Catalent breaks ground on WI expansion to support commercial biomanufacturing
In August, Catalent announced it was planning to invest $34m (€31m) into its single-use biologics production site in Madison to add two 2,000L single-use bioreactor systems.
And last month the contract development and manufacturing organisation (CDMO) broke ground on the extension which, according to Mike Riley - VP and general manager of Catalent Biologics – will allow the firm to expand its offering to include commercial scale biologics.
“Upon completion of our expansion, we will be able to offer single use cGMP manufacturing batch sizes of 250 L, 500 L, 1,000 L, 2,000 L and 4,000 L,” he told Biopharma-Reporter.com. “This will provide a range of manufacturing options to our customers from early phase clinical to Phase III and commercial production.”
There has been continued investment at the former-GE Healthcare site ever since it began operations for Catalent in 2013, adding a 1,000L bioreactor in 2015 for example.
Riley said the firm has been responding to customers requiring small to medium scale capacity, but the latest expansion will “support the next phase of the site's growth into Phase III and commercial production.”
Consolidated Bio-CMO space
But according to PharmSource’s Jim Miller at a recent industry event, over half of all commercial biologics being made by third-parties are currently contracted to Lonza and Boehringer-Ingelheim, and the rest of the bio-CMO space is “extremely consolidated.”
Therefore we asked Riley how Catalent intended to compete.
“We offer customers a compelling value proposition based on our proprietary technology platforms, flexible development and manufacturing solutions, and specialised capabilities in areas like protein characterization and bioassay services,” he said.
“This allows us to provide a high value-add, flexible solution to customers advancing biologic molecules through the clinic and to the market.”
He added the firm has attracted “some of the most innovative biotech companies in the world” and “this capacity expansion, along with continued advancement and deals around our proprietary technology platforms, will further strengthen our offering.”
Last month, the firm was contracted by Samsung Bioepis to provide fill/finish services for its Enbrel biosimilar, recently approved in the EU and Canada.