmbH in Luckenwalde, Germany.

LGC, a global leader in the extended life sciences sector, with a comprehensive range of reference materials, proficiency testing schemes and research and measurement services, launched their latest white paper “Pharmaceutical quality control: the reference standards labyrinth”, by Dr. Martina Kotthaus, describing the different types of reference standards used by the pharmaceutical industry.

Added to this, the current edition has a special featured guest article entitled Automated Cell Counters to Witness Robust Demand with High Prevalence of Aids and Cancers” The insights are based on a report on Automated Cell Counter Market by Persistence Market Research.

The cell counting procedure starts with the loading of a sample into an automated cell counter, which is then passed through a narrow tube. Based on software-guided analysis, the automated cell counter uses either optical or electrical sensors to count the number of cells that successfully pass through the tube.

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 this beautiful journey so far. We would love to have your valuable feedback and suggestions as they help us to come up with better content each time. For any further valuable addition, please write to us at editor@microbiozindia.com.

Disclaimer: This disclaimer informs readers that the views, thoughts, and opinions expressed in the Articles, Advertisements published in the magazine belong solely to author and advertisers and not neccesarility to the authors employer, organization, committee or other group or individual.

The published material, adverts, editorials and all other contents published in Microbioz India magazine cannot guarantee and accepts no liability for any loss or damage of any kind of cause by this magazine and errors and for the accuracy of claims made by the advertisers.

Cover Story

Pharmaceutical quality control : the reference standards labyrinth LGC, a global leader in the extended life sciences sector, with a comprehensive range of reference materials, proficiency testing schemes and research and measurement services, launched their latest white paper “Pharmaceutical quality control: the reference standards labyrinth”, by Dr. Martina Kotthaus, describing the different types of reference standards used by the pharmaceutical industry.

Reference Standard, Primary A substance that has been shown by an extensive set of analytical tests to be authentic material that should be of high purity. This standard can be: (1) obtained from an officially recognized source, or (2) prepared by independent synthesis, or (3) obtained from existing production material of high purity, or (4) prepared by further purification of existing production material.

Types of pharmaceutical reference standard (RS)

When to use a primary standard?

In pharmaceutical QC, the use of reference standards to calibrate the analytical procedure is mandatory when measurements are performed with relative methods such as HPLC in combination with a UV or MS detector.

These measurements need to be traceable to a

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In the pharmaceutical area, there are four major types of reference standards: Primary RS Pharmacopoeial RS (for monograph use) Secondary RS Impurity RS

Apart from the pharmacopoeial standards, all of the above come with certificates of analysis (CoAs), or – in the case of a secondary RS – with a comparison statement. The information provided on the CoA should be suitable with regard to the specific use planned for the corresponding RS. There is a fifth type – research materials – which is often used at the very beginning of analytical research and development, but not normally for method development, validation, transfer or quality control.

Primary reference standards In the pharmaceutical context, a primary reference standard is a standard for which the properties (usually identity, very often also purity/assay values) have been characterized by certain analytical techniques, without, however, being compared to any other standard of the same kind.

The definition for a primary standard in the GMP guideline Q7 of the ICH states:

primary standard. This requirement is realized either by using the primary standard directly for the calibration purposes, or by using a secondary standard which is compared to the primary one.

ICH guideline Q7 states: 11.17 Primary reference standards should be obtained as appropriate for the manufacture of APIs. The source of each primary reference standard should be documented. Records should be maintained of each primary reference standard’s storage and use in accordance with the supplier’s recommendations.

Primary reference standards obtained from an officially recognized source are normally used without testing if stored under conditions consistent with the supplier’s recommendations.

Officially recognized sources, however, are not specified in Q7, but the FDA does mention sources in their ‘Guidance for Industry on Analytical Procedures and Methods Validation for Drugs and

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Cover Story Biologics’ but, interestingly, does not refer to these institutions as an official or definitive list: Reference standards can often be obtained from the USP and may also be available through the European Pharmacopoeia, Japanese Pharmacopoeia, World Health Organization, or National Institute of Standards and Technology.

Instead, the FDA states that “reference materials from other sources should be characterized by procedures including routine and beyond routine release testing” and that producers “should consider orthogonal methods for reference material characterization”.

For primary RSs, both the ICH guideline and FDA guidance allow other sources than the “officially recognized sources”. Independent manufacturers can provide such primary standards, ideally characterized by processes like those outlined in the general text 5.12. of the European Pharmacopoeia (Ph.Eur).

Correct use of primary reference standards: what to keep in mind?

In essence, a primary RS needs to be fit for its intended purpose. A pharmacopoeial RS has been shown to be fit for its compendial purpose, but has not been demonstrated to be fit for any other purpose; this needs to be proven by the user.

Consequently challenges of compendial standard use for non-compendial purposes have been reported in regulatory inspections. Other primary standards with fully documented CoAs can be used

for most applications, providing they have been characterized appropriately. If a primary RS is used to establish a secondary standard then the secondary RS can only be used for the same purpose as the primary one.

Pharmacopoeial reference standards Reference standards from the pharmacopoeias – also often referred to as compendial RSs – are, in principle, primary standards that have a special status for use in connection with the monograph methods for which they have been designed.

This position is specified in the USP (United States Pharmacopeia) general chapter <11>: When approved as suitable for use as comparison standards … in the United States Pharmacopeia (USP) or National Formulary (NF), USP RS also assume official status and legal recognition in the United States.

Assessment of the suitability for use in other applications rests with the user.

It is also described in the European Pharmacopoeia (Ph.Eur.) in general text 5.12.6: European Pharmacopoeia reference standards are shown to be suitable for their intended purpose; they are not necessarily suitable for other purposes. Any value assigned to a reference standard is valid for the intended use and not necessarily for other uses.

So, strictly speaking, the special status of a pharmacopoeial RS can only be assumed when the standards are used as required by the monographs.

For anything other than these monograph purposes, compendial RSs stand on the same level as RSs from other sources. This means that you need to prove suitability of a compendial RS for the desired non-compendial purpose in the same way you would need to for any other RSs. This is clearly mentioned in the Ph.Eur. chapter 5.12., and can be seen as a blueprint for other compendial RS use as well:

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Cover Story If a European Pharmacopoeia reference standard is to be used for any purpose other than that for which it has been established, its suitability for the new use has to be fully demonstrated and when applicable, to be described in the marketing authorization application.

The use of a compendial RS for non-monograph applications is also made difficult by the fact that certificates of analysis, which might otherwise provide a rich data set of characterization testing results, are normally not provided by the compendial institutions.

Impurity reference standard (IRS) Although the term ‘primary impurity standard’ does not really exist, any impurity standard that is not compared to another material of the same chemical structure and which is fit for its designated purpose can be considered such a primary material.

IRSs are designed to detect, identify, quantify and qualify impurities in a drug substance in accordance with the ICH guidelines (Q3A to Q3D and Q7).

