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Catalent and Valerius to collaborate on manufacture of specialty biosimilars

By Catalent ·

Project will use Catalent’s proprietary GPEx technology, which creates high-performance, highly stable production cell lines in a wide variety of mammalian host cells.

Catalent Pharma Solutions and Valerius Biopharma are to collaborate on the development and manufacture of Valerius’ biosimilar products.

Catalent and Valerius to collaborate on manufacture of specialty biosimilars

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 use 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.

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.”

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.”

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 L up to 4,000-L scale, and non-GMP production up to 250-L 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.

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