Reprocell Co., Ltd. Notice of conclusion of basic agreement with BioBridge Global

Reprocell Co., Ltd.
Notice of Conclusion of Basic Agreement with BioBridge Global Establishing a series of processes from provision of iPS cells for clinical use to manufacturing of investigational drugs

We are pleased to announce that our company and BioBridge Global (San Antonio, Texas, USA, hereinafter referred to as BBG Group) have signed a basic agreement to strengthen our strategic relationship.
Under this agreement, the Company will start collaborating with the BBG Group to further enhance its iPS cell-based regenerative medicine programs and contract manufacturing services that it provides to biopharmaceutical companies around the world for their clinical programs and investigational drug manufacturing. It will be. Currently, ReproCELL manufactures iPS cells suitable for clinical use ( Seed iPS cells) are manufactured, and these seed iPS cells (StemRNA(TM) Clinical iPSC Seed Clones) are evaluated by many biopharmaceutical companies around the world.
Through this alliance, we will utilize the seed iPS cells produced by our company, work with BBG subsidiary GenCure as a partner, conduct process development and manufacturing optimization, and provide cGMP (Current GMP) manufacturing services (master cell bank, working cell bank, investigational drug manufacturing, etc.). GenCure’s
manufacturing facilities are designed to meet US, European and Japanese regulatory standards.
It will also be able to offer safety and quality control assays for cGMP manufacturing through QualTex Laboratories, another subsidiary of the BBG Group.
Shuji Yokoyama, President and CEO of our company, said, “Through this partnership, we will be able to expand our business from StemRNA(TM) Clinical iPSC Seed Clones of our seed iPS cells to the manufacture of investigational drugs, which is one of the goals of our clients’ clinical development programs. We are now able to provide a one-stop solution for the cGMP manufacturing flow and the accompanying safety and quality control assays.In partnership with the BBG Group, we are supporting a global regenerative medicine program using our iPS cell technology. We are pleased to be able to accelerate.”
Becky Capp, Chief Operating Officer of GenCure said, “ReproCell’s iPS cell business in the clinical area is our mission to save lives and improve people’s lives through the healing power of human cells and tissues. It resonates strongly with our purpose, and as a company that provides products and services from donors to patients, we are grateful for the opportunity to be a part of this pioneering effort.” About iPS cell production for clinical use
Regenerative medicine development is a time-consuming and costly process requiring strict adherence to manufacturing and regulatory standards that vary by regulatory agency in each country. We manufacture iPS cells for clinical use in compliance with the regulatory standards and guidelines of the US FDA, European EMA, and Japanese PMDA. We also provide a GMP-iPS cell master cell bank as a contract service using the highly safe RNA reprogramming method. Manufactured after obtaining informed consent to enable commercial use, it can also be used for manufacturing after manufacturing and marketing approval.
For details, please visit the website below.
https://reprocell.co.jp/gmp-ips
About BioBridge Global
BioBridge Global (BBG) is a non-profit advanced therapeutics company based in San Antonio, Texas, USA, offering a wide range of services through its subsidiaries The Blood & Tissue Center Foundation, GenCure, Inc. and QualTex Laboratories. The BBG Group provides products and services, donor recruitment, a wide range of blood and tissue sample collection, processing and manufacturing support, donor and finished product testing to customers worldwide. The BBG Group is committed to saving and improving lives through the healing power of human cells and tissues, providing access to human cells and tissues, laboratory services, biomanufacturing and clinical trial support. By doing so, we aim to develop the field of regenerative medicine. For details, please visit the website below.
https://biobridgeglobal.org/
About GenCure
GenCure, a subsidiary of BioBridge Global, provides process
development and optimization expertise and cGMP manufacturing services to advanced cell-based therapeutics developers. The company, along with its sister companies, provides critical support for donor-patient services, including clinical practice standards, access to starting materials, laboratory services, research and development, and clinical research support.
For details, please visit the website below.
https://biobridgeglobal.org/products-and-services/biomanufacturing/ About Qualtex Laboratories
QualTex Laboratories is a non-profit testing agency based in Texas and Georgia, USA. We provide state-of-the-art biological testing services for whole blood, plasma, human cells and tissues for our biotechnology and biopharmaceutical customers.
For details, please visit the website below.
https://biobridgeglobal.org/products-and-services/testing-services/ Details about this release:
https://prtimes.jp/main/html/rd/p/000000003.000099302.html


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