ICH Guidelines 3A to 3D regulate the approach to impurities in the pharmaceutical industry. ICH does not prioritize at any point any given range of standards over another, whether officially recognized or not, for use within the pharmaceutical industry. According to these guidelines, impurities can be primarily classified into either drug substance or drug product impurities, referring in the first case to any component in the drug substance which is not the chemical entity itself.

A drug product impurity, meanwhile, is any chemical entity present that is not the drug substance or an excipient used to manufacture the drug product. Based on the cause triggering their appearance, impurities can be classified as starting materials, by-products, intermediates, degradation products or reagents/ligands and catalysts. Finally, by their chemical nature, impurities can be classified as organic, inorganic or solvents.

Pharmacopoeial IRSs, like all compendial materials, are designed for the specific monograph purposes.

For other purposes, an IRS from other sources suitable for the intended purpose should be preferred, for two major reasons: The use of a pharmacopoeial IRS outside the monograph can be challenged by regulatory

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authorities. Customers have reported to us that authorities have insisted on a CoA for a pharmacopoeial IRS used for non-compendial purposes. A CoA is not provided by pharmacopoeial sources, rendering the material unsuitable for use without separate detailed internal characterization.

Furthermore, supply of pharmacopoeial IRSs can be insecure. For example, there have been occasions where a change in a monograph has resulted in a neat impurity standard being replaced by a system suitability or peak identification mixture, usually consisting of a mix of the API and traces of one or more impurities. Such a replacement is not a problem if the user works according to the monograph methods. However, if the pharmacopoeial material is used for noncompendial purposes, the laboratory might face a challenge replacing the neat IRS if it is not available anymore. If the pharmaceutical company has stated the use of that specific material in their dossier, they may even need to report the change to the authorities. Cessation of supply is also a risk with any catalogue reference standard provided by a third party, but switching between suppliers is significantly easier when the materials are “primary” and accompanied by CoAs. In addition, the current regulation situation – especially for the finished dosage forms dealt with in ICH guideline Q3B – often requires additional impurity testing, on top of the requirements of the pharmacopoeial monographs. Then it can often be the case that there are no suitable impurity standards available from compendial sources, and the support of experienced commercial IRS manufacturers thus becomes necessary.

Secondary standards These compounds are second-line materials. They consist in each instance of a material that is compared against the primary material, and used in its place.

It does not matter whether the secondary standard is compared against a pharmacopoeial primary standard, or against a primary standard obtained inhouse or from a third source. A secondary standard can only be used for the same purposes as the primary standard. Thus if a primary standard was designed solely for a qualitative purpose (i.e. identification via IR, system suitability test or peak identification), then to use the corresponding secondary standard for quantitative purposes is not valid. For example, a large number of Ph.Eur. reference standards for APIs have been set up for

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Cover Story IR comparisons only, and should not be used as a basis for quantitative secondary standards.

In addition, the EDQM (European Directorate for the Quality of Medicines) does not recommend measuring secondary standards against even their quantitative materials. This is because: While pharmacopoeial primary RSs have a determined measurement uncertainty (MU) in line with the requirements of the relevant pharmacopoeial monograph, the value of this uncertainty is not currently specified.

The comparison of a candidate material for a secondary RS to the pharmacopoeial RS will result – by the principle of uncertainty propagation – in a larger but non quantifiable MU for the secondary standard, by virtue of the fact that the MU for the pharmacopoeial material is not published This unknown but enlarged MU for the secondary RS might no longer be appropriate for the acceptance interval specified in the relevant monograph.

For the same reason, the use of a pharmacopoeial RS with a non-compendial method can be difficult to justify on the basis that the uncertainty of its value assignment is unknown.

Research materials Often used at the very beginning of analytical research and development, these should not be employed when the methods are fully developed.

During validation and implementation in the QC or stability testing lab, they are usually replaced with better-characterized materials, especially when any quantitative purpose is connected with their usages.

Research materials come with only basic characterization data that makes them useful for initial development and identification work. They cannot be considered reference standards and can be distinguished from reference standards by their relatively simple CoA. Copyright © LGC Limited 2019 All rights reserved.

About author: Martina Christiane Kotthaus received her PhD in organic chemistry from the Westphalian Wilhelms-University in Münster, Germany, and performed her postdoctoral research in the laboratories of Prof. M. Schlosser at the University of Lausanne, Switzerland. She has more than 20 years‘experience in the pharmaceutical industry, starting as a research chemist in drug discovery at Hoechst Roussel Vet/Intervet, then moving into customer manufacturing of APIs, before various positions in R&D at DSM and Patheon (Thermo Martina Christiane Kotthaus Fisher Scientific). Since January 2019 Martina has worked as Site Director at LGC GmbH in Luckenwalde, Germany. She has published many articles in international journals and is the inventor of several patents.

For further details on Mikromol reference standards: Please contact: Jane Firth at LGC UK on jane.firth@lgcgroup.com or Suryakanth.G at LGC India – Suryakanth.gudgunti@lgcgroup.com

Microbioz India, November 2019

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Market Research

The Promising Rise of Biopharma to Translate into Accelerated Demand for Pyrogen Testing through 2029, Says PMR The new market intelligence report reveals that the global pyrogen testing market will reach US$ ~800 Mn by the end of 2019, and further exhibit a robust CAGR of 9% through the next decade. The increasing trend of outsourcing drug manufacturing to lowcost production regions by most pharmaceutical companies has been touted to remain a major influencer associated with the growth of pyrogen testing market landscape over the period of assessment, as it allows for low-cost skilled workforce and ease in tax relaxation.

Growing Number of Pharmaceutical and Biotechnology Companies to Bring Traction to Pyrogen Testing As medical devices cross the barriers within the body leading to contamination, pyrogen testing could be used by healthcare professionals to detect the harmful substances present in those devices. In addition, growing healthcare awareness also leads to upsurge in the medicine demand, which increases establishment of pharmaceuticals and biotechnology industries. This in turn, propels the demand for pyrogen testing in these establishments worldwide. Moreover, increase in number of people diagnosed with various diseases results in the rising demand for various injectable, vaccines, tablets, and other medicines in turn, fueling the demand for safety measures such as pyrogen testing.

According to the analysis, in end user, pharmaceutical companies will dominate the demand side in the pyrogen testing market by the end of 2019 and will also continue to exploit the highest share in the forecast period. This is due to the growing number of pharmaceutical establishments in developed as well as developing countries, which increases the need for drug safety checks like pyrogen testing.

Demand for limulus amebocyte lysate (LAL) pyrogen testing is estimated to grow by the end of 2029, as end users demands for user-friendly pyrogen testing method that are cost-effective, and

incur low equipment cost as well. Thus, the study report estimates that LAL pyrogen testing method will harness around 60% of the global pyrogen testing market share during the forecast period.

