Tuesday, February 8, 2022 Daily Archives

Lonza cites RealHope to improve DP services

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Lonza’s drug product services division is participating in the RealHope project to establish challenges that contribute to protein instability during the handling process. The Real-World Handing of Protein Drugs – Exploration, Evaluation and Education (RealHOPE) project aims to destabilize protein-based therapeutics by measuring real-life events during drug handling to significantly improve the safety and effectiveness of the drug development process. According to Swiss contract development manufacturing organization (CDMO) Lonza, assessing protein stability is required to ensure process optimization and the…

February 8, 2022

WuXi Bio: COVID-delayed inspections blamed for addition to US Unverified List

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The addition of two WuXi Biologics sites to the US Government’s Unverified List will have no impact on its business, the CDMO says. On Monday, the US Commerce Department added 33 Chinese companies to its Unverified List (UVL) including two subsidiaries of contract development and manufacturing organization (CDMO) WuXi Biologics based in Shanghai and Wuxi. As supply chain consultants BDP put it: “The UVL lists names of companies that the Bureau of Industry Security (BIS) could not verify as bona…

February 8, 2022

Cell and gene sector needs regulatory clarity says Andelyn

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Cell and gene therapy developers are still uncertain of regulator expectations according to Andelyn Biosciences, which says industry would benefit from more balanced oversight. Various agencies have invested a lot of effort in the development of regulatory frameworks for cell and gene therapy development and manufacture. Recent examples include the US FDA’s draft guidance on trialing multiple versions of a cell therapy and the EMA’s document on quality expectations for products containing genetically modified cells. While these efforts are a…

February 8, 2022