Thursday, March 31, 2022 Daily Archives

eBook: Potency Bioassays — Development, Trending,
Transfer, and Automation

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Bioassay development is a complex process that must be undertaken with great rigor and attention to detail. Potency testing experts use a range of methods including cell-based and binding assays. Consistency and reliability of results over time are paramount. Well-developed and -characterized methods are the end result of much phase-appropriate development work that goes on in parallel with bioprocess and biotherapeutic product development. This eBook begins with BPI senior technical editor Cheryl Scott’s report from the Biopharmaceutical Emerging Best Practices…

March 31, 2022

UK reports 9% yearly growth in CGT clinical trials

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CGT Catapult says the UK is a “world leader†in developing advanced therapies after publishing a 2021 clinical trials database and report. The Cell and Gene Therapy Catapult (CGT Catapult) says its Advanced Therapy Medicinal Product (ATMP) 2021 clinical trials report has highlighted a period of continued growth in both the amount and progress of trials being conducted in the UK. “In the UK, just under 80% of ATMP clinical trials are commercially sponsored, an increase of 13% over the…

March 31, 2022

Vetter and Rentschler double down on CDMO collaboration

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Having originally teamed up in 2020, the two CDMOs have rebranded their combined drug substance and fill/finish service offering under the ‘Xpert Alliance’ umbrella. The German contract development and manufacturing organizations (CDMOs) formed a strategic alliance in July 2020 to offer customers Rentschler’s drug substance manufacturing capacity in combination with Vetter’s aseptic fill and finish and secondary packaging services. Nearly two years on, and the partnership has been formalized further through the creation of the ‘Xpert Alliance’ brand; a “visualization…

March 31, 2022