Favorable Government Initiatives to Augur Well for Pyrogen Testing Market Increasing spending by government bodies to develop effective drugs and medical devices is expected to drive the growth of the global pyrogen testing market in the forecast period. Pyrogen is a prominent cause that leads to shock or fatality among a large section of the patient population creating an economic burden on the country. Thus, increasing healthcare spending is expected to result in growing demand for pyrogen testing by various pharmaceutical and medical device companies.

Also, government in various countries are focused on prevention of infectious diseases to reduce associated healthcare costs, which in turn is expected to result in high demand for healthcare facilities.

In order to further complement this, government is focusing on pyrogen testing policies for contaminant-free medical devices and pharmaceuticals provided to the patient population, which will pave the way for the elevated requirement of pyrogen testing in the market. Hence, companies operating in the pyrogen testing market are expected to largely benefit from such developments.

These insights are based on a report on Pyrogen Testing Market by Persistence Market Research.

Microbioz India, November 2019

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Market Research

Global In Vitro Toxicology Testing Market to Reach a Value of About US$ 7,750 Mn in the Year 2022, Assays Segment is the Largest in Product & Services Type In vitro toxicology testing is carried out to identify the potential toxicity of new compounds when they are at an early stages of development during the discovery and development of new drugs. This type of testing is carried out to identity the presence or absence of certain toxins in drugs, agricultural chemicals and food additives. There is a sharp increase in R&D procedures which require in vitro toxicology testing and this is boosting the growth of this market along with latest technological developments. Moreover, the ban on animal testing has led to the increasing adoption of in vitro toxicology testing and the governments all across the world are providing increased funding for such type of testing.

The global in vitro toxicology testing market is slated to touch a value of about US$ 7,750 Mn in the year 2022 and grow at a robust CAGR during the assessment period.

Forecast Highlights on Global In Vitro Toxicology Testing Market As per the forecast of research study, the services segment is slated to touch a value of nearly US$ 2,400 Mn in the year 2022. This represents a robust CAGR growth during the assessment period of 2017-2022. The services segment is estimated to account for nearly one-third of the revenue share of the product & services type segment by the year 2017 and is forecasted to gain market share by 2022 over 2017.

As per the study analysis, the biochemical assays segment will reach a value of about US$ 1,800 Mn in the year 2017. This represents a robust CAGR growth during the forecast period. The biochemical

assays segment is forecasted to account for nearly one-third of the total revenue share of the method segment by the end of the year 2017 and is expected to lose in market share by 2022 as compared with the year 2017.

As per the study analysis, the pharmaceutical and biopharmaceutical industry segment is slated to reach a value of nearly US$ 3,500 Mn in 2022. The pharmaceutical and biopharmaceutical segment is expected to gain market share by the end of the year 2022. The largest share is contributed by the North America region in the pharmaceutical and biopharmaceutical segment.

Further, the report analysis states that cell culture technologies segment to exhibit a compound annual growth rate (CAGR) of 5% from 2017 to 2022.

The report has also included the profiles of some of the leading companies in the in vitro toxicology testing market like Promega Corporation, Charles River Laboratories International, Inc., SGS S.A., Qiagen N.V., Cyprotex PLC, Bio-Rad Laboratories, Inc., Merck KGaA, GE Healthcare Inc., Thermo Fisher Scientific Inc. and Eurofins Scientific Se. These insights are based on a report on In Vitro Toxicology Testing Market by Persistence Market Research.

Microbioz India, November 2019

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Interview

When we get what we have been dreaming and working for! we are successful Microbioz India, performed an interview with Sivaprasad Patnam, CEO, Analytical Technologies Limited, a leading manufacturer, supplier and exporter of Analytical, Chromatography, Spectroscopy, Biotechnology, Biomedical, Clinical Diagnostics and Material Science & General Laboratory Instrumentation, here I am sharing you a few lines of interview with him.

Question: How would you define “success” for someone in your chosen career?

Answer: When we get what we have been dreaming and working for ! we are successful. Like we had been dreaming to establish our Indian brand against the foreign multinationals like waters, shimadzu and Agilent, we are happy to share we are successful after decades of struggle, now many customers in India are accepting our products rejecting others.

Question: Sir, what do you consider the most important contribution of your academic experiences have made to Analytical Technologies Limited? What was your role?

Answer:Academic qualifications help you achieve your goals much easily compared to the one who’s not qualified , but what’s important is the passion , dedication , commitment more than the qualifications and certificates. As fas as our company ATL is concerned all the requisites like academic and passion, dedication, commitment helped. My personal role was to find solutions to make India self-sufficient and to provide import substitutes in highly innovative Analytical and scientific technologies space through our companies and brands like ATL and Multiple Labs.

Question: Sir sometimes it’s just not possible to get everything on your to-do list done. Tell me about a time your responsibilities got a little overwhelming. What did you do?

Answer: To get the things done , what we need is the leadership and bring the momentum in the team to achieve the common goals set by the company.

Question: Please tell me about a project that forced you to be innovative and creative.

Sivaprasad Patnam, CEO, Analytical Technologies Limited

Answer: The most challenging project was the Lab setup project we did for BSTI ( Bangladesh Standards Testing Lab), owned by the Bangladesh government where we set up standards testing labs for Food Safety, Water Testing, Chemicals Testing, Cement and bricks testing , and precision metals testing. This project made our teams more robust and forced to find solutions through innovation.

Question: Can you please let us know 3 things you like and 3 things you dislike about your current position.

Answer: I like our products, brands and team members.

I dislike government not taking initiatives to boost our analytical and medical technologies space, though we made series of representations through our IAMIMA (Indian Analytical and Medical Instruments Manufacturers Association), where am heading.

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Interview Foreign manufacturers dumping the rejected and used systems too Indian market as they get 100% advance through L/Cs. Customers still thinking only foreign brands can work

3. Happy to be founder of ANALYTICAL FOUNDATION, and the president of IAMIMA (Indian Analytical and Medical Instruments Manufacturers Association), a trust as a part of CSR activities.

Question: Sir, what are Your 3 Biggest Accomplishments in your career.?

Question: How would you like to define role of Analytical Technologies product and services for better quality control and production in BioPharmaceutical and Analytical Industry.

Answer: 1. Successfully establish our Analytical brand globally in the Chromatography space where HPLC, GC, IC, GPC against the big boys WATERS, AGILENT AND SHIMDAZU. 2. Happy to be founder of MULTIPLELABS, a lab setup/ Turnkeys solutions brand across the globe and successfully completed projects for industries life science, healthcare, railways, mining, forensic science food safety worth several million USD.

Answer: Innovation is possible only by research in lab and scaling to pilot and production of the natural extractions, synthesized products and APIâ&#x20AC;&#x2122;s. We provide Preparative Chromatography Purification Systems for lab, pilot and production scale for BioPharma.

