Catalent to double its commercial biomanufacturing capacity

7 Jan 2019

The $200-million expansion will support customers’ development programs and commercial launches.

Catalen has commenced a $200-million capital investment in its biologics business to expand drug substance manufacturing capacity and drug product fill/finish capacity due to projected growth among existing and future customers. The investments, phased over a 3-year program, will be undertaken at the company’s biologics manufacturing sites in Madison, Wisconsin and Bloomington, Indiana. This follows a recent announcement to invest $14 million in packaging capabilities at the Bloomington site.

Catalent to double its commercial biomanufacturing capacity

Mammalian cell culture capacity will be increased at Madison with the build out of two new suites, each with a 2 x 2,000-L single-use bioreactor system, providing additional clinical and commercial production capacity at the 2,000 or 4,000-L batch scale. Work is expected to be completed by mid-2021 and will more than double Catalent’s commercial biomanufacturing capacity.

In addition, fill/finish capacity at the Bloomington site will be expanded by 79,000 sq ft, with both GMP and non-GMP capabilities. A high-speed flexible vial line, utilizing both ready-to-use (RTU) components and bulk filling, at a filling speed of 300 units per minute, will be installed along with a high-speed flexible syringe/cartridge line with a filling speed of over 300 units per minute, and a fully automated vial inspection machine.

“The expansions at both sites will support our customers’ development programs and commercial launches,” commented Barry Littlejohns, President, Catalent Biologics and Specialty Drug Delivery. He added: “Catalent’s continued investments in innovative technologies and flexible capacity allow us to offer the most comprehensive solutions to bring important and innovative treatments to market faster.”

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