Catalent is investing US$350 million in Bloomington, Indiana to expand its biologics drug substance and therapeutic product manufacturing capabilities.
The project will support the industry's extensive biologics pipeline in a variety of ways.
Additionally, bioreactors, syringe filling lines, and lyophilization capacity will be added, as well as quality control laboratories with automated packaging.
In addition, the company will install additional 2,000-liter single-use bioreactors and expand its medicinal material downstream processing capabilities. The goal is to provide the company with the flexibility to satisfy clients' needs with batches as small as 4,000 litres utilizing single-use technology or as large as 5,000 litres using existing stainless-steel bioreactors.
Furthermore, quality control laboratories and complicated packaging areas with high-speed, automated cartoning and auto-injectors are also incorporated.
These additional capabilities should be fully operational later this year.
New syringe filling lines using barrier isolator technology and additional lyophilized vial capacity will be added to the site's pharma product fill/finish capabilities.
The site's broad range of fill/finish offerings will provide enhanced flexibility in dose form presentations and batch sizes when it is completed in 2024, allowing customers to serve customers with everything from early- and late-stage development programmes to high-volume commercial supply across multiple modalities.
In the next couple of years, the project expects to add over 1,000 additional jobs to its Bloomington staff.