For analytical industry we have been striving to be synonymous for our name Analytical Technologies, offering all kinds of technologies for analysis and research focussed into various groups Chromatography, Spectroscopy, Biotechnology Clinical Diagnostics, Material SCIENCES AND General Lab equipments

Microbioz India, November 2019

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Business News

US FDA pulls up Mylan for manufacturing violations at Andhra plant

The significant violations included failure to have adequate written procedures for the receipt, identification, testing and handling of raw materials American health regulator US FDA has pulled up Mylan Laboratories for violation of good manufacturing norms, including lapses in handling raw materials and issues related with cleaning of equipment, at its Andhra Pradesh-based manufacturing facility.

In a warning letter issued to the company's CEO Heather Bresch, the US Food and Drug Administration (USFDA) said inspectors during May 27 to June 5, this year found significant deviations from standard manufacturing practices at the company'Unit 8 in G Chodavaram village in Vizianagaram.

"This warning letter summarises significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API)," the USFDA said.

The significant violations included failure to have adequate written procedures for the receipt, identification, testing and handling of raw materials.

"Your procedures for receiving, identifying, testing, and handling raw materials were inadequate to ensure suitability of materials used in manufacturing, including preventing contamination

and cross-contamination with nitrosamine impurities such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA)," the US health regulator said.

The company had not anticipated the presence of NDMA or NDEA impurities based on its assessment of the API manufacturing process, it added.

It also pointed out to the company's failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications.

"There is no assurance that your cleaning methods are adequate to clean and prevent contamination or carry-over of drugs manufactured on non-dedicated equipment," USFDA said.

The inspectors observed that non-dedicated equipment were labelled as clean, however, when the interior surfaces of the chutes were wiped with lint-free clothes stains were observed, it added.

"Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting current good manufacturing practices (CGMP) requirements," USFDA said.

Until all corrections have been completed and FDA has confirmed corrections of the violations and the firm's compliance with CGMP, FDA may withhold approval of any new applications or supplements, it added.

In addition, the company's failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at the plant into the US, the regulator said.

The FDA issued the letter on November 5, and has given the company 15 days to respond.

Story source: PTI

Microbioz India, November 2019

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Business News

Merck, Bayer's trial win for heart failure rival could actually boost Novartis' Entresto Novartis' Entresto, the clear-cut market leader in heart failure, has been soul-searching since its highly touted trial in an untreated population fell flat.

Now, a surprise competitor has cropped up—but Merck and Bayer's upstart could actually give Novartis a boost.

Merck & Co. and Bayer's surprise phase 3 trial win for vericiguat—as an add-on to standard-ofcare for worsening heart failure patients with a reduced ejection fraction—actually included Entresto as one standard-of-care option.

And that could help pair the new blockbuster-inthe-making to Novartis' drug––a potential "rising tide lifts all boats" scenario, analysts said.

In a Monday note to investors, SVB Leerink analysts said Merck and Bayer's decision to pursue a phase 3 trial after the drug flopped its phase 2 monotherapy trial could tie the drug's chances to Entresto's blockbuster sales and help both meds commercially.

"This design could now be an advantage—flipping a competitive dynamic into a combination dynamic (assuming a large enough subgroup of patients did receive Entresto SoC)," the analysts wrote.

"This detail and others will be important in understanding how vericiguat will compete among an increasingly competitive group of branded therapies in heart failure."

Vericiguat's win could also be a non-issue for SGLT2 diabetes meds like AstraZeneca's Farxiga, which have also shown some benefit in heart failure. According to Evercore ISI analyst Umer Raffat, Vericiguat's focus on worsening chronic heart failure patients doesn't impede SGLT2s' pathway, focusing instead on a new indication.

Vericiguat, a guanylate cyclase stimulator, is also being studied in heart failure patients with a preserved ejection fraction, the same population in which Entresto flopped a phase 3 in July. However, sub data from that trial presented this past weekend gave Novartis hope that it can make another run at those patients.

Heart failure patients with an ejection fraction below 57% showed a stronger clinical response to Entresto than patients with ejection fractions above that threshold, according to a combined subanalysis from the Paragon-HF and Paradigm-HF trials presented Saturday at the American Heart Association Scientific Sessions.

Heart failure ejection fractions below 40% are usually defined as "reduced"––an indication in which Entresto is already approved to reduce the risk of CV death and hospitalizations––while fractions above 40% are defined as "preserved," an indication which currently has no approved treatment.

Novartis also presented a separate subanalysis from the Paragon-HF trial showing female heart failure patients with a preserved ejection fraction showed a stronger clinical response to Entresto than male patients.

Assuming Novartis spins that data into another trial for preserved ejection fraction patients, it could help the drug continue to boost its booming sales.

In the third quarter, Entresto brought in $1.6 billion, and the consensus estimate for peak sales currently sits at around $4 billion, according to Umer Raffat.

Raffat noted to investors Monday that vericiguat still has much to prove. Online top-line data are yet available from its Victoria study, after all.

And when details emerge, market-watchers will be looking for a 20% CV risk reduction on top of standard-of-care––particularly as an add-on to Entresto, Raffat figures.

"Vericiguat still needs to show strong data to have real commercial uptake," he wrote.

Story source/credit: The story is for information purpose and collected from fiercepharma.com authored by: Kyle Blankenship

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Business News

GSK to recall Ranitidine from India after regulator alert British drugmaker will suspend release, distribution and supply of the heartburn drug.

British drugmaker GlaxoSmithKline said it is recalling heartburn drug Ranitidine from India, a

day after the country’s drug regulator asked pharma companies to check their products for carcinogen.

“As a precautionary action, GSK has made the decision to initiate a voluntary recall (pharmacy/retail level recall) of Zinetac Tablets 150 mg and 300 mg products manufactured in India using API sourced from Saraca Laboratories Ltd,” a GSK spokesperson said in a statement.

Earlier this month, the US FDA had raised a global alarm over the presence of a probable cancer causing substance—NDMA or NNiteosodimethylamine—in some Ranitidine medicines.

GSK manufactures Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg (Zinetac) using API from Hyderabad-based Saraca Laboratories and another supplier, SMS Lifesciences India Ltd, for supply to the Indian market.

Subsequently, Saraca Laboratories was notified by the European Directorate for the Quality of Medicines (EDQM) that its certificate of suitability for Ranitidine Hydrochloride has been suspended with immediate effect.

GSK has been contacted by the Indian drug regulatory authority regarding the detection of genotoxic nitrosamine NDMA in Ranitidine products.

Based on the information received and correspondence with regulatory authorities, GSK made the decision to suspend the release, distribution and supply of all dose forms of Ranitidine Hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests and investigations,” added the spokesperson, clarifying that the product manufactured using API from SMS Lifesciences will not be recalled from the market at this point of time. However, all such all such products will remain on hold and they will not be released to the market till they receive test results.

GSK is continuing with investigations into the potential source of the NDMA. These investigations include continued engagement with our API suppliers.

Patient safety remains our utmost priority and we are taking this issue very seriously,” the spokesperson further said.

Ranitidine is a commonly prescribed medicine for countering acidity and is on the World Health Organisation’s Model List of Essential Medicines.

