Friday, April 30, 2021 Daily Archives

eBook: Bioreactor Sensors —
Inside the Dynamics of Cell Culture

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Cell culture monitoring can fall into something like a “black box” conundrum. Efforts to measure key parameters such as pH, glucose, and even cell density require sampling and removal of the contents from a bioreactor. But that procedure can expose both a process and an operator to contamination risks. Emerging bioreactor sensors are designed to address some of those challenges, but the rapid adoption of single-use technologies and the rise of perfusion cell culture have presented obstacles to their implementation.…

April 30, 2021

Automation of a Next-Generation Sequencing Method for Cell Line Species Identity

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This webcast features: Dr. Christine Mitchell, Scientific Fellow, Analytical Development, WuXi Advanced Therapies As the gene and cell therapy market continues to expand, affordability and accelerated turnaround time (TAT) become increasingly important in the industry. Despite the escalating diversity of therapeutic modalities, the criticality of a robust cell bank remains a pivotal starting point for many biological products. The integrity of species identity for cell lines is a critical quality attribute for many cell and gene therapies, and with regulatory…

April 30, 2021

Emergent recognized cross contamination risk at Bayview plant hit with 483

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Emergent BioSolutions has defended the manufacture of two different viral products from its Bayview facility as part of the “Herculean task†of tackling the coronavirus pandemic. The Bayview, Maryland drug substance facility has been on the forefront of the fight against COVID-19, with Emergent BioSolutions contracted to make millions of doses of Johnson & Johnson and AstraZeneca’s respective vaccines from the plant. But an ingredient mix up reported in March rendered 15 million doses unusable, and Emergent has now halted…

April 30, 2021

Samsung Biologics and TG Therapeutics expand mAb manufacturing contract

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Samsung Biologics and TG therapeutics have expanded their existing contract to manufacture Ublituximab, a monoclonal antibody drug to treat multiple sclerosis.  Korean Contract development manufacturing organization (CDMO) Samsung Biologics and US-based firm TG Therapeutics have expanded their 2018 contract to produce TG’s ublituximab (TG-1101), a monoclonal antibody (mAb) that targets an epitope on CD20-expressing B-cells. Samsung Biologics did not divulge ublituximab’s manufacturing process due to client confidentiality. However, a spokeswoman for the firm told BioProcess Insider it will “offer large-scale…

April 30, 2021