Ferring selects SK Pharmteco to manufacture gene therapy

Contract development and manufacturing organization (CDMO) SK pharmteco will scale up commercial manufacturing capacity for the drug substance Adstiladrin (nadofaragene firadenovec).

“By partnering with SK pharmteco, Ferring Pharmaceuticals can tap into the expertise and infrastructure of a specialized manufacturing partner to scale up production of Adstiladrin to meet projected commercial growth,” a spokesperson for Ferring told BioProcess Insider.

“Ferring Pharmaceuticals is not in a manufacturing partnership with any other CDMO for Adstiladrin. The need to scale up supply of strategically for bladder cancer across geographies is demonstrated by the trend of increased disease prevalence worldwide.”

Adenovirus vector-based gene therapy Adstiladrin was approved by the US Food and Drug Administration (FDA) in 2022 as the first gene therapy for bladder cancer. Every three months, the gene therapy is administered locally as a monotherapy by catheter directly into the bladder. The intravesical non-replicating gene therapy targets the patient’s own bladder wall cells to enhance the body’s natural defenses to fight cancer.

The agreement includes a technology transfer of the adenoviral vector- based gene therapy drug substance for the manufacturing process, and analytical test methods for release and stability testing. The facility, including the equipment, needs to be ready and validated, and technical batches will be manufactured followed by process validation.

“SK pharmteco was selected based on their competencies and alignment on core values across the two companies following a thorough assessment of potential CDMOs with gene therapy development and GMP manufacturing capabilities,” the spokesperson said.

Additionally, Ferring has expanded capacity for Adstiladrin at its existing sites in Espoo, Finland and Parsippany, New Jersey.

“The expansion project in the US is a new plant, whereas the expansion project in Finland is in the existing facility in Kuopio. No further updates on either of these projects can be shared until later in 2024.”

The financials for this partnership were not disclosed.