Catalent to Invest $350 Million in Integrated Biologics Drug Substance & Drug Product Manufacturing 

Catalent recently announced a multi-year $350-million investment at its facility in Bloomington, IN, to expand biologics drug substance and drug product manufacturing capabilities. The project will serve the industry’s robust biologics pipeline across various modalities with new bioreactors, syringe filling lines, and additional lyophilization capacity, supported by quality control laboratories and complex automated packaging.

The expansion includes the installation of new 2,000-liter single-use bioreactors and expanded downstream processing capabilities for drug substance, with the versatility to meet customers’ needs with batches of up to 4,000-liters using single-use technology, or 5,000-liters using existing stainless-steel bioreactors. Also included are new quality control laboratories and complex packaging space with additional high-speed, automated cartoning and auto-injector device assembly capabilities. It is envisioned that these new capabilities will be fully operational later this calendar year.

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. When completed 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. Altogether, these expansions are expected to add over 1,000 new 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 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.

Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 30 years of proven expertise, Catalent Biologics has worked with more than 600 mAbs and more than 80 proteins, produced 16 biopharmaceutical drugs using GPEx cell line development technology, and manufactured more than 45 commercially approved products. For more information, visit biologics.catalent.com

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of nearly 7,000 products annually. Catalent’s expert workforce exceeds 19,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, NJ, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit www.catalent.com.