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 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 sq. ft., 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.
“The expansions at both sites will support our customers’ development programs 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-liter single-use bioreactor suite and new laboratories, Catalent Biologics’ Madison facility specializes 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 utilizing GPEx technology was approved for commercial use. The Madison facility was designed for cGMP production from 10 to 4,000-liter 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.
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Catalent Biologics provides advanced technologies and tailored solutions for biologic and biosimilar development, from DNA to commercial supply, through our extensive Biologics network including: Madison, Wisconsin; Emeryville, California; Kansas City, Missouri; Morrisville, North Carolina, Bloomington, Indiana; and Brussels, Belgium. For more information on Catalent Biologics, visit www.catalent.com/biologics.
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal 2018 generated approximately $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.