Histocell and Sant Joan de Déu Hospital join forces to manufacture acvanced therapies medicinal products

Basque biotech company Histocell and Barcelona’s Hospital Sant Joan de Déu (HSJD) have signed a collaboration agreement to offer CDMO manufacturing services for advanced therapy medicinal products to any public or private organisation in Spain. The alliance covers CAR-T-based gene therapy, cell therapy and therapies involving associated biologics, such as secretomes and exosomes. Its aim is to increase the clinical impact of these therapies by combining the teams, facilities and structures of both organisations.

Two manufacturers with MIA numbers

The agreement follows the granting of a Manufacturing and Importation Authorisation (MIA) to HSJD’s advanced therapies platform, recognising it as a pharmaceutical manufacturing laboratory. This authorisation enables it to manufacture gene therapy products based on autologous T lymphocytes. The milestone places the hospital on an equal footing with any private company or CDMO manufacturing CAR-T medicines for clinical or commercial use.

Histocell is a manufacturing laboratory authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS), holding an MIA number, and with GMP certification since 2011. It operates as a CDMO and currently has the largest facility in Spain in its field, with seven cleanrooms for manufacturing cell therapy medicinal products and associated biologics.

A portfolio covering most new therapies

The collaboration brings together two organisations with unique capabilities in Spain. Combined, their technologies, facilities and expertise encompass most new therapies that patients and both public and private healthcare systems may need, in Spain and beyond.

The alliance will enable both organisations to take on national and international projects more quickly and competitively.