Catalent Biologics, Valerius Biopharma To Manufacture Specialty Biosimilars
Catalent Pharma Solutions has agreed to collaborate with Valerius Biopharma AG, a Basel Switzerland-headquartered biopharmaceutical company focused on biosimilars, to develop and manufacture 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, Wisconsin. Catalent Biologics’ Madison site was opened in April 2013 and recently expanded and provides development, manufacturing, and analytical services for new biological entities and biosimilars. The facility was designed for cGMP production from 10 liters up to 4,000-liters and non-GMP production up to 250 liters.
The project will use Catalent’s proprietary GPEx technology, which creates production cell lines in a wide variety of mammalian host cells.
Valerius’ current product pipeline comprises four biosimilar products in different development stages.