Catalent has announced an investment of $200 million in its biologics business to expand drug-substance manufacturing capacity and drug-product fill/finish capacity. The investments, phased over a three-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.

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

Additionally, fill/finish capacity at the Bloomington site will be expanded by 79,000 square feet 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.

Opened in April 2013 and recently expanded with the addition of a 2 x 2,000-liter single-use bioreactor suite and new laboratories, Catalent Biologics’ Madison facility specializes in the development, manufacturing and analytical services for new biological entities and biosimilars. It is the home of the company’s proprietary GPEx cell-line development technology. The Madison facility was designed for cGMP production from the 10-liter to 4,000-liter scale.

Catalent’s 875,000-square-foot biologics development and manufacturing facility in Bloomington has 900 employees, with expertise in sterile formulation and biomanufacturing and drug-product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges.

Source: Catalent