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The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.
Catalent announced on Jan. 7, 2019 a $200-million investment 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 carried out at the company’s biologics manufacturing sites in Madison, WI, and Bloomington, IN. This follows a December 2018 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 2000-liter single-use bioreactor system, providing additional clinical and commercial production capacity at the 2000- or 4000-liter batch scale as well new laboratories. Work is expected to be completed by mid-2021 and will more than double Catalent’s commercial biomanufacturing capacity, the company reports.
Additionally, fill/finish capacity at the Bloomington site will be expanded by 79,000 ft2, with both GMP and non-GMP capabilities. A high-speed flexible vial line, using both ready-to-use 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, Catalent Biologics’ Madison facility specializes in development, manufacturing, and analytical services for new biological entities and biosimilars. The facility houses the company’s proprietary GPEx cell-line development technology, used to create high-yielding mammalian cell lines. The Madison facility was designed for cGMP production from 10- to 4000-liter scale.
The company’s 875,000- ft2 biologics development and manufacturing facility in Bloomington has 900 employees with expertise in sterile formulation and extensive biomanufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges.