Catalent to invest $350m to expand US drug substance and product manufacturing site

By Jane Byrne contact

- Last updated on GMT

© GettyImages/lisegagne
© GettyImages/lisegagne

Related tags: Catalent, Biologics, Vaccines

Catalent has announced a multi-year $350m investment at its facility in Bloomington, Indiana, to expand biologics drug substance and drug product manufacturing capabilities.

The company said the project will serve the industry’s robust biologics pipeline across various modalities.

The expansion, continued the CDMO, will see new bioreactors, syringe filling lines, and additional lyophilization capacity, supported by quality control laboratories and complex automated packaging, high-speed, automated cartoning and auto-injector device assembly capabilities.

Catalent is to install new 2,000-liter single-use bioreactors and expanded downstream processing capabilities for drug substance. The idea is to give the plant the versatility to meet customers’ needs, catering to batches of up to 4,000-liters using single-use technology, or 5,000-liters using existing stainless-steel bioreactors.

The organization said those new capabilities should be fully operational later this calendar year.

Fill/finish capacity

The site will also be adding to its drug product fill/finish capacity, with new syringe filling lines under barrier isolator technology and additional lyophilized vial capacity, like online in 2024.

“The site’s broad range of fill/finish offerings will provide great 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.”

The project, said Catalent, is set to add over 1,000 new jobs to its Bloomington workforce in the coming years.

Mike Riley, president of biotherapeutics at Catalent, said the investments would make it one of the largest and most comprehensive global centers 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 Catalent Biologics’ global network, including the modernization of its fill/finish and packaging facility in Limoges, France, and the acquisition of a new biologics development and manufacturing facility​ near Oxford, UK.

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