Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it is investing $130 million to add five additional Phase 3 through commercial-scale manufacturing suites to its gene therapy campus in Harmans, Maryland to support a growing customer pipeline and market demand.
The Catalent Gene Therapy campus in Harmans, near the Baltimore Washington International (BWI) airport, comprises two state-of-the-art facilities that, when completed, will house a total of 15 gene therapy suites each designed to accommodate multiple bioreactors for commercial supply. The first Harmans/BWI facility on the campus was recently approved by the FDA for commercial manufacturing and is expected to have all 10 cGMP suites qualified and operational by the first quarter of 2021. The five new cGMP suites will be located in an adjacent building on the Harmans campus and are anticipated to be operational in the first half of 2022. The second Harmans building will also offer cold storage warehousing and additional office space.
"It is critical that we stay connected to the needs of our customers as they progress through the clinical pipeline. By increasing our late-stage manufacturing capacity at the Harmans campus, we will be able to meet demand through the medium term and take advantage of our shared resources, including the technical and manufacturing expertise that helped us reach the milestone of becoming an FDA-approved commercial partner," commented Manja Boerman, Ph.D., President, Cell & Gene Therapy at Catalent. "Catalent is committed to this journey with our customers as they bring life-changing therapies to their patients."
Catalent's state-of-the-art Harmans/BWI commercial manufacturing campus is equipped with single-use manufacturing technology, and currently includes over 200,000 square feet (18,600 square meters) of late-stage clinical and commercial-stage gene therapy production. Upon outfitting of the second building, the large-scale Harmans/BWI production campus will encompass a total footprint of approximately 350,000 square feet. The campus is one of Catalent's five gene therapy locations in Maryland and houses multiple cGMP manufacturing suites with pre-seed, bioreactor, and downstream rooms, together with fill/finish, testing, warehousing, supply chain, and central services capabilities.
About Catalent Cell & Gene Therapy
With deep experience in viral vector scale-up and production, Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) and lentiviral vectors, and CAR-T immunotherapies. When it acquired MaSTherCell, Catalent added expertise in autologous and allogeneic cell therapy development and manufacturing to position it as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global cell and gene therapy network of dedicated, large-scale clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. An experienced partner, Catalent Cell & Gene Therapy has worked with industry leaders across 70+ clinical and commercial programs.
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 over 13,900 people, including approximately 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, New Jersey. For more information, visit www.catalent.com