BioPharma Leaders Shoot Down WHO Voluntary Pool for Patent Rights on Covid-19 Products

                                                                                          Issue # 3209 | May 29th, 2020      




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News Alert

   

BioPharma Leaders Shoot Down WHO Voluntary Pool for Patent Rights on Covid-19 Products

The heads of some of the world's largest drug makers expressed a mix of confusion and resistance to a WHO voluntary pool to collect patent rights, regulatory test data, and other information that could be shared for developing Covid-19 therapies, vaccines, and diagnostics. The WHO effort reflects mounting concern that some Covid-19 medical products may not be accessible for poorer populations. By establishing a voluntary mechanism, the goal is to establish a pathway that will attract numerous governments, as well as industry, universities and nonprofit organizations. But not every executive likes the idea. Learn More
 


FDA Finds Carcinogen in Some Versions of Popular Diabetes Drug

U.S. regulators are contacting biopharma companies that make a popular diabetes medication after some of the pills were found to contain high levels of a chemical that can cause cancer. The U.S. FDA discovered N-Nitrosodimethylamine, or NDMA, beyond acceptable amounts in some extended-release versions of metformin, Sarah Peddicord, an agency spokeswoman, said in a statement to Bloomberg. Some metformin recalls are expected as soon as this weekend, though it wasn't clear which companies were planning to remove their products from pharmacy shelves, according to a person familiar with the matter. Metformin is manufactured for the U.S. market by numerous generic drugmakers worldwide. Learn More



Thermo Fisher and CSL Enter Strategic Partnership

Thermo Fisher Scientific and CSL have announced a strategic partnership to help meet the growing demand for biologic therapies while also accelerating CSL's broader manufacturing objectives. Thermo Fisher will support CSL's product portfolio by leveraging its pharma services network, including drug product development, biologics manufacturing, sterile fill-finish, packaging and clinical trials logistics. Through a long-term lease agreement with CSL, Thermo Fisher will operate a new state-of-the-art biologics manufacturing facility in Lengnau, Switzerland, when construction is completed in mid-2021. Learn More

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On this Day Alert

1953  Edmund Hillary and Tenzing Norgay Reach
          Everest Summit 



On this day in 1953, Edmund Hillary of New Zealand and Tenzing Norgay, a Sherpa of Nepal, become the first explorers to reach the summit of Mount Everest, which at 29,035 feet above sea level is the highest point on earth. The two, part of a British expedition, made their final assault on the summit after spending a fitful night at 27,900 feet. News of their achievement broke around the world on June 2, the day of Queen Elizabeth II's coronation, and Britons hailed it as a good omen for their country's future. Learn More

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TED Alert

What Happens in Your Brain When You Taste Food


With fascinating research and hilarious anecdotes, neuroscientist Camilla Arndal Andersen takes us into the lab where she studies people's sense of taste via brain scans. She reveals surprising insights about the way our brains subconsciously experience food -- and shows how this data could help us eat healthier without sacrificing taste. Learn More

Poll Alert

Based on what you have read, seen, or heard about the death of George Floyd in a police-involved incident, should the officer responsible for his death be arrested?

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Bioprocess Alert

Anti-COVID-19 Biologics - Using the BioPhorum Standard MAb Process to Estimate Required Manufacturing Infrastructure, Investment and Resulting Drug Cost

 
  
What would it take to rapidly manufacture 3 metric tonnes and then 10 metric tonnes of a mAb? Optimized product development procedures to speed up the transition of a discovered mAb into clinic and into commercialization have been discussed in an excellent article by Brian Kelley. What about subsequent commercial manufacturing capacity? According to Ecker and Seymour, 23 metric tons of approved biologics were produced in 2018, with 65% of that capacity controlled by 10 companies. Squeezing an extra 10% of the global capacity out of the network seems achievable, particularly if these top 10 companies are involved. We used Biosolve Process to estimate the current manufacturing capacity and timeframes for production of these products. Learn More
 
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Webinar:  T-Cell Expansion in Single-Use Bioreactors

Wednesday, June 3rd, 2020

Presented by Vincent Wiegman, University College London

The recent clinical success of several CAR-T cell therapies has led to a rise in research endeavours into every part of their manufacturing. Timelines are critical and the final product is extremely high in value, which emphasises the need for an efficient and dependable process. This webinar shows how the micro-Matrix system can be used to optimise the environmental conditions of the T Cell expansion step and it explores the impact of varying CO2  conditions on T Cell proliferation in single-use stirred miniature bioreactor systems.

Resource Alert

Automated Buffer Preparation Using Quaternary Valve in Fast Performance Liquid Chromatography for Protein Purification from a Cell Membrane

 

There is a great need for high-throughput protein purification to produce protein molecules for research and therapeutics. Although there have been significant advancements made in automated multi-step chromatography and preparative in-process design-of-experiment (DOE) capabilities in commercial fast performance liquid chromatography (FPLC) instruments, almost all commercial FPLCs rely on a binary buffer mixing system, which hinders automated buffer preparation. Nevertheless, current-generation FPLCs are equipped with a quaternary mixer designed for limited in-line buffer preparation and preparative pH scouting DOE experiments. We decided to leverage the quaternary mixing capability by extending and re-programming AkTA Avant's quaternary valve into an automated in-process buffer preparation system to simplify automated purification requiring complex washing steps. Learn More

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Regulatory Alert



EMA Explains GMP and GDP Flexibilities Amid COVID-19

The EMA and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, adding a new section laying out temporary flexibilities for good manufacturing practice (GMP) and good distribution practice (GDP). Specifically, the guidance lays out four questions and answers pertaining to GMP flexibilities and three questions and answers on GDP flexibilities, as well as a new section on the suspension of on-site inspections of plasma collection centers. Learn More

Discovery Alert