Pluristyx, Inc., an advanced therapy tools and services biotechnology company, and Accelerated Biosciences, a regenerative medicine innovator in the use of proprietary human trophoblast stem cells (hTSCs), today announced they signed an agreement for Pluristyx to manufacture clinical grade hTSC banks under Good Manufacturing Practices (GMP). Accelerated Biosciences will use and make these stem cell banks available to commercial partners for further manufacturing of advanced biologic and cellular therapies. hTSCs have unique legal, ethical, and intellectual property advantages, including a high expansion capacity and a unique genetic identity not associated with any person or embryo, making them the ideal starting material for manufacturing the next generation of advanced therapies.
“We are gratified by Accelerated Biosciences choice of Pluristyx as their CDMO partner for GMP manufacturing. We are excited to be manufacturing clinical-grade cell banks for use as a unique starting source for the next generation of cell-based advanced therapies. This work demonstrates our commitment to providing the highest quality cells today for clinical development of tomorrow’s novel advanced therapies,” said Dr. Benjamin Fryer, Chief Executive Officer of Pluristyx.
Yuta Lee, Chief Executive Officer of Accelerated Biosciences, stated: “We recognized early on that there is an unmet need for an ethical, clinical-grade, pluripotent stem cell source with complete regulatory compliance documentation from donor consent to GMP release. To meet this need, we aim to make the hTSC source readily available to industry partners in order to accelerate cures to market. We are grateful to the dedicated team at Pluristyx for making this complex process simple. We look forward to doing our part to advance the cell and gene therapy industry.”
Pluristyx is a privately held biotechnology company offering consulting, wet-lab and GMP banking services, and pluripotent stem cell products to support novel therapeutic developers. Pluristyx helps industry and academic researchers solve manufacturing and analytical challenges in cryopreservation, drug development, regenerative medicine, and cell and gene therapy. The Pluristyx team has decades of experience supporting every stage of cell therapy product development, from cell banking to drug product manufacturing including analytical testing and release of clinical grade cell therapy products.
About Accelerated Biosciences
Accelerated Biosciences is a private regenerative medicine company focused on commercializing the hTSC platform, discovered by physician and researcher, Professor Jau-Nan Lee, MB, MD, PhD. Accelerated Biosciences holds a proprietary source of hTSCs with a robust intellectual property (IP) estate. Accelerated Biosciences’ mission is to leverage its renewable, immune-privileged human cell source to accelerate cures to patients and to make gene and cell therapy affordable to all in need.