US-based Catalent is investing $200 million in its biologics business to expand drug substance manufacturing capacity and fill/finish capabilities at its sites in Madison, Wisconsin and Bloomington, Indiana.

The investments will be phased over a three-year program and are designed to meet projected growth among both its existing and future customers.

Catalent will build two new suites at Madison, each with a 2 x 2,000-liter single-use bioreactor system, which will expand mammalian cell culture capacity and provide additional clinical and commercial production at both the 2,000- or 4,000-liter batch scale. The company anticipates that the project, which more than doubles its commercial biomanufacturing capacity, will be complete by 2021.

At the Bloomington plant, Catalent will expand fill/finish capacity and offer both GMP and non-GMP capabilities. The company will install a high-speed flexible vial line, using both ready-to-use components and bulk filling, along with a high-speed flexible syringe/cartridge line and a fully automated vial inspection machine.

Barry Littlejohns, president of Catalent Biologics and Specialty Drug Delivery, said the expansions will support its customers’ development programs and commercial launches, bringing treatments to market faster.

The Madison facility specializes in development, manufacturing and analytical services for new biological entities and biosimilars. The Bloomington plant offers expertise in sterile formulation along with extensive biomanufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes and cartridges.

Early last month, Catalent Pharma Solutions announced it was spending nearly $14 million to expand biologics packaging capabilities and capacity at Bloomington. It will build a new facility to include five packaging suites and a quality control laboratory to be completed in February 2019.