European manufacturing facility to strengthen gene therapy supply

Ferring Pharmaceuticals has opened a new European manufacturing site focused on supporting production for one of its gene therapies to treat non-muscle invasive bladder cancer (NMIBC).

The global manufacturing hub in Kuopio, Finland will bolster supply of the drug substance of its gene therapy Adstiladrin^® (nadofaragene firadenovec-vncg).

The treatment is the first and only US Food and Drug Administration (FDA)-approved intravesical non-replicating gene therapy for adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

The 25,000m² facility contains a manufacturing suite boasting modern technology to enable large quantities of the drug substance to be produced. Renewable energy solutions are also key features of the site. These include “waste heat recovery with heat pumps and solar energy”, the company stated.

Promise of AAV-based gene therapies

This development aligns with the continued industry support of AAV gene therapies.

Touting their potential, when asked what gene therapy modality he considered to be most promising, Roger Palframan, Head of US Research at UCB selected AAVs. “Compared to other delivery technologies, AAV stands out for its proven ability to deliver payloads to target cells, favourable tolerability profile and for its durability meaning treatments have long-lasting beneficial effects”.

For example, Dr Maria Escolar, Chief Medical Officer, Forge Biologics explained that “a distinguishing factor of AAVs compared to other delivery methods for gene therapies is low incidence of toxicity in humans”.

Strengthening the supply chain

Launch of Ferring’s new facility in Finland “marks an important milestone in ensuring stable and sustainable global supply of Adstiladrin^® to meet the anticipated growth in demand,” stated Bipin Dalmia, Global Head, Uro-Oncology and Urology Franchise, Ferring Pharmaceuticals.

Furthermore, a new drug product manufacturing facility at its campus in Parsippany, New Jersey in the US has nearly completed construction, Ferring reported.