Tuesday, August 28, 2018 Daily Archives

Accelerating Biopharmaceutical Development with High-Throughput Glycan Screening and Multiple Attribute Methodology

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Part 1 Development of biopharmaceuticals comprises many integrated steps, beginning with research and discovery and optimally ending with a commercial therapeutic molecule. Early screening of large numbers of clones and cell culture expression conditions is essential to identifying proteins that carry to greatest likelihood of clinical and commercial success. Part one of this report reviews how high-throughput glycan screening can significantly improve current analytical strategies relating to cell line development. Part 2 Minor impurities and changes in attributes such as…

August 28, 2018

Optimizing Unit Operations In Biopharmaceutical Manufacturing

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There are many critical material-handling challenges regarding flow rates, pressure levels and the prevention of shear in the chromatography, virus filtration and TFF processes that are used in the manufacture of biopharmaceuticals. In order for these unique operations to be implemented successfully while handling fluids that can be sensitive, delicate and expensive, the operator must be aware of their specific operating characteristics and choose a pumping technology that can meet the strict demands for successful operation. While lobe and peristaltic…

August 28, 2018

Novartis constructing $92m CAR-T plant as Kymriah arrives in EU

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Up to 450 jobs will be created as Novartis commits to a production site for cell and gene therapies in Switzerland. The investment will support CAR-T drug Kymriah, which received European approval this week. A year after the US Food and Drug Admistration (FDA) approved Kymriah (tisagenlecleucel), the European Commission (EC) has granted the Novartis’ therapy approval to treat B-cell acute lymphoblastic leukemia (ALL). In the US, the chimeric antigen receptor T cell (CAR-T) product is manufactured at Novartis’ Morris…

August 28, 2018

Bioreactors from Ireland to China: ABEC gains second license

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ABEC has received approval to supply bioprocessing equipment to China from its facility in Kells, Ireland. Bioreactor and bioproduction equipment vendor ABEC has been supplying the Chinese market for the best part of a decade, after its Springfield, Missouri facility obtained a China Manufacture License (CML) in 2010. Now the firm can supply its tech from a second facility, the Kells plant in County Meath, Ireland, after the government granted the plant a China Manufacture License (CML) to manufacture pressure…

August 28, 2018