Authorized GMP facility for Manufacturing Clinical Grade Products

Histocell's newly built 600 m² GMP facility is already authorized and registered by the European Union Manufacturer Authorization (EMA) for the manufacturing of clinical grade cells in compliance with the GMP guidelines of EMA Regulation (EU) 2017/1569.

Advanced Therapy Medicinal Products (ATMPs) Manufacturing

Since 2011, Histocell has been an authorized provider of GMP ATMPs manufacturing services to clients around the world.

Around 300 patients have already been treated with ATMPs manufactured by Histocell, and more than 350 batches have been manufactured under GMP.

Advanced Therapy Cell Production Facilities

Histocell's new Advanced Therapies GMP cell production unit has more than 600 m² of capacity.

• GMP manufacturing suites and associated infrastructure
• Fully equipped to manufacture both autologous and allogeneic therapies
• Manufacturing and storage for cell therapy stocks (MCB, WCB)
• Production and characterization of cell-derived biologics such as secretomes and exosomes
• Manufacturing capability: approx. 1200 batches/year
• Designed to support both pre-clinical and clinical phases
• Histocell is also gearing up to support commercial manufacturing