Manufacturer of human induced pluripotent stem cells, RheinCell Therapeutics, announced it has received Good Manufacturing Practice (GMP) certification and Manufacturing Authorization.
This marks a landmark achievement for RheinCell Therapeutics, which is now among a select few iPSCs manufacturers to have received the critical certification.
The certificate and accompanying manufacturing permit — which were granted following inspection of RheinCell’s manufacturing facilities in September 2020 — confirm that the company’s site follows the GMP principles of the European Union for human medicinal products (2003/94/EC), including requirements for chemical, physical, and biological quality control testing.
“We have reached another milestone in the evolution of our company – one that was borne from the foresight of our manufacturing and quality control teams, and the tremendous work of everyone involved in building an efficient production strategy,” said Jürgen Weisser, CEO of RheinCell. “RheinCell is now one of very few commercial enterprises worldwide that are certified to produce iPSCs – a critical starting material for stem cell-based therapies – in a regulated and GMP-compliant process and environment.”
Heading up the certification efforts was Dr. Katja Aschermann, COO of RheinCell. “At RheinCell, we are proud to implement state-of-the-art, GMP-compliant manufacturing processes to meet the needs of our international customers for ready-to-use, fully characterized clinical-grade iPSC lines,” explained Aschermann.
The GMP certification and Manufacturing Authorization pave the way for the company to deliver fully characterized clinical-grade iPSCs that are derived from human cord blood cells for the development of cell-based therapies. Furthermore, RheinCell has the technology, facilities, know-how and processes to manufacture, expand, differentiate and cryopreserve these cell lines according to specific development needs.