Tuesday, May 2, 2023 Daily Archives

Purpose-Built Viral-Vector Facility Construction: Applying Quality and Engineering Controls

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In this report, Avid shares its approach to producing high-quality, safe, and effective viral vectors for use in gene therapy and vaccine applications. The company is dedicated to minimizing the risks for, and associated high costs of cross-contamination and contamination during manufacture of viral-vector products. To this end, the contract development and manufacturing organization (CDMO) is establishing a rigorous quality control program as it completes its new facility. In 2021, Avid began building a 53,000-ft2 site in Costa Mesa, CA,…

May 2, 2023

European CGT sector falling behind US and Asia

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Europe’s cell and gene therapy sector has stagnated but advocacy group the Alliance for Regenerative Medicine (ARM) hopes upcoming legislation can reinvigorate the sector. In many areas of pharma, Europe has been at the forefront. The continent approved biosimilars, for example, nearly a decade before the US. And for cell and gene therapies (CGTs), the European Medicines Agency (EMA) has often given the green light ahead of their regulatory counterparts across the globe. For example in 2022, Europe approved both…

May 2, 2023

‘Better together’ – Danaher completes Cytiva Pall merger

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Bringing the Pall portfolio under the Cytiva brand will bring customers simpler and greater access to bioprocess technologies and services, claims Danaher. Danaher Corporation jumped into the pure-play bioprocess space in 2015 buying the life sciences business of Pall Corporation for $13.8 billion. Five years later, the firm doubled down on the sector paying $21 billion for Cytiva (then known as GE Healthcare Life Sciences). While the two have been operating as separate brands, going forward both will fall under…

May 2, 2023