ERYtech Pharma has developed a competitive industrial process under EMEA and FDA rules. It has been audited and authorized by AFSSAPS.

The process requires specific automatized machines with single use kits. It takes few hours of production and quality control to release the product.

No modifications of the characteristics of the red cells have been observed during a Phase I/II clinical trial. The cells maintain the same half life and same phenotype (antigen surface).

Production site in Europe

The 500 sqm cGMP facilities are set up in Lyon under the EMEA rules to cover the European market.

ERYtech Pharma complies with regulatory and legal frameworks and has been awarded ISO9001:2008 Certification.

Production site in US

ERYtech Pharma has an agreement with the American Red Cross of Penn Jersey Region concerning the GMP clinical batches production of ERYtech Pharma’s products.