August 2020 – InoCells ATMP Manufacturing to be set up at Medace
The Dutch start-up company InoCells has developed a unique stem cell therapy to rejuvenate the ovary of infertile patients whose ovaries have low quality and quantity of eggs. Their stem cell therapy will provide this patient population a high chance to become pregnant with their own biological child.
The regulatory strategy and manufacturing for clinical trials for this infertility stem cell therapy are already approved outside the European market. Now, InoCells wishes to enter the European market. Medace will aid InoCells in the gap analysis towards European approval and to develop their quality and regulatory strategy. The ultimate goal is to receive a manufacturing license for the European market.
Jessica Gerards, ATMP Quality Assurance Manager at Medace is looking forward to the collaboration:
‘I am happy with the swift start of the collaboration between InoCells and Medace. Our expertise together with the trust of InoCells made it possible to complete the ATMP classification request to the European Medicine Agency (EMA) within the European set deadline.’
Prof. Mohammad Mehdi Akhondi, Director at InoCells is enthusiastic about the offerings of Medace:
‘We are excited to setup our ATMP manufacturing at the Medace facilities. Their innovative business model which reduces risks and large investment suits InoCells best . Medace’s products and services such as lab facilities, GMP-ready clean rooms, quality management & regulatory support and its network with key partners, enables InoCells to reduce its time to market. InoCells is looking forward to a long-term collaboration with Medace.’