Friday, May 6, 2022 Daily Archives

Cold Chain Excellence: Getting Control Over Freezing of Biologics

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HOW CONTROLLED FREEZING ENABLES SCALABILITY: Controlling the freezing behavior of drug substance is the ultimate goal in pharmaceutical manufacturing. It opens doors to process reproducibility, consistent quality of the final drug product by maintaining uniform conditions for the biopharmaceuticals during freezing and consequently for frozen storage and shipment. As one of the most essential parameters to achieve control over freezing & thawing bulk, the freezing rate has been considered and evaluated in different tests. The leverage of the ice front…

May 6, 2022

Coherus: FDA calls for quality process change in toripalimab CRL

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Coherus and partner Junshi will resubmit the BLA for toripalimab by mid-summer after the US FDA requested a quality process change. Coherus BioSciences announced this week itself and partner Junshi Biosciences received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its metastatic nasopharyngeal carcinoma (NPC) candidate toripalimab. Toripalimab was first approved in China to treat melanoma in 2018, but Coherus acquired the North American right to the anti-PD-1 antibody in February 2021 through a…

May 6, 2022

Takeda opens Ireland’s first stem cell facility

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Takeda has opened its $43 million facility in Grange Castle, Ireland, which will help supply cell therapy treatment options to the EU, Canada, and the US. Takeda Ireland, a subsidiary of Takeda Pharmaceutical Company, announced a €36 million ($43 million) investment February 2021 to build Ireland’s first commercial-scale cell therapy production facility. At the time of the announcement, Takeda declined to disclose what cell therapies it planned to manufacture at the site located 10km west of Dublin. However, the firm…

May 6, 2022