Catalent’s sweeping workforce reductions within its Maryland gene therapy manufacturing operations were preceded by two FDA inspections in April that resulted in red flags from the agency, FDA filings reveal.
On April 1, the FDA took a visit to the CDMO’s Baltimore manufacturing site, which makes gene therapies including Sarepta Therapeutics’ Duchenne muscular dystrophy therapy Elevidys. While there, inspectors watched as a filling operator working on Elevidys manufacturing didn’t sanitize their gloves frequently enough and repeatedly performed “rapid movements” as opposed to moving “slowly and deliberately,” the Form 483 notes.
The agency also pointed to deficiencies with the building itself, finding aspects of the plant are “not maintained in a good state of repair.”
Later that month, another of Catalent’s gene therapy sites, a 20-minute drive from the Baltimore spot in Harmans, Maryland, had an FDA inspection that resulted in six observations pertaining to the manufacturing of a redacted drug product. This time, the agency took issue with certain missed or deficient testing procedures and other requirements within environmental monitoring and operator training. One observation listed in the Form 483 flagged that manufacturing equipment is “not qualified for its intended use.”
"Catalent takes all observations seriously and provided a complete and thorough response to address the agency findings," a spokesperson said in an emailed statement.
The FDA notices, first reported by Endpoints on Dec. 19, add some color to Catalent’s staffing struggles in Maryland.
In August, the manufacturer cut 350 employees from its gene therapy manufacturing division due to an “unexpected shift in demand from a large customer,” a spokesperson said at the time. The “majority” of the layoffs, according to the company, were at its Harmans campus.
The layoffs came around the same time as Sarepta was navigating its own major restructuring in the face of safety uncertainty tied to Elevidys after two patient deaths. In early August, the company disclosed that it was “evaluating opportunities to enhance operational efficiency and adjust manufacturing commitments based on [the] latest demand.”
The FDA kept a close eye on Elevidys over the summer while it investigated the patient deaths. Sarepta was briefly ordered to stop all shipments of the one-time gene therapy in July before the agency changed its stance ten days later. The company had already stopped sending out the drug to the non-ambulatory patient subset in June and the FDA has since placed an official restriction on Elevidys’ label that revokes the non-ambulatory use.
Catalent is seemingly still grappling with the Elevidys fallout, adding another 77 workers to its total Maryland headcount reduction in November. Those layoffs were again attributed to the “unexpected shift in demand” from a large commercial customer and included 61 cuts at the Harmans site and 16 between its operations in Baltimore and Hanover, Maryland.
Sarepta, which has worked with Catalent for nearly a decade and designated the CDMO as its primary Elevidys commercial manufacturing partner in 2023, explained in a quarterly filing that it had entered into a "supplemental letter agreement" with Catalent in August that addresses “certain financial and operational matters" related to the Elevidys situation. As part of the agreement, the companies plan to delay the delivery of certain Elevidys batches until “2027 and beyond,” the filing noted.
Dec. 18 marked the one-year anniversary of Catalent’s $16.5 billion buyout by Novo Holdings, sparking a recent rebrand with a new headquarters in Tampa, Florida and a fresh “championing the missions that matter” tagline.