Catalent Acquires New Biologics Facility to Create North American Clinical Manufacturing Center of Excellence

Catalent recently announced it has acquired a new manufacturing facility in Bloomington, IN, to create a North American center of excellence for early phase clinical biologics formulation development and drug product fill/finish services. The $14-million investment includes the acquisition, build-out, and qualification of the facility to begin supporting customer programs starting January 2021.

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.

Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx cell line development technology, and manufactured 35+ commercially approved products. Catalent Cell & Gene Therapy, a unit of Catalent Biologics, is a full-service partner for adeno-associated virus (AAV) vectors, lentiviral vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. When Catalent acquired MaSTherCell, it added expertise in autologous and allogeneic cell therapy development and manufacturing. Catalent Cell & Gene Therapy has worked with worked with industry-leading partners across 70+ clinical and commercial programs. For more information, visit biologics.catalent.com

 Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 14,000 people including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, NJ. For more information, visit www.catalent.com.

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