Additions to the plant – a 3,300 sq ft facility based in Research Triangle Park (RTP) – include a new class A manufacturing space with an aseptic vial filling line for Phase I and II clinical trial materials.
The facility already handles sterile product formulation and development, stability testing and analysis as well as process development.
Speaking to Outsourcing-Pharma.com Christine Dolan, VP and general manager of Catalent’s development and analytical solutions business, said: “This investment is an upgrade to enhance our existing expertise and offerings and to increase our capacity in response to customer feedback.
“Our RTP site has capabilities and licenses to handle a wide array of materials including proteins, peptides, controlled substances, potents and biologics. With the full service offerings, our experts can take all of these materials from formulation and development through clinical trial production.”
She added that operations were flexible and can be “tailored to suit customers’ needs.”
Tightening the focus
Dolan told us the new addition will support pipeline expansions which will ramp-up Catalent’s biologics offering.
In particular, she mentioned the constructions underway in Madison, Wisconsin , which is set to increase its GPEx cell line engineering technology and biomanufacturing.
She described the new service offering as “a natural fit with Catalent’s proprietary GPEx technology and mammalian cell line manufacturing capabilities.
“Combining our broad large molecule analytical capabilities and world leading clinical trial supply services, we can help biologic and biosimilar drug development customers to accelerate their drug from gene to market.”
Her comments echo those of VP of global marketing and strategy, Elliott Berger, who earlier this week spoke to us about the sale of the US commercial packaging operations .
He listed three key focuses for Catalent in coming months - oral dose forms, clinical supply solutions and biologics. “We see growth in the biologics development area,” he said.