Catalent Pharma Solutions, a global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, and Valerius Biopharma, a Swiss biopharmaceutical company dedicated to providing interchangeable treatment options for high-priced orphan and non-orphan biologics, have announced that they are to collaborate on the development and manufacture of Valerius’ biosimilar products.

Valerius Biopharma’s current product pipeline comprises four biosimilar products in different development stages. Under the agreement, Catalent Biologics will provide cell line development and support cGMP manufacturing activities from Phase 1 through to commercial stages at its state-of-the-art biologics manufacturing facility in Madison, Wisconsin, USA.

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 monoclonal antibodies and monoclonal antibody fusions, and over 50 different recombinant proteins have been produced using the GPEx system, achieving large scale fed-batch production titers of over 7g/L. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, to commercial scale production.

“Our business mission is to make the treatment of severe, life-threatening and rare diseases more affordable for patients worldwide by developing biosimilars that meet the highest regulatory standards,” commented Andreas Herrmann, CEO of Valerius. He added, “We selected Catalent as our development and manufacturing partner because of their technical knowledge and expertise in the cGMP manufacture of biosimilars, and proven track record in bringing innovative treatments to market.”

Mike Riley, Vice President and General Manager of Drug Substance and Bioanalytical Services, Catalent Biologics, added, “We are pleased to partner with Valerius on their biologic-based therapeutics for many important indications. We look forward to supporting them in their goal of producing affordable biosimilars that will provide more equal access to medicinal products.”