Ferring Expands Adstiladrin Production Capacity with New Facility in Finland
核心洞察
Ferring is expanding its manufacturing capabilities with a new 25,000 square meter facility in Finland to produce the drug substance for Adstiladrin.
The expansion follows FDA approval of Ferring's scale-up process in June 2023 and a partnership with SK pharmteco (搜索) to further increase manufacturing capacity.
Adstiladrin, an adenovirus vector-based gene therapy, received FDA approval in 2022 as the first gene therapy for bladder cancer (搜索), administered via catheter directly into the bladder.
Ferring Pharmaceuticals is significantly increasing its production capacity for Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy for bladder cancer (搜索), with a new manufacturing facility in Finland. The 25,000 square meter facility will focus on producing the drug substance (DS) for the adenovirus vector-based gene therapy. This expansion follows FDA approval of Ferring's scale-up process in June 2023.
Manufacturing Expansion Details
In addition to the Finland facility, Ferring is nearing completion of a drug product (DP) manufacturing facility at its Parsippany, New Jersey campus. This fill/finish plant will concentrate on final drug product manufacturing. According to a Ferring spokesperson, larger-scale production at the New Jersey site is anticipated to commence within the coming years, pending FDA and other necessary approvals. The new unit will incorporate sustainable energy solutions, including solar energy utilization and waste heat recovery, and the company is applying for LEED environmental certification for its sustainable development.
Adstiladrin's Role in Bladder Cancer Treatment
Adstiladrin, approved by the FDA in 2022, represents a significant advancement as the first gene therapy for bladder cancer (搜索). The intravesical, non-replicating gene therapy is administered locally via catheter directly into the bladder every three months. It works by targeting the patient’s own bladder wall cells to enhance the body’s natural defenses against the cancer. Ferring announced full commercial availability of Adstiladrin in the US in January 2024.
Strategic Partnerships and Commitment
Ferring has also partnered with contract development and manufacturing organization (CDMO) SK pharmteco (搜索) to scale up commercial manufacturing capacity for the DS used in Adstiladrin. This agreement, established in April 2024, includes a technology transfer of the adenoviral vector-based gene therapy DS for the manufacturing process, as well as analytical test methods for release and stability testing.
"The continued investment and expansion of our gene-therapy manufacturing infrastructure reflects Ferring’s strong commitment to deliver end-to-end solutions for even the most highly complex manufacturing challenges as part of our mission to fulfill the unmet clinical needs for people with bladder cancer (搜索)," said Armin Metzger, chief technical operations officer, Ferring Pharmaceuticals.