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

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

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

Do you know if Nova Biomedical offers an on-line sampling option for their Flex 2 instrument?

This past December Nova Biomedical introduced their on-line auto sampling solution for the BioProfile Flex 2 known as the OLS. You would likely have seen this solution featured at numerous industry events in recent months if not for the challenges posed by COVID-19. While several firms offer a solution for automated sampling from the Flex 2, most notably Flownamics, the OLS is the only sampling solution that is native to Nova. I have provided a link below to more information.

FLEX2 On-Line Autosampler (OLS)

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

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.

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Key Components of Proteins are Twisted to Boost Reactions Useful to Medicine

In proteins, amino acids are held together by amide bonds. These bonds are long-lived and are robust against changes in temperature, acidity or alkalinity. Certain medicines make use of reactions involving amide bonds, but the bonds are so strong they actually slow down reactions, impeding the effectiveness of the medicines. Researchers have now devised a way to modify amide bonds with a twist to their chemical structure that speeds up reactions by 14 times. This could be of great benefit to various medical researchers in the fields of drug development and more. Learn More

Microparticles for Cell Disruption and/or Biomolecule Recovery

A U.S. Patent for "Microparticles for Cell Disruption and/or Biomolecule Recovery" was awarded to Boehringer Ingelheim on May 26th, 2020. The present invention is a method of manufacturing a protein of interest comprising: (a) cultivating a host cell that produces the protein of interest in a biological fluid; and (b) recovering the protein of interest from the biological fluid by: (i) adding to the biological fluid positively-charged microparticles comprising a ground polymeric anion exchange resin or negatively-charged microparticles comprising a ground polymeric cation exchange resin, and (ii) recovering the proteins of interest from the biological fluid... Learn More

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

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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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

Takara Bio Acquires Two Buildings in San Jose, California

Takara Bio has bought two buildings totaling 129,000 sq. ft. from the University of California Regents. The company will shift its local headquarters from Mountain View, where it currently is a tenant, to the pair of north San Jose buildings. Takara paid $44.8 million for the two buildings, according to property documents filed with county officials on May 12th. The two properties, located at 2560 and 2570 Orchard Parkway are part of the four-building Valley Research Center, near the corner of Orchard Parkway and West Trimble Road and just down the block from North First Street and its light rail lines. The deal appears to position Takara for a significant expansion. Learn More

Manta Rays Have the Largest Brain of All Fish

They show signs of recognizing themselves in the mirror and may be self-aware. Learn More