GenCure, StemBioSys Forge Stem Cell Product Manufacturing Agreement

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GenCure will be exclusive producer for StemBioSys-developed regenerative medicine products

BioBridge Global will be the exclusive manufacturer for cell-based products that StemBioSys has developed or co-developed with GenCure.

"As we continue to grow our business with our existing and new products, having GenCure for a partner will ensure we can meet the regulatory and quality needs of our customers around the world.” - StemBioSys CEO Bob Hutchens.

GenCure, a subsidiary of San Antonio-based nonprofit biotech BioBridge Global, has entered a development and manufacturing agreement with stem cell technology developer StemBioSys Inc. of San Antonio.

In the agreement, GenCure will be the exclusive manufacturer for cell-based products that StemBioSys has developed or co-developed with GenCure. The agreement expands on the work GenCure and StemBioSys have done on single cell lines.

The $7.8 million Medical Technology Enterprise Consortium (MTEC) contract awarded in October to BioBridge Global, StemBioSys, Maryland-based RoosterBio Inc. and the U.S. Army Institute of Surgical Research (USAISR) Coagulation and Blood Research is driving this further collaboration around cell expansion in a xeno-free (animal-product free) model, said Becky Cap, GenCure chief operating officer. Xeno-free therