REPROCELL Inc. and San Antonio, Texas-based BioBridge Global have signed a Memorandum of Understanding to enhance their strategic collaborative relationship.
The agreement will expand REPROCELL’s global biomanufacturing service using induced pluripotent stem cells for clinical and therapeutic purposes of its clients.
Currently, REPROCELL manufactures iPSCs that are suitable for therapeutic use and compliant with the key regulatory standards stipulated by the U.S. Food and Drug Administration, European Medicine Agency and Japan’s Pharmaceuticals and Medical Devices Agency.
The seed iPSCs (StemRNA™ Clinical iPSC Seed Clones) have been evaluated, approved and employed by numerous biopharmaceutical clients.
BioBridge Global, through its subsidiary GenCure, provides process development and optimization expertise, as well as cGMP manufacturing services. The GenCure production facility is designed to be compliant with regulatory standards for the United States, Europe and Japan. The collaboration will expand REPROCELL’s biomanufacturing service, allowing extension of projects using REPROCELL’s StemRNA™ Clinical iPSC Seed Clones to the investigational new drug manufacturing phase.
QualTex Laboratories, another subsidiary of BioBridge Global, will provide safety and quality control assays relating to the manufacturing of GMP iPSC master cell banks and working cell banks, as well as IND manufacturing.
The partnership will accelerate global stem cell-related business using REPROCELL’s StemRNA™ Clinical iPSC Seed Clones.
“We are thrilled to partner with BioBridge Global and its subsidiaries to support and accelerate global regenerative medicine programs using iPSCs for our clients” said Chikafumi Yokoyama, Chief Executive Officer of REPROCELL Inc.
“The work that REPROCELL is doing in the therapeutic space with iPS cells resonates strongly with our focus on saving and enhancing lives through the healing power of human cells and tissue,” said Becky Cap, Chief Operating Officer, GenCure. “Being that donor-to-patient provider of products and services, we appreciate the opportunity to be part of this pioneering effort.”