US-based Catalent and Swiss company Valerius Biopharma have said they will collaborate on the development and manufacture of Valerius’ biosimilar products.
Catalent Pharma Solutions is a specialist provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. Valerius Biopharma, is a biopharmaceutical company dedicated to providing interchangeable treatment options for high-priced orphan and non-orphan biologics.
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 utilise 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 more than 50 different recombinant proteins have been produced using the GPEx system, achieving large scale fed-batch production titers of more than 7 g/l.
The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, to commercial scale production.
Valerius Biopharma 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.
“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.”
Opened in April 2013 and recently expanded, Catalent Biologics’ Madison site provides development, manufacturing and analytical services for new biological entities and biosimilars.
