Wednesday, June 15, 2022 Daily Archives

Rentschler says FDA has closed out 483 at Germany plant

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Observations made by an FDA inspection in February at Rentschler’s site in Laupheim have been fully resolved, says Rentschler Biopharma. This week, the US Food and Drug Administration (FDA) published results from an inspection at contract development and manufacturing organization (CDMO) Rentschler’s drug substance manufacturing site in Laupheim, Germany carried out in February. The heavily-redacted Form 483 noted nine observations at the facility, with issues including failures to assure compliance with established specifications and standards in laboratory procedures, problems with…

June 15, 2022

Bridging Anti-CHO HCP Antibodies From Two Third Generation Cygnus CHO HCP ELISA Kits by AAE-MS™

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This webcast features: Eric Bishop, Vice President, Research & Development, Cygnus Technologies. A well-developed, broadly reactive, and qualified HCP ELISA remains a gold standard method effectively used during the purification process to ensure removal of HCP and to demonstrate process consistency and final drug substance purity. Regulatory guidelines require that sponsors use orthogonal methods for demonstrating antibody coverage to individual HCPs and provide a comprehensive assay qualification package to ensure the HCP ELISA is fit for purpose. In this presentation,…

June 15, 2022

Avid doubles mammalian capacity with $6m investment

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Avid Bioservices says the expansion of its laboratories could support a further $20 million in annual process development revenue, doubling its current capacity. Contract development manufacturing organization (CDMO) Avid says it is not specifying what facility the expansion will take place at but did confirm it will be located on the firm’s main campus in Tustin, California. “The company is expanding to keep up with market demand for these CDMO services. Avid is focused on ensuring that it always has…

June 15, 2022

Charles River and ASC partner to manufacture gene therapy

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Charles River Laboratories and ASC Therapeutics have partnered to manufacture ASC618, a second-generation gene therapy that aims to treat hemophilia A. The agreement builds upon the firm’s relationship initiated in 2019 where ASC collaborated with Charles River (previously operating as Vigene Bisosciences prior to the acquisition last May) to use the contract development manufacturing organization’s (CDMOs) processes for adeno-associated virus (AAV) production and purification. According to Charles River, together the firms have established a high-yield upstream process for AAV8 production,…

June 15, 2022