In India, a host of companies including GalxoSmithKline, JB Chemicals, Cadi Cadila Pharma, Zydus Cadila, Dr Reddy’s and Sun Pharmaceuticals sell over 180 versions of the drug.

Story source:ET Bureau

PureTech schizophrenia drug shows mid-stage promise PureTech has announced positive results from a Phase II trial of KarXT for the treatment of acute psychosis in patients with schizophrenia.

The company announced that in the trial, KarXT demonstrated a statistically significant and clinically meaningful mean reduction in total Positive and Negative Syndrome Scale (PANSS) score, compared to the placebo.

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Business News The drug also demonstrated good overall tolerability, and statistically significant reduction in the secondary endpoints of PANSS-Positive and PANSS-Negative scores were also observed.

Further to the findings, KarXT was well tolerated in the Phase II trial, with similar discontinuation rates between KarXT (20%) and

In addition to its novel mechanism of action, KarXT could be a new therapeutic option that has the potential to offer robust efficacy devoid of weight gain, metabolic effects and extrapyramidal side effects.”

At least one-third of patients with schizophrenia fail to respond to current treatments, with 74% of patients discontinuing within 18 months of initiation. The World Health Organisation ranks psychosis as the third-most disabling medical condition in the world.

Story source: Pharma times

Dr Reddy's enters India's nutrition segment with a drink for diabetics placebo (21%), with the number of discontinuations due to treatment emergent adverse events (AEs) equal in the KarXT and placebo arms.

The drug in question is an oral coformulation of xanomeline - a novel muscarinic receptor agonist - and is designed to treat psychosis and related symptoms through preferential stimulation of muscarinic receptors in the central nervous system (CNS).

The trial results are “impressive” and “encouraging”, said Jeffrey Lieberman, professor and chairman of the department of psychiatry, Columbia University, as they “indicate that KarXT, if approved, could represent a game-changing therapeutic advance in the treatment of patients with schizophrenia.”

He continued, “The effectiveness of antipsychotics has been limited by the frequent and serious side effects of first- and secondgeneration drugs which are difficult for many patients to tolerate, are potentially harmful, and lead to high rates of discontinuation and relapse.

Dr Reddy's 'Celevida' is formulated to have high protein, high fibre and slowly digested carbohydrates.

Dr Reddy's Laboratories on Thursday announced its entry into India's nutrition segment with the launch of diabetes nutrition drink 'Celevida'. "It is a first of its kind product under Dr Reddy's nutrition portfolio and clinically proven to help manage blood glucose levels among Indian patients", the company said.

Dr Reddy's 'Celevida' is formulated to have high protein, high fibre and slowly digested

carbohydrates, which will support in managing the postprandial blood glucose response and satiety, according to the company.

"We are pleased to mark our foray into the nutrition segment with Celevida, which will address the unmet nutrition needs of the patients in India.

Through this nutrition drink, we continue to work towards making a positive impact on people's health and quality of life," M V Ramana, chief executive officer, Branded markets(India and Emerging Markets) of Dr Reddy's said.

Story source: Business Standard Bureau

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Featured Article

Automated Cell Counters to Witness Robust Demand with High Prevalence of Aids and Cancers Automated cell counters are electronic devices that can automatically count the cells of humans, animals, plants, bacteria, viruses, as well as the cells of other origins. The cell counting procedure starts with the loading of a sample into an automated cell counter, which is then passed through a narrow tube. Based on softwareguided analysis, the automated cell counter uses either optical or electrical sensors to count the number of cells that successfully pass through the tube. Depending upon the device models, the time taken from sample loading to result output can vary from 30 seconds to 5 minutes.

For medical and research purposes, automated cell counters can be used for blood or urine analysis, as well as to determine the cell count to check the viability of the cultured cell lines meant for research activities. Some automated cell counters are used for blood analysis and others for urinalysis. The features that are unique to different automated cell counters include sample size, cell type, and capacity to differentiate between live and dead cells.

The market for automated cell counters comprises of different types of systems and reagents. In the automated cell counter market, the systems are available in the form table-top devices and devices that vary based on their image analysis technology.

According to study, among all the systems, coulter systems were the leading systems in the global automated cell counters market in terms of revenue with a global market share of 33% in 2018.

Automated Cell Counter Market: Products and Market Overview In the recent years, automated cell counters have become attractive alternative devices to manual cell counting devices. The greater demand for automated cell counters can be attributed to their accurate and reliable results in a fraction of the

time. Furthermore, these devices also significantly reduce manpower dependency and cell count variance. Several studies on the efficiency comparison of manual and automated cell counters have shown that latter provides improved cell counting reproducibility and accuracy.

Major players in the automated cell counter market are concentrating their efforts on research and development to introduce new products into the market, which are more cost-effective and affordable for small labs. In addition, several technological advancements in cell imaging technology are currently under process, which are likely to find applications in a wide range of clinical biomedical studies.

Macroeconomic indicators, such as favorable government policies for start-up companies for setting up manufacturing facilities, are estimated to fuel the growth of the automated cell counter market. Moreover, increase in the number of healthcare institutions and diagnostic centres is expected to boost the demand for automated cell counters. Furthermore, the growth of the healthcare sector in emerging nations is estimated to fuel the growth of the automated cell counters market. For instance, according to the World Bank Group, in 2014, Chinaâ&#x20AC;&#x2122;s healthcare expenditure was 5.5% of the GDP, and the countryâ&#x20AC;&#x2122;s healthcare expenditure is expected to double by 2020.

Automated Cell Counter Market: Segmentation

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Featured Article The automated cell counters market report offers a comprehensive taxonomy of the automated cell counters market based on product types, applications, end users, and regions.

Based on the product type, the global automated cell counter market is segmented into systems and reagents & accessories. The automated cell counter systems can be further classified into coulter counters, haemocytometers, flow cytometers, and image-based cell counters.

Based on application, the automated cell counter market is further classified into blood analysis, urine analysis, microbial cell count, cell-line viability, and others. With a wide range of applications and opportunities in the medical as well as research fields, the automated cell counters market offers significant potential for small and emerging players to invest in the market.

The automated cell counter market has been analysed across the regions of North America, Latin America, Europe, East Asia, South Asia, Oceania, and the Middle East & Africa.

Due to the high prevalence of HIV and the high incidence of cancer, various countries, such as India and China, as well as the North America region, are estimated to be the fastest-growing regional markets for automated cell counters, and are poised to offer significant opportunities. With a large number of ongoing cell-line research and cancer studies, the demand for automated cell counters is estimated to grow significantly in European countries as well.

Moreover, mergers & acquisitions and distribution & collaboration agreements by key manufacturers in the automated cell counter market are also among factors estimated to fuel the growth of the market.The automated cell counter market report tracks some of the key companies operating in the global automated cell counter market, which include Danaher Corporation, ChemoMetec A/S, F. Hoffmann-La Roche Ltd., Nexcelom Bioscience LLC, Oxford Optronix Ltd., ALIT Life Science Co., Ltd., Luminex Corporation, and Merck KGaA, among others.

