Catalent, a CDMO for the biopharma industry, has announced a multi-year $350m investment at its facility in Bloomington, Indiana, to expand biologics drug substance and drug product manufacturing capabilities. The project is aimed to improve the industry’s biologics pipeline across various modalities with bioreactors, syringe filling lines, and additional lyophilisation capacity, supported by quality control laboratories and complex automated packaging.
The expansion includes the installation of 2000 L single-use bioreactors and expanded downstream processing capabilities for drug substance, with the versatility to handle batches of up to 4000 L using single-use technology, or 5000 L using existing stainless-steel bioreactors. Also included are quality control laboratories and complex packaging space with additional high-speed, automated cartoning and auto-injector device assembly capabilities. These capabilities are planned to be fully operational by the end of 2022.
The site will also be adding to its drug product fill/finish capacity, with additional syringe filling lines under barrier isolator technology and additional lyophilised vial capacity. When completed in 2024, the site’s fill/finish offerings will provide greater flexibility in dose form presentations and batch sizes to address the manufacturing cycle from early- and late-stage development programmes to high-volume commercial supply across various modalities.
Altogether, these expansions are expected to add more than 1,000 jobs to Catalent’s Bloomington workforce in the coming years.
“We continue to see strong growth in demand for biologics development and manufacturing with a deep pipeline across multiple indications,” commented Mike Riley, President of Biotherapeutics at Catalent. “These investments will enable us to expand our flagship Bloomington facility and extend our leadership as one of the largest and most comprehensive global centres for integrated manufacturing capabilities. The site offers highly flexible and scalable solutions to companies developing new biological drugs, vaccines, RNA therapies, and other innovative treatments for patients around the world.”
This expansion follows a series of recent investments in the company’s global network, including the modernisation of its fill/finish and packaging facility in Limoges, France, and the acquisition of a new biologics development and manufacturing facility near Oxford, UK.
