Catalent Biologics and Valerius Biopharma to Collaborate on Manufacture of Specialty Biosimilars
Catalent Pharma Solutions and Valerius Biopharma AG, a Swiss biopharmaceutical company dedicated to providing interchangeable treatment options for high-priced orphan and non-orphan biologics, announced that they are to collaborate on the development and manufacture of Valerius’ biosimilar products.
Under the agreement, Catalent Biologics will provide cell line development and support cGMP manufacturing activities from Phase I through to commercial stages at its state-of-the-art biologics manufacturing facility in Madison, Wisconsin.
The project will utilize Catalent’s proprietary GPEx® technology, which creates high-performance, highly stable production cell lines in a wide variety of mammalian host cells. To date, over 460 different mAb and mAb fusions, and over 50 different recombinant proteins have been produced using the GPEx system achieving large scale fed-batch production titers of over 7 g/L. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, to commercial scale production.
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