These insights are based on a report on Automated Cell Counter Market by Persistence Market Research.

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Product Showcase

Uniaxial Powder Testing by Freeman Technology-a Micromeritics Company The Uniaxial Powder Tester (UPT) from Freeman Technology (a Micromeritics Company) is a unique stand-alone uniaxial shear tester for simple, sensitive and costeffective powder characterization.

The instrument delivers repeatable and reliable measurements, providing a robust alternative to traditional powder testing techniques.

Uniaxial testing first involves the construction of a consolidated powder column. This is then removed from its confining sleeve before being fractured through the application of a vertical stress, directly measuring the uniaxial Unconfined Yield Strength (uUYS). This

technique can therefore be used to assess and rank the flowability of powders.

Cohesive powders have relatively strong interparticulate forces, which encourage the particles to bond rather than move easily relative to one another. By contrast, in non-cohesive powders, the tensile forces between particles tend to be much weaker.

Uniaxial testing is a direct and reliable method for measuring the magnitude of this interparticulate strength, in the form of the uUYS (Ď&#x192;c) and Flow Function (FF).

The UPTâ&#x20AC;&#x2122;s level of automation and low operator input means the instrument delivers highly Repeatable data.

For more information: Apex Chromatography Pvt Ltd Plot No.35, Street No.3, Sagar Society, Banjara Hills, Hyderabad - 500 034 Email ID: rajiv.popat@apexchrom.com Mob: +91-9885031313

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Product Showcase

PCI Gas Flow meter for GC Flow Calibration / Validation High Performance Gas chromatography is an Important method used in Labs meant for doing Analysis of Samples to finding Impurities. Its done using modern GC devices form OEMâ&#x20AC;&#x2122;s worldwide. The Analysis Data is stored in comprehensive Database. Reports and

The observed readings are noted manually.

Shift from Manual to Automatic process â&#x20AC;&#x201C; Now the modern Labs are shifting from manual to Automatic Flow Calibration / Validation process using the GAS flow meter and Data Recording mechanism.

This consists of the serial Printer or Software. The printer prints only Flow value in numbers displayed on flow meter. No other details like Date, time, GC ID, User etc.

The Software Option to Record Data This is the best way to Record and Present Data in beautifully designed and formatted Reports.

The Analyst will do the Calibration / Validation work and send the Report to the Reviewer to check and verify. Both will sign the report and file it for future reference. This will be a document for Audit and Compliance purpose.

There are many benefits 1.

2.

3.

4.

5.

6.

7.

chromatograms are generated and stored on a daily basis.

The most important Parameter for any GC is the flow measured in mL/minute. Its accuracy is vital for any analysis. Therefore, there are stringent Flow calibration processes followed in Labs. Most follow a Quarterly or Half yearly manual Calibration process.

This is mostly done by Pressure Settings in GC Using Mano meter at input.

Only one or few readings are taken by User for each point of calibration

Achieve accurate results for Flow measurements For Various GC makes.

Authentic Data Records Compliance to norms USB COM Port For minute to Large flows Record Data and Generate Reports

For more information: PCi Analytics Pvt. Ltd. A-71, Road No. 22, Wagle Industrial Estate, Opp. Lodha Grandezza, Near Spraytech Circle, THANE (W)-400 604 (MS), INDIA TEL : +91-22-6831 93 93 Reception Mob;: +91-93237 00351 (9 AM to 7 PM IST) E-mail : info@pcianalytics.in URL : www.pcianalytics.in

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Product Showcase

Glassco Labs comes up with Dan Logitech Glassco a well know name in the field of laboratory equipment and the leading manufacturing companies in the field of scientific glassware from India, with a presence in over 83 countries across the World.

With all the experience and expertise in the field of manufacturing, Glassco Laboratory Instruments Pvt. Ltd has come up with Dan Logitech - The European Analytical Instruments Company with its Design house in Denmark and production house in India.

Dan Logitech is catering Scientists worldwide from Chemical, Pharmaceutical, Research & Development, Food & Environmental laboratories.

It makes Dan Logitech to manufacture European designed products at a cost effective price.

Today the company is one of the fastest growing manufacturer for analytical instruments, making it the most trusted and leaders in the sector of laboratory and industrial fluid handling products, instrumentation, and equipment. Have supplied by the name of Glassco Laboratory Instruments Pvt Ltd and now Dan Logitech in the market worldwide. With products for heating, mixing, crushing and distilling applications used by the top development houses and laboratories.

Dan Logitech is committed to provide Innovative, Customized and Adaptive equipment with Danish Design and Indian Engineering to be applied in various laboratories, universities, research centers and companies involved in scientific research from small to very large enterprises.

Since its inception in year 2014 Dan Logitech has grown many fold with its presence in more than 27 countries worldwide, through company-owned customer channel outlets, a strong network of international dealers and have a wide customer base worldwide.

With its products with ISO and UL certification Dan Logitech has an excellent position in the international market.

Dan Logitech has employed high performing teams of trained and experienced engineers from the premium institutes who strive to exceed customerâ&#x20AC;&#x2122;s expectations every day to deliver the best of the industry instruments.

Here team works to get the best products made with a lot of R&D and testing to provide the most costeffective and time bound solutions.

Making their products to deliver high performance with high accuracy at great reliability.

With all this said their products provide accuracy, convenience and comfort to conduct safe and efficient experiments. Dan Logitech is focused to develop and provide customized products that fits all end user applications.

Dan Logitech is preferred by the customers for their exceptional service and technical support and highly responsive customer service.

After a lot of demand from the market for a Software to manage the instruments Dan Logitech has come up with Labs-ConnectTM, A Wi-Fi Based Technology that enables the operator to operate the instruments from remote locations.

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Product Showcase Labs-ConnectTM is a Free Technology for helping the research community to carry out multiple experiments at low cost infrastructure to save time for the development of life saving drugs & experiments. Labs-ConnectTM helps making Smart Labs by Saving Money, Time & Paper. Thus allows researcher to draw log chart perform Quick Analysis and thereby Enhancing R&D by Sharing workload at secured platforms.

Points that make Dan Logitech a step ahead from others.

Logical Functions: Integrated features like Heating, Steering, Time, Alarm etc.

Hi-tech Programmable Models: Free LabsConnect to control Wi-Fi enabled Dan-Logitech Instruments remotely.

Easy & Innovative UI: World's first company to provide plate/prop, toggle, Jog Dial for single hand operations and to inbuilt globalized features as C/F.

Affordable Technology: Now get a high quality value product with 3 years warranty with technical support and excellent services.

Customized Products: They also do OEM for their esteemed customers in USA, Europe and Asia.

Sustainable Design: All their instruments speak same design language and UI, So becoming used to it is unavoidable.

