Ferring Builds A Global Gene Therapy Manufacturing Network Around ADSTILADRIN

By Erin Harris, Editor-In-Chief, Cell & Gene
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As gene therapy continues to redefine what’s possible in the treatment of serious diseases, the commercial challenges that accompany this modality are becoming just as critical to address as the science itself. Ferring Pharmaceuticals, through its early investments and long-term strategy, has taken decisive steps to ensure that its flagship gene therapy, ADSTILADRIN, can scale to meet patient needs in the U.S. and globally.

Recently, the company achieved a major milestone with FDA approval of its Parsippany, NJ facility, an ADSTILADRIN-dedicated drug product manufacturing site. According to Bipin Dalmia, Global Head of the Uro-Oncology and Urology Franchise at Ferring and a board member at sister company FinVector, this expansion cements Ferring’s position as one of the few drug developers with the infrastructure and technical depth to manage the complexities of viral-based gene therapy at scale.

Building for a Supply-Unconstrained Future

Gene therapy manufacturing is notoriously complex and often has limited capacity. Rather than wait for commercial pressures to arise, Ferring began building out its internal capabilities during ADSTILADRIN’s clinical development. This foresight now enables a “supply unconstrained” strategy — one that aims to meet existing demand while preparing for future growth and expanded indications. “Our new Parsippany facility marks a major milestone in strengthening our global manufacturing network,” said Dalmia. “It complements our established sites in Kuopio, Finland, and our partnership with SK pharmteco. Together, they form a resilient, multi-site international ecosystem.”

That ecosystem is central to Ferring’s ambitions beyond bladder cancer. Dalmia emphasized that the company’s global network — along with its expertise in managing the intricacies of viral-based gene therapies — positions Ferring as an ideal collaborator for future gene therapy partnerships.

Learning from Finland, Building in the U.S.

Ferring’s Finland site laid the groundwork for its U.S. manufacturing strategy. The Kuopio facility was instrumental in enabling full availability of ADSTILADRIN in the U.S. by January 2024, and its operational success offered valuable insights into scale-up, process robustness, and long-term manufacturing stability.

These lessons shaped the design of the Parsippany facility, which features a 12,000-square-foot drug product manufacturing suite. Outfitted with cutting-edge equipment and renewable energy features, such as solar power and waste heat recovery, the site was built with both sustainability and flexibility in mind. “The close collaboration between our Finland and U.S. teams enabled us to obtain first-cycle FDA approval, which underscores the importance of tech transfer and operational continuity,” he said.

Training Urologists on a Gene Therapy

One of ADSTILADRIN’s distinctive characteristics is its mode of delivery: a non-replicating viral vector administered directly into the bladder via catheter. While the route of administration is familiar to urologists, the novelty of gene therapy calls for added support and education. Ferring’s approach includes robust onsite training through Clinical Nurse Educators (CNEs), who walk providers through the process and emphasize the product’s simplicity, as ADSTILADRIN is supplied in a ready-to-use vial and does not require reconstitution or dilution. “It’s the only intravesical therapy dosed once every three months,” Dalmia noted. “With durable complete response data extending up to five years, ADSTILADRIN offers a promising option after BCG failure.”

Ferring also provides resources through its dedicated healthcare provider website (www.ADSTILADRINHCP.com), including clinical overviews and instructional videos.

Reimbursement Built on Infrastructure and Trust

For any new therapy, especially one in a complex area such as gene therapy, reimbursement can be a major barrier. But Ferring has made substantial progress: ADSTILADRIN’s average reimbursement timeline is now just 25 days, with 99% coverage among commercially and government-insured patients.

This success is anchored by Ferring’s Access Support program, which streamlines benefits verification and prior authorizations while helping providers navigate the process confidently. Just as critical, early inclusion in National Comprehensive Cancer Network (NCCN) guidelines helped align payer policies with clinical value. “Partnerships with payers and a strong infrastructure were key to this outcome,” he said. “It reflects our commitment to reducing barriers and supporting both patients and providers.”

Expanding Gene Therapy Access in the Community

While awareness of gene therapy is growing, familiarity varies widely across practice settings. To address this, Ferring is doubling down on provider engagement, especially in community settings where resources may be more limited. “We offer personalized support to help practices integrate ADSTILADRIN, whether it’s through our website, in-person training, or our access program,” explained Dalmia. “Inclusion in NCCN and AUA/SUO guidelines also builds confidence for clinicians making treatment decisions.”

By bridging educational and operational gaps, Ferring is working to ensure that more eligible patients can access ADSTILADRIN, regardless of where they’re treated.

The Next Frontier: Real-World Insights

More than 1,500 patients have now been treated with ADSTILADRIN in real-world settings across the U.S. Ferring is leveraging this momentum to gather a deeper understanding of how the therapy performs outside of controlled trials. “We’re focused on both clinical and patient-reported outcomes,” said Dalmia. “This helps us better understand the therapy’s impact and refine our approach to personalized care.”

Ferring’s ongoing research in uro-oncology — along with internal and collaborative R&D —will continue to inform next steps for ADSTILADRIN and potentially other gene therapy candidates.

A Vision for Gene Therapy at Scale

From bench to bedside, ADSTILADRIN represents a convergence of innovation, operational readiness, and clinical commitment. As Ferring scales its impact, the company’s investments in manufacturing, education, access, and real-world evidence are redefining what it means to bring gene therapies to market sustainably. “We envision a future where gene therapy is both practical and transformative,” Dalmia concluded. “With ADSTILADRIN, we’re showing how that vision can be realized, starting with the patients who need it most.”