Thursday, August 16, 2018 Daily Archives

Ex-Shire director to aid Catalent’s shift to commercial manufacturing

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The new general manager at Catalent’s facility in Wisconsin says his experience at Baxter and Shire will help the plant transition towards commercial manufacturing. Contract development and manufacturing organization (CDMO) Catalent has appointed Graham Brearley as general manager of its Madison, Wisconsin facility. With over 25 years’ of technical, operations and business experience in the biopharmaceutical industry, BioProcess Insider spoke to him about his move to a third-party services firm and his vision for Madison – and Catalent – going…

August 16, 2018

Jazz scales back Erwinaze push due to manufacturing disruptions

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To minimize impact on patients, Jazz Pharmaceuticals has reduced promotion of its cancer drug due to continued manufacturing issues at its CMO Porton Biopharma Limited (PBL). Erwinaze (asparaginase Erwinia chrysanthemi), an asparaginase enzyme derived from the bacteria Erwinia chrysanthemi, is used for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. The product is made for Jazz Pharmaceuticals by Wiltshire, UK-based and UK-government backed biomanufacturer PBL. However, the US Food and Drug…

August 16, 2018