1. Their world class European instruments: 2. Are ISO and UL Certified 3. Used by top development houses.

4. Innovative, Customized and Adaptive.

5. Provides high convenience & comfort.

6. Fits all end user applications.

7. The best made with extensive R&D. 8. Deliver high performance with accuracy 9. Danish Design & Indian Engineering.

For more information: GLASSCO LABORATORY EQUIPMENTS PVT. LTD. MANGLAI P.O. KUDDA KALAN, AMBALA CANTT â&#x20AC;&#x201C; 133004 (INDIA) PH: 0091-171-7082015113, 7082015114

customercare@glasscolabs.com

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Product Showcase

Ultrasonic Flowmeters Help Reduce Drug Production Costs Titan Enterprises reports that its Atrato and

The Metraflow ultrasonic flowmeter was designed for customers tasked with applications that pose fluid compatibility challenges. Using patented ultrasonic technology, with a single unbroken PFA measurement tube, the MetraFlow is able to reliably operate with excellent accuracy across flow ranges from 20 to 5000 ml/min, having excellent turndown of 50:1; repeatability (+/– 0.1%); linearity and a reading accuracy of better than +/– 0.5% full scale.

For further information please visit contact Titan Enterprises on +44-1935812790 / sales@flowmeters.co.uk.

MetraFlow ultrasonic inline flowmeters are used by drug manufacturers to streamline production and reduce costs. These devices measure a liquid’s rate of flow with extraordinary levels of accuracy, helping drug manufacturers control small details that make a big difference during production.

Production of pharmaceutical drugs presents difficult challenges for process instrumentation used to monitor and optimise the process. Typically drug production processes require devices able to cope with low flow rates and constructed from ultra-pure materials so as to maintain hygienic, sterile and sanitary conditions.

The Atrato range of inline low flow flowmeters use patented ultrasonic technology, which enables it to operate with excellent accuracy over a very wide flow range (0.002 to 20 litres/ minute). The rugged, clean bore construction makes the Atrato ideal for almost any low flow application. Different models of this non-invasive flow measurement device are available for metering fluid flow from -10°C to +110°C and pressures up to 30 bar (435 psi).

Drawing upon over 40years of flowmeter innovation Titan Enterprises Ltd are a manufacturer of highperformance solutions including the Atrato ultrasonic flowmeter, Oval Gear flowmeters, low flow Turbine flow meters and a flow instrument range. Titan’s company philosophy of “pushing the envelope by trying to do things a little different and better” has resulted in sales of over 500,000 products into 50 countries worldwide and a repeat purchase percentage of 95%. All flow meters produced by Titan Enterprises are designed and manufactured to ISO9001 and calibrated to an uncertainty of ±0.25%.

For more information:

Titan Enterprises Ltd. Coldharbour Business Park Sherborne,Dorset DT9 4JW,UK tel. +44-1935-812790 email sales@flowmeters.co.uk www.flowmeters.co.uk

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Product Showcase

2D Barcoded Tubes for Sample Storage at Ultra-Low Temperatures

The Ziath range of CryzoTraq™ 2D-barcoded cryogenic tubes set a new standard for cryogenic storage of biological specimens at temperatures as low as 196°C. Worldwide biobanks and biorepositories support many types of life science research including Genomics and Personalized Medicine. To ensure the integrity and viability of specimens stored in these sample storage facilities over long periods of time, the specimens are placed in a sterile storage tubes and immersed in vapor phase Liquid Nitrogen. Leak-free cryogenic tubes are therefore of utmost importance to ensure sample integrity.

Produced using an innovative 2-stage injection molding process the caps on CryzoTraq™ tubes deliver outstanding leak resistance. This high integrity closure on CryzoTraq™ tubes ensures that sample cannot leak out and conversely that no contaminants can enter the tube. This is vitally important because if the specimen is contaminated, it is rendered useless for further research.

To ensure full sample traceability, all CryzoTraq™ tubes have a 2D datamatrix barcode inserted in the base of the tube. The insert is secured in place by the use of ultrasound to weld it into place.

During this manufacturing process, a linear barcode is printed onto the side of the tube first, and the 2D code is automatically generated from the linear barcode therefore ensuring the two barcodes will always be the same with no errors.

CryzoTraq™ tubes are manufactured in accordance with ISO 13485:2003, in compliance with ISO 14644 and 14698 (Federal Standard 209) and in a Class 7 cleanroom (Class 10,000). Available in 2ml and 5ml volumes, CryzoTraq™ tubes are certified free from DNA, DNase, RNase, pyrogens and ATP. Each lot is sterilized with electron beam radiation.

CryzoTraq™ tubes are manufactured from medical grade polypropylene and the caps from medical grade polyethylene.

To enable fast and precise decoding of the 2D-barcodes on CryzoTraq™ tubes Ziath offers its affordable, high performance DataPaq™ Multirack and Cube scanners.

For further information on CryzoTraq™ 2D-barcoded cryogenic tubes please visit www.ziath.com/index.php/products/tubes/cryzotraqtubes-and-racks or contact Ziath on +44-1223-855021 / +1-858-880-6920 / info@ziath.com.

Founded in 2005, Ziath specialises in development of innovative instrumentation control and information management products using 2D DataMatrix bar-coded tubes to simplify automation processes in life science organisations, from academia, to the biotech and pharma industries. For further information please visit www.ziath.com

For more information: Ziath Ltd Unit 2a, Solopark Trading Estate Station Road Papisford Cambridge CB22 3HB UK Tel: +44 1223 855021 Email: info@ziath.com Web www.ziath.com

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Product Showcase

Porvair Secures Major Contract for Pipette Tip Filters Porvair Sciences has developed a new range of filters for pipette tips for a leading separation science supplier who was looking to bring control of supply and manufacture of these components in house.

fully compliant with FDA, USP Class VI and European Pharmacopoeia statutory regulations as well as being free from heavy metals. The unique combination of these ultra-clean materials, with excellent porosity properties, has produced a highly reproducible filtered pipette tip with an excellent edge finish that always provides an optimum fit into the pipette tip enabling labs to routinely achieve superior liquid handling and dispensing.

For further information please visit https://www.vyonporousplastics.com/pipette-tipfilters/. To discuss OEM development of high performance porous plastic components for filtering or separation applications please contact Porvair Sciences Ltd on +44-1978-661144 or enquiries@porvairsciences.com.

Porvair Sciences are global leaders and original manufacturers and developers of cutting-edge porous plastics technologies. With patents dating back to the 1950â&#x20AC;&#x2122;s, our porous plastics continue to evolve, adapt and respond to changes in

Initially Porvair Sciences undertook testing to fully characterise (air flow, pore size, material make-up) the outsourced pipette tip filters the customer sought to replace.

Then working closely with an injection moulding company who were reverse engineering the pipette tip itself, Porvair Sciences developed a highperformance pipette tip filter based upon their proprietary VyonÂŽ porous plastic.

Following a lengthy competitive evaluation of filtered pipette tips from a number of different suppliers the customer elected to go with Porvair Sciences. This decision has enabled the customer to both improve upon their existing product as well as bringing control of supply and manufacture in house.

