Catalent Navigates Workforce Reductions and Regulatory Hurdles Under Novo Ownership

The contract development and manufacturing organization (CDMO) Catalent, now operating under parent company Novo Holdings, is implementing significant operational changes. These include substantial workforce reductions within its gene therapy division and ongoing regulatory complications stemming from a previously owned facility.

Strategic Realignment Following Acquisition

These operational shifts occur against the backdrop of a major corporate acquisition. In December 2024, Danish investor Novo Holdings finalized the acquisition of Catalent in an all-cash transaction valued at approximately $16.5 billion. As a key component of this arrangement, Novo Nordisk separately acquired three specific Catalent manufacturing sites for $11 billion. This landmark deal has fundamentally reshaped Catalent’s corporate structure and strategic priorities.

Gene Therapy Division Announces Major Staff Cuts

Catalent is eliminating 350 positions within its gene therapy production operations located in Baltimore, Maryland. This decision is attributed to an unexpected shift in demand from a major client, widely believed to be Sarepta Therapeutics. The majority of these job cuts will affect the company’s production campus in Harmans, Maryland.

Despite this significant reduction, company leadership maintains a positive outlook on the gene therapy sector’s long-term growth trajectory. A corporate spokesperson emphasized that remaining teams will concentrate their efforts on delivering novel treatments for patients with genetic disorders. This development highlights the inherent volatility associated with major client contracts in the specialized biopharma manufacturing industry.

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Regulatory Setbacks Impact Drug Approvals

Concurrently, regulatory issues at a former Catalent facility are creating downstream delays. The U.S. Food and Drug Administration (FDA) has extended its review timeline for two regulatory submissions concerning Regeneron’s EYLEA HD.

This delay follows observations made during an FDA inspection at a former Catalent site in Indiana, which was acquired by Novo Nordisk in December 2024. Novo Nordisk submitted a comprehensive response addressing these regulatory concerns in early August 2025. This situation underscores the persistent challenges surrounding manufacturing compliance and quality control within pharmaceutical supply chains, particularly during ownership transitions.

The recent developments at Catalent illustrate the complex landscape facing CDMOs, which must balance fluctuating client demand, stringent regulatory oversight, and operational integration following ownership changes. While scaling back its gene therapy workforce, the company continues to view this business segment as strategically vital. Meanwhile, the regulatory challenges in Indiana serve as a stark reminder of the critical importance of compliance and quality assurance protocols in pharmaceutical manufacturing.