RheinCell Therapeutics, a developer and manufacturer of human induced pluripotent stem cells (iPSCs) as starting materials for cell therapies, has received Good Manufacturing Practice (GMP) certification and Manufacturing Authorization. This marks a landmark achievement for RheinCell, which is now among a select few iPSCs manufacturers to have received the critical certification.
RheinCell Therapeutics offers fully characterized clinical-grade iPSCs for cell therapy development and commercialization.
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.
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.
For more information, visit: www.rheincell.de