Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, 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 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.
Valerius Biopharma AG is a biopharmaceutical company founded to develop biosimilar products as alternatives to high-priced biologics, for indications where there is a substantial medical need. The company has built a research and development hub of scientists and experts with decades of experience in the development of biopharmaceutical and biosimilar compounds, as well as profound clinical and regulatory expertise. The company’s current product pipeline comprises four biosimilar products in different development stages.
Opened in April 2013 and recently expanded, Catalent Biologics’ Madison site provides development, manufacturing and analytical services for new biological entities and biosimilars. The facility was designed for flexible cGMP production from 10 liters up to 4,000-liter scale, and non-GMP production up to 250-liter scale and makes extensive use of single-use technologies and unidirectional flow to maximize safety and efficiency. Manufacturing is supported by integrated analytical, process and formulation development capabilities and separate microbiology and quality control functions.