This first manufacturing unit is set up, according to the European and FDA guidelines ; it allows the production of clinical batches and will allow for the manufacture of commercial batches on an industrial scale.

 

“It is exceptional, especially for a 4-year company which develops innovative pharmaceutical products, to reach the best international standards of quality, reproducibility and safety. In our field, this authorization is the first one, as far as I know. This is the recognition of the skills and expertise of  the team.” Says Dr Yann Godfrin, Co-founder & CEO of ERYtech Pharma.

 

“We will be in operational situation to manufacture our medicinal products within two hours. This authorization is an essential step on the way of the future commercialization of our products” concludes Pierre-Olivier Goineau, Co-founder, COO in charge of the business development.

 

 

About ERYtech Pharma (http://www.erytech.com/)

 

ERYtech Pharma is a specialty pharma company developing a new generation of drugs. GRASPA®, its most advanced product, has achieved its Phase II clinical trial in Acute Lymphoblastic Leukemia.

A pioneer in the encapsulation of therapeutic molecules into red blood cells, ERYtech Pharma is developing a pipeline of innovative therapeutic solutions based on its proprietary technology and expertise in the physiological properties of erythrocytes. The company addresses serious pathologies, orphan indications or sub-populations of patients, particularly in the fields of haematology, cancer and metabolic diseases.