Thursday, September 2, 2021 Daily Archives

How Eurofins Applies Rapid Methods to Support Autologous Cell Therapies

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Autologous Cell Therapies are an advancement in personalized medicine using a person’s own cells to effectively treat a disease. Due to the immediate nature required for returning the cells to patients, rapid biosafety testing approaches must be utilized to demonstrate the cells have not been contaminated during cellular processing. Eurofins BioPharma Product Testing provides GMP-validated biosafety assays to test for the presence of microbial, mycoplasma, and endotoxin contaminations in less than half the time of the traditional methods. Eurofins’ GMP…

September 2, 2021

COVID-19 boosters set to bolster life sciences services firms

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With booster shots on the agenda, large life sciences vendors and contract manufacturers are likely to see the COVID-19 windfall continue for the foreseeable future. It has only been nine months since vaccines began being rolled out to combat COVID-19, but some countries are now administering, or planning to administer, third shots to vulnerable patients. Nearly a million Americans have already received a booster shot, while a third dose of Pfizer/BioNTech’s vaccine is becoming part and parcel of Israel’s immunization…

September 2, 2021

FDA: Drug firms using 24/7 production need more viral safety data

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The US FDA has urged protein therapeutics makers using continuous manufacturing to take steps to keep products virus free. The regulator made the suggestion in a recent concept paper along with more general advice on how industry can use 24/7 production to manufacture protein drugs more efficiently. Viral contamination is an issue for all biopharmaceuticals made in processes that use mammalian cell lines. The cells contain sequences that can produce potentially harmful virus-like particles that must be removed from the…

September 2, 2021