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news.Ferring Pharmaceuticals and SK pharmteco have entered into an agreement to increase commercial manufacturing capacity for Ferring’s ADSTILADRIN (nadofaragene firadenovec-vncg), ensuring a long-term supply of the non-replicating adenoviral vector-based gene therapy.
Ferring’s ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy. Credit: Furiosa-L from Pixabay.
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This partnership follows the US Food and Drug Administration’s approval of ADSTILADRIN in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
After technology transfer, SK pharmteco, a contract development manufacturing organisation (CDMO), will be responsible for manufacturing, testing, and release of the drug substance, subject to US FDA regulatory approval.
The collaboration aims to diversify the supply and meet anticipated commercial growth.
SK pharmteco CEO Joerg Ahlgrimm said: “SK pharmteco is proud to partner with Ferring Pharmaceuticals as a manufacturer of the breakthrough gene therapy ADSTILADRIN.
“Our integrated approach, incorporating customizable clinical and commercial GMP manufacturing solutions with comprehensive in-process testing, quality control, and lot release programmes, provides unparalleled support to our partners throughout their product lifecycle and is in perfect alignment with our mission of expediting the delivery of potentially life-saving therapies to patients across the globe.”
Ferring is also expanding dedicated capacity at its facilities in Finland and the US, to meet the increase in demand for the therapy.
Last year, Ferring Pharmaceuticals entered into a research and development (R&D) partnership and licensing agreement with PharmaBiome to develop new microbiome-based therapies in gastroenterology.
