The 23,000-square-foot facility, purchased from AB BioTechnologies, Inc. and its affiliate, includes a new Vanrx SA25 aseptic flexible filling line capable of filling liquid and lyophilized vials, syringes, or cartridges under barrier isolator technology, while also providing rapid changeover for faster manufacture of clinical batches. The facility also has formulation development capabilities, quality control laboratories, and controlled temperature storage for biologic and sterile products. The site will be fully integrated with Catalent Biologics’ main Bloomington facility located nearby, where the company recently announced a $50 million investment to install an additional high-speed vial filling line.
“The addition of this new small-scale filling capability underlines Catalent’s commitment to our customers with early stage programs looking to accelerate molecules into the clinic,” said Mike Riley, Catalent’s Region President, Biologics, North America. “The filling line will also be fully leveraged as part of our OneBio offering, an integrated solution for drug substance and drug product development, manufacturing and clinical supply, enabling faster development timelines to Phase 1 clinical trials and beyond.”
This new line brings the drug product fill/finish manufacturing capacity across both Bloomington facilities to three high-speed vial lines, two high-speed syringe lines, one high-speed flexible filling line, and one small-scale flexible filling line, all of which is expected to be available by the end of 2021.
Catalent Biologics will now offer its customers a center of excellence for clinical biologics formulation development and drug product fill/finish services in both North America and Europe following the recent announcement of a $30 million investment at its Limoges, France site.