At Harmans, the CDMO with headquarters at Someret, New Jersey, is in the process of installing two state-of-the-art facilities that when completed will house altogether 15 gene therapy suites, each designed to accommodate multiple bioreactors for commercial supply.

With the first facility recently approved by the US Food and Drug Administration (FDA), the plan is to have all of the site’s10 cGMP suites operating and qualified for commercial manufacturing by Q1 2021.  The five new cGMP suites, to be housed in an adjacent building, are expected to be operational in H1 2022. A second building will also offer cold storage warehousing and additional office space.

The Maryland campus is one of five gene therapy locations Catalent operates in the US state and is home to multiple cGMP manufacturing suites with pre-seed, bioreactor and downstream rooms, together with fill/finish, testing, warehousing, supply chain, and central services capabilities.

“By increasing our late-stage manufacturing capacity at the 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, Catalent’s president, Cell & Gene Therapy.

The company unit operates a global cell and gene therapy network of dedicated, large-scale clinical and commercial manufacturing facilities and fill-finish and packaging capabilities in both the US and Europe.

From the Harmans campus, Catalent Cell & Gene Therapy is providing drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine candidate. The CDMO also has contracts with other potential Covid-19 vaccine makers that have candidates in clinical trials.

Author: Dede Williams, Freelance Journalist