Catalent has commenced a $200 million capital investment in its biologics business to expand drug substance manufacturing capacity and drug product fill/finish capacity owing to projected growth among existing and future customers
The investments, phased during a 3-year programme, 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 2000 L single-use bioreactor system, providing additional clinical and commercial production capacity at the 2000 or 4000 L 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 sq. ft, with both GMP and non-GMP capabilities.
A high-speed flexible vial line, utilising 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 more than 300 units per minute, and a fully automated vial inspection machine.
“The expansions at both sites will support our customers’ development programmes and commercial launches,” commented Barry Littlejohns, President, Catalent Biologics and Specialty Drug Delivery.
He added: “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.”
Opened in April 2013 and recently expanded with the addition of a 2 x 2 000 L single-use bioreactor suite and new laboratories, Catalent Biologics’ Madison facility specialises in 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, used to create high-yielding mammalian cell lines.
This year, Catalent celebrated a significant milestone when the tenth biologic therapy utilising GPEx technology was approved for commercial use. The Madison facility was designed for cGMP production from 10 to 4000 L scale, providing flexibility in batch size to meet client needs.
Catalent’s 875,000 square-foot biologics development and manufacturing facility in Bloomington employs a growing staff of 900 employees, with deep expertise in sterile formulation and extensive biomanufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes and cartridges. The site also recently achieved regulatory approval for a twentieth commercial product.