Friday, October 5, 2018 Daily Archives

Dynamic Dialysis: A Novel Process-Scale Membrane Separation for GMP Manufacturing

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This webcast features: Daniel (Danny) Spurgin, Product Manager, and Cassidy Markee, Bioprocess Sales Specialist, Repligen While static dialysis is used routinely in research and sample analysis, dynamic dialysis is increasingly used today for the purification of macromolecules, proteins, nanoparticles, biomolecules, polymers (polypeptides, polysacharide, oligos), virus for vaccine and delicate/shear sensitive species. It is also ideal for the purification of viscous fluids and hydrogels (hyaluronic acid – HA) that cannot be filtered. Where traditional filtration methods may fail, dynamic dialysis uses…

October 5, 2018

Yescarta: Gilead boasts 60 CAR-T clinics and counting

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There are now 60 different centers certified to administer CAR-T therapy Yescarta says Gilead Sciences says, which plans to add more as further indications are approved. In October 2017, the US Food and Drug Administration (FDA) approved the second chimeric antigen receptor T-cell therapy in the form of Yescarta (axicabtagene ciloleucel), developed by Kite which had recently been acquire by Gilead Sciences for $11.9 billion (€10.2 billion). Yescarta is made by isolating peripheral blood mononuclear cells – including T-cells –…

October 5, 2018

Bayer restructures factor VIII manufacturing, cuts 17% of jobs at Cali site

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Bayer will axe 227 jobs at its Berkeley, California site as it looks to restructure its recombinant factor VIII manufacturing network. The news comes weeks after its hemophilia treatment Jivi received US approval. Recombinant factor VIII protein (rFVIII) is used for the treatment of hemophilia A and employs genetically modified cells in its production. Bayer’s plant in Berkeley, California, is responsible for producing all three of its rFVIII therapies, including Jivi, a pegylated, longâ€acting plasma/albumin free, fullâ€length rFVIII. The product…

October 5, 2018

Sanofi and Regeneron gain approval for skin cancer MAb

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The US FDA has approved skin cancer drug Libtayo, a programmed cell death protein-1 (PD-1) inhibitor developed through a Sanofi and Regeneron collaboration. In 2007, Sanofi teamed up with Regeneron Pharmaceuticals to discover, develop, and commercialize fully-human therapeutic antibodies. While the discovery collaboration ended last year, Sanofi still owns a 22% stake in Regeneron. The the firms also continue to develop and commercialize a number of monoclonal antibodies, including its metastatic cutaneous squamous cell carcinoma (CSCC) product cemiplimab which the two…

October 5, 2018