This first manufacturing unit is set up, according to the European and the FDA guidelines; it allows the production of clinical batches and will allow for the manufacture of commercial batches on an industrial scale, the company said.
Yann Godfrin, co-founder and CEO of ERYtech Pharma, said: “It is exceptional, especially for a four-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.”