Catalent, a provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has started a $200m capital investment to expand biologics capacity and capabilities.
Catalent will use the investment to enhance drug substance manufacturing capacity and drug product fill/finish capacity at its biologics manufacturing sites in Madison of Wisconsin and Bloomington of Indiana.
The latest investment, which has been planned over a three-year program, follows a recent announcement to invest $14m in packaging capabilities at the Bloomington site.
The investment will help the company to increase mammalian cell culture capacity at Madison site.
Catalent will construct two new suites, each with a 2 x 2,000 liter single-use bioreactor system, at Madison site to provide additional clinical and commercial production capacity at the 2,000 or 4,000-liter batch scale.
The firm intends to complete the work by mid-2021, enabling to double Catalent’s commercial biomanufacturing capacity.
Catalent will expand fill/finish capacity at the Bloomington site through building additional 79,000ft² of space with both GMP and non-GMP capabilities.
Featuring ready-to-use (RTU) components and bulk filling, a high-speed flexible vial line with filling speed of 300 units per minute will be installed at the facility.
The facility will also feature high-speed flexible syringe/cartridge line with a filling speed of over 300 units per minute and fully automated vial inspection machine.
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.”
Catalent had opened Madison facility in 2013, and recently expanded the facility through adding 2 x 2,000-liter single-use bioreactor suite and new laboratories.
Madison facility is specialized in the development, manufacturing and analytical services for new biological entities and biosimilars. The facility has GPEx cell line development technology, which is used to produce high-yielding mammalian cell lines.
The firm’s 875,000ft² biologics development and manufacturing facility in Bloomington is specialized in sterile formulation and biomanufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges.