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Will address biologics drug substance and drug product manufacturing services
Catalent, a contract development and manufacturing organization (CDMO), is making a multi-year, $350 million investment at its facility in Bloomington, IN, to grow its biologics drug substance and drug product manufacturing capabilities. The project will assist the industry’s biologics pipeline across various modalities with new bioreactors, syringe filling lines, and additional lyophilization capacity, supported by quality control laboratories and complex automated packaging.
Specifically, the expansion includes the installation of new 2,000-liter single-use bioreactors and expanded downstream processing capabilities for drug substance, along with the capability to fill batches of up to 4,000-liters using single-use technology, or 5,000-liters using existing stainless-steel bioreactors.
The site will also be adding to the CDMO's drug product fill-finish capacity, with new syringe filling lines under barrier isolator technology and additional lyophilized vial capacity. When completed in 2024, the site’s broad range of fill-finish offerings is expected to provide flexibility in dose form presentations and batch sizes to serve customers with everything from early- and late-stage development programs, to high-volume commercial supply across various modalities.
“We continue to see strong growth in demand for biologics development and manufacturing with a deep pipeline across multiple indications,” says Mike Riley, president of biotherapeutics at Catalent. “… 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.”