On the occasion of its third aniversary, the biobank which integrated CREAPHARM GROUP as CREAPHARM BIOSERVICES, got its Manufacturer’s Authorisation from the French National Agency for Medicines and Health Products (ANSM*) on August 21th 2023.
With a surge of 222 groundbreaking clinical trials launched in 2022 (1), the Cell & Gene Therapy (C>) sector continues to gain momentum. As a vital pillar in this transformative landscape, CREAPHARM BIOSERVICES has achieved a remarkable milestone. The rigorous scrutiny conducted by the French Regulatory Authorities (ANSM) during file assessment has underscored CREAPHARM BIOSERVICES’ unwavering commitment and strict adherence to Good Manufacturing Practices (GMP). This achievement paves the way for CREAPHARM BIOSERVICES to extend its services, positioning itself as a key player in the storage, pharmaceutical packaging, QP-Release, and distribution of both investigational and market-approved Advanced Therapy Medicinal Products (ATMPs).
Since 2020, CREAPHARM has provided pharmaceutical laboratories, biotech companies and research centers with ultra-secured biostorage solutions, from -196°C to ambient temperature. For 17 years, Frédéric Malboze has been an expert in cryopreservation and was a founder of this first French biobank. Thanks to his team and state-of-the-art facilities, he is going to optimize the complex supply chain for new-generation biomedicines.
“Our focus on patient care and safety is paramount. This Manufacturer’s Authorization exemplifies our dedication to ensuring that patients receive Cell & Gene therapies with the utmost efficiency and reliability.”
“This authorization testifies to the CREAPHARM BIOSERVICES’ commitment to adhere to GMP standards, ensuring the quality and reliability of products at every stage of the supply chain. By combining comprehensive traceability with a risk-based approach, we ensure the effective and secure management of Cell & Gene therapy medicinal products, thereby contributing to ensuring broader patient access to these new therapies.”