Catalent investing $130m to up US gene therapy capacity

Catalent will add five additional Phase III through to commercial-scale manufacturing suites to its gene therapy campus in Harmans, Maryland.

The US contract development and manufacturing organization (CDMO) cited growing customer pipelines and an increase in demand as the driver for the investment.

Randy Hendrickson, VP Commercial Operations, Catalent Cell & Gene Therapy told us: “Upon completion in the first half of 2022, the facility will house multiple cGMP manufacturing suites with pre-seed, bioreactor, and downstream rooms alongside fill/finish, testing, warehousing, supply chain, and central services capabilities.

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“The $130 million investment will add five manufacturing suites to respond to demand for adeno-associated virus and lentiviral vectors, and CAR-T immunotherapies.”

Hendrickson added, “The investment will add five additional Phase III through commercial-scale manufacturing suites, bringing the total number to 15 suites upon completion, each designed to accommodate multiple bioreactors for commercial supply.”

Hendrickson declined to talk about capacity, explaining that “because programs are linked to our partners’ treatments, it is not possible to say how many doses will be produced.”

The first Harmans facility was recently approved by the US FDA for commercial manufacturing and is expected to have all 10 cGMP suites qualified and operational by the first quarter of 2021.

According to the firm, the five new cGMP suites will be located in an adjacent building on the Harmans campus. The second Harmans building will also offer cold storage warehousing and additional office space.

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.

Catalent cited recent purchases in the cell and gene therapy – specifically the February acquisition of Masthercell and 2019 takeover of Paragon Bioservices – as major growth drivers during its Q4 earning call earlier this month.