Catalent Pharma Solutions, a global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products, and Valerius Biopharma AG, a Swiss biopharmaceutical company providing interchangeable treatment options for high-priced orphan and non-orphan biologics, plan 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 biologics manufacturing facility in Madison, WI.
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, more than 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 7 g/L. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, to commercial scale production, according to Catalent.
Valerius Biopharma AG was 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 experience in the development of biopharmaceutical and biosimilar compounds. 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.
(Source: Catalent Pharma Solutions)