Benefitting from Porvair Sciences proprietary VyonÂŽ porous plastics, the pipette tip filters are

technologies, markets and customer needs.

Empowered by 50 years of industrial experience, we strive to continue delivering world class, high performing products while providing superior customer service, every step of the way. Our diverse team of scientists, engineers and creative thinkers are committed to providing expert solutions that brings value and integrity to our customers.

For more information: Porvair Sciences Ltd Clywedog Rd South Wrexham Industrial Estate Wales LL13 9XS UK Tel: +44 1978 661144 Email: int.sales@porvair-sciences.com Web www.porvair-sciences.com Media Dr Bill Bradbury Primetek Solutions +44-208-546-0869 / info@primetek-solutions.com

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Product Showcase

Sartorius Stedim Biotech Launches New Sartocheck® 5 Plus Filter Tester Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has announced the launch of its new Sartocheck® 5 Plus filter integrity tester.

Designed for use in downstream processing, this new integrity tester is the latest development in the established line of Sartocheck® units already recognized throughout the pharmaceutical

industry. Based on extensive research of customers’ needs to confirm the integrity of filters in pharmaceutical production, Sartocheck® 5 Plus features the most advanced functions for ensuring maximum data integrity and compliance with future requirements of quality risk management, such as the upcoming Annex 1 of the European Medicines Agency (EMA).

The new filter tester greatly improves the detectability of operator errors, improper test setups and out-of-tolerance environmental conditions. It is also more reliable and easier to use than ever before. With the Sartocheck® 5 Plus,

false passed and false failed test results are therefore relegated to the past.

Where other devices are limited in their flow measurement capability, this advanced filter tester has been designed to cover the complete range of integrity testing from small syringe filters up to large multi-round housings and crossflow cassettes, with diffusion rates of up to thousands of milliliters per minute.

In addition, the automatic test time feature for diffusion and water intrusion, along with accelerated bubble point testing, reduces overall test time. Parallel bubble point testing is also a significant time saver as this function enables up to 10 small filters to be checked with one Sartocheck® 5 Plus.

User benefits include the biggest and brightest screen currently available on the market (12”) for integrity testers, along with an ergonomic interface, an easy-to-clean design, improved data integrity and inherent virus protection. Sartocheck® 5 Plus is also the only integrity tester that is ATEX | IECEx | FM compliant. It protects operators by allowing safe integrity testing of alcohol-wetted filters. To prevent crosscontamination, the device can be used together with an accessory kit for external venting.

The filter integrity tester comes with comprehensive quality risk management documentation, including an FMEA (Failure Mode and Effects Analysis).

Qualification protocols are available and operational qualification can be performed by SSB’s Service team for maximum security and peace of mind. The company also provides on-site annual or biannual calibration along with preventive maintenance.

The Sartocheck® 5 Plus is set to become the new reference standard for filter integrity testing. The purchase of this device includes a pre-established roadmap of software upgrades that come with comprehensive risk assessments. Add-on features do not require re-qualification.

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Product Showcase The software upgrades include valuable patented and patent-pending features for the highest data integrity, QRM, HSE and usability, throughout the entire life cycle of the filter integrity tester.

Story source: Sartorius Stedim Biotech

Eppendorf CryoCube® F101h ULT freezer: Compact green -80°C

Hamilton Launches Robotics Consumables E-Commerce in U.S. and Canada

Eppendorf reached a further milestone of sustainability by re-designing the compact ultra-low temperature (ULT) freezer CryoCube F101h (230 V) on future-proof green cooling liquids and green insulation foam.

Convenient Online Ordering of CORE® Tips, Tubes, Reagent Containers and More Hamilton announces the launch of a new ecommerce tool designed to facilitate convenient ordering of consumables used on all Hamilton

By combining longevity and quality with sustainability aspects, the CryoCube F101h is the personal below-the-bench ULT freezer. 101 L of 80°C can be filled with up to 60 freezer storage boxes. Compared to its precursor, the F101h saves up to 17% of power.

automated liquid handling and robotic platforms, including their broad array of specialized assay ready workstations.

Customers in the United States and Canada can register at the website Once set-up, customers can view personalized account information including review of past orders, and easily select from over 120 consumable products including Compressed O-Ring Expansion (CO-RE®) tips that create a lock-and-key fit with each pipetting channel to ensure a tight seal with precise tip positioning while preventing aerosol generation during ejection. Additional consumable products include unique tube-in-tube AutoLys tubes, automation-friendly FlipTube microtubes, reagent containers and much more.

Story source: Hamilton Company

This is a further building block in a longer green Eppendorf story. Eppendorf now has more than 10 years of experience in research and development, production, logistics, and service in the field of green ULT freezers.The CryoCube F101h, the new members of the CryoCube F740 series, VisioNize® user interface and lab connectivity applications as well as the eLABInventory sample management software are further new building blocks for a smart cryosolution of valuable samples.

Story source: Eppendorf AG

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Product Showcase

Thermo Fisher Scientific Collaborates with Owlstone Medical to Advance the Identification of Novel Biomarkers Thermo Fisher Scientific Orbitrap GC-MS technology to be integrated into Breath Biopsy to support identification of novel biomarkers for early disease detection.

Thermo Fisher Scientific, the world leader in serving science, and Owlstone Medical, the global leader in Breath Biopsy for applications in early disease detection and precision medicine, have entered into a collaborative partnership to advance the early diagnosis of cancer and other diseases through the discovery and validation of novel biomarkers by non-invasive breath sampling.

Through the integration of leading Orbitrap gas chromatography mass spectrometry (GC-MS) instrumentation into Owlstone Medical’s Breath

Biopsy platform, the collaboration will qualify Thermo Fisher’s mass analyzers for the detection of new biomarkers via a validated discovery and routine analysis project. Developed in partnership, the new analytical methods will be used to conduct metabolomics studies of breath samples for unique biomarkers that could translate into non-invasive, routine screening solutions for improved early diagnosis of cancer and other disease.

"There is a growing need for non-invasive diagnostic solutions to support early disease detection, patient treatment and increase remission rates," said Morten Bern, director of marketing, gas chromatography, Thermo Fisher Scientific.

"The combination of our Orbitrap GC-MS technology with Owlstone Medical’s Breath Biopsy platform provides a unique basis to improve patient outcomes through the discovery of novel biomarkers and their incorporation into research use and clinical tests."

Billy Boyle, co-founder and chief executive officer at Owlstone Medical, said: "The Orbitrap platform’s ability to detect a wide range of chemicals during targeted and untargeted analyses without losing selectivity or sensitivity, promises to be of substantial benefit to our Breath Biopsy platform. With a large and rapidly expanding installed base of GC Orbitrap systems, our collaboration with Thermo Fisher Scientific represents an exciting opportunity for crosspromotion of the platform and technique, by which the benefits of Breath Biopsy can be broadly realized."

Story source: Thermo Fisher Scientific

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PUBLISHED ON: 20th November 2019 RNI NUMBER: UPENG/2017/73675