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The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.
On Sept. 9, 2020, Catalent announced that it is investing $130 million to expand manufacturing capacity at its gene therapy campus in Harmans, MD. The expansion, intended to support the gene therapy product pipeline and growing market demand, will include the addition of five Phase III through commercial-scale manufacturing suites.
The gene therapy campus has two facilities, and when expansion is completed, the campus will house a total of 15 gene therapy suites, each of which will be able to accommodate multiple bioreactors for commercial supply. FDA recently approved the first facility on the campus for commercial manufacturing, and the first facility is expected to have 10 current good manufacturing practices (cGMP) suites qualified and operational by the first quarter of 2021. The five new cGMP suites will be located in an adjacent building and are expected to come online in the first half of 2022. A second facility will offer cold storage warehousing and additional office space.
The campus is equipped with single-use manufacturing technology, including more than 200,000 ft2 (18,600 m2) of late-stage clinical and commercial-stage gene therapy production. When the second building is outfitted, the campus will encompass a total footprint of approximately 350,000 ft2.
“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,” said Manja Boerman, PhD, president, Cell & Gene Therapy, Catalent, in a company press release.