The 25,000 square meter facility includes a manufacturing suite to produce adenovirus vector-based gene therapy DS for Adstiladrin (nadofaragene firadenovec-vncg). The scale-up was announced in June 2023 after a US Food and Drug Administration (FDA) approval.
Additionally, the firm is also nearing completion of a manufacturing facility for drug product (DP) at its campus in Parsippany, New Jersey. According to the spokesperson, this is a fill/finish plant focused on final drug product (DP) manufacturing.
“Larger-scale production at this facility is expected to commence within the coming years, pending FDA and other necessary approvals,” a spokesperson for Ferring told BioProcess Insider.
“The unit will incorporate sustainable energy solutions, including solar energy utilization and waste heat recover. We are applying for the Leadership in Energy and Environmental Design (LEED) environmental certificate for the sustainable development of construction for its new unit.”
Adenovirus vector-based gene therapy Adstiladrin was approved by the FDA in 2022 as the first gene therapy for bladder cancer. The intravesical non-replicating gene therapy is administered locally as a monotherapy by catheter directly into the bladder every three months. It targets the patient’s own bladder wall cells to enhance the body’s natural defenses to fight cancer. In January 2024, the firm announced full commercial availability of Adstiladrin in the US.
“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,” said Armin Metzger, chief technical operations officer, Ferring Pharmaceuticals.
Ferring partnered with contract development and manufacturing organization (CDMO) SK pharmteco to scale up commercial-manufacturing capacity for the DS used in Adstiladrin in April 2024. The agreement included a technology transfer of the adenoviral vector-based gene-therapy DS for the manufacturing process, and analytical test methods for release and stability testing.
You May Also Like
