Catalent has started $200m capital investment to expand drug substance manufacturing and drug product fill/finish capabilities at US sites.
As part of a three-year program, Catalent will use the investment to enhance capabilities at its manufacturing sites in Madison of Wisconsin and Bloomington of Indiana.
The current investment is following a recent announcement to invest $14m in packaging capabilities at the Bloomington site.
Catalent has announced plans to expand fill/finish capacity at the Bloomington site through the development of 79,000ft² of space with both GMP and non-GMP capabilities.
Featuring both ready-to-use (RTU) components and bulk filling options, a high-speed flexible vial line with filling speed of 300 units per minute will be installed at the facility.
The company will also install high-speed flexible syringe/cartridge line with a filling speed of over 300 units per minute and fully automated vial inspection machine at the facility.
Catalent will also use the investment to increase mammalian cell culture capacity at Madison site. It will build two new suites, each with a 2 x 2,000 liter single-use bioreactor system, at the site to provide additional clinical and commercial production capacity at the 2,000 or 4,000-liter batch scale.
Expected to be completed by mid-2021, the expansion will enable Catalent to double its bio-manufacturing capacity.
Catalent biologics and specialty drug delivery president Barry Littlejohns said: “The expansions at both sites will support our customers’ development programs and commercial launches.
“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.”
The company had opened Madison facility in April 2013, and recently expanded the facility through building 2 x 2,000-liter single-use bioreactor suite and new laboratories.
The Madison facility provides development, manufacturing and analytical services for new biological entities and biosimilars. It features GPEx cell line development technology, which is used to create high-yielding mammalian cell lines.
The 875,000ft² biologics development and manufacturing facility in Bloomington offers sterile formulation and extensive bio-manufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges.