YOKOHAMA, Japan: 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 the 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 the 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.”
About REPROCELL’s iPSC generation suitable for therapeutic programs: Developing cellular therapies is a time-consuming and costly process. It requires strict adherence to manufacturing and regulatory standards that are different for each national regulatory agency. REPROCELL manufactures GMP iPSC MCBs that are compliant with the regulatory standards and guidelines of the FDA, EMA, and PMDA.
Through our clinical network, we can procure the tissues needed for the therapeutic program and perform the necessary viral and donor profile screenings compliant with key regulatory agencies. After deriving a primary fibroblast primary culture, we use our proprietary footprint-free RNA reprogramming technology to generate a clinical grade iPSC seed stock (StemRNA™ Clinical iPSC Seed Clones). Under strict quality control measures, these StemRNA™ Clinical iPSC Seed Clones are expanded in a GMP environment to manufacture a Master Cell Bank. REPROCELL’s GMP iPSCs are suitable for commercial and therapeutic programs, subject to a simple one-time commercial and therapeutic license without any limitation of therapeutic fields.
Learn more at reprocell.com/clinical-stem-cell-sercices.
About BioBridge Global: BioBridge Global (BBG) is a San Antonio, Texas-based 501(c)(3) nonprofit advanced therapies enterprise that offers diverse services through its subsidiaries – South Texas Blood & Tissue, QualTex Laboratories, and GenCure. BBG provides products and services, donor recruitment and sample collection for a wide range of blood and tissue types, processing and manufacturing support, and testing of both donor and finished products for clients in the United States and worldwide. BBG is committed to saving and enhancing lives through the healing power of human cells and tissue. It enables advances in the field of regenerative medicine by providing access to human cells and tissue, testing services and biomanufacturing and clinical trials support.
Learn more at BioBridgeGlobal.org.
About GenCure: GenCure, a subsidiary of San Antonio-based nonprofit BioBridge Global, provides process development and optimization expertise and cGMP manufacturing services for cell and cell-based advanced therapies companies as the anchor tenant for the VelocityTX landmark biotech innovation corridor complex. Working with its sister subsidiaries, GenCure understands and provides support for donor-to-patient services with a foundation in the critical elements related to clinical practice standards, access to starting materials, testing services, research and development, and clinical research support.
Learn more at GenCure.org.
About QualTex Laboratories: QualTex Laboratories provides state-of-the-art biologic testing services on whole blood, plasma and human cells, tissue, and cellular- and tissue-based products for biotechnology and biopharmaceutical customers. It is one of the nation’s largest nonprofit testing laboratories with automation systems and has locations in Texas and Georgia. The laboratory is a subsidiary of BioBridge Global, a nonprofit organization comprising services for regenerative medicine and research to help patients in South Texas, the United States and worldwide. Visit us at qualtexlabs.org.