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, are collaborating on the development and manufacture of speciality biosimilars.
Structured collaboration
Under the terms of the agreement, Catalent Biologics will provide cell line development and support current good manufacturing practice (cGMP) activities from Phase I through to commercial stages at its facility in Madison, Wisconsin.
Additionally, this collaboration will see the companies use Catalent’s GPEx technology for the creation of high-perfomance, highly stable production cell lines in a wide variety of mammalian host cells.
“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. “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.”