REPROCELL's solution for GMP iPSC development - Seed iPSC Manufacturing Suite
29 June 2021
Maryland, USA: REPROCELL has opened a new Seed iPSC Manufacture Suite (SiMS) in response to increasing demand for iPSC-derived Master Cell Banks (MCBs).
At this new US facility, REPROCELL will provide a comprehensive workflow of clinical stem cell services starting from donor tissue collection to establishment of iPSCs - the seed iPSC stocks which will be the source for the GMP iPSC MCBs. By conducting these procedures in the clean room facility of SiMS, iPSCs are manufactured at a high level of safety, and by following the guidelines of the FDA (USA), the EMA (EU), and the PMDA (Japan).
“The establishment of REPROCELL's SiMS is an important milestone. In recent years, the movement toward clinical application of iPSC has been particularly active in the USA, Europe, and Japan,” said Chika Yokoyama, REPROCELL’s CEO. “Our offering is unique because we use RNA reprogramming: a footprint-free, virus-free reprogramming methodology,” he continued.
“We have established a manufacturing and management system that can respond to the increasing demand from around the world for the establishment of GMP iPSC for clinical and therapeutic use," said Rama Modali, REPROCELL USA's CEO. "We are happy to offer solutions for those who aim to develop and use the GMP iPSC for their therapeutic projects with the regulatory compliance with FDA, EMA and PMDA" he continued.
Induced pluripotent stem cells, or iPSCs, are stem cells generated from the tissue of adult donors. Because these cells are created from the donor's own tissue, they carry a reduced risk of transplant rejection and do not possess the same ethical concerns as embryonic stem cells. RNA reprogramming is a safe, effective way of generating iPSCs because it does not integrate with the donor DNA during the reprogramming process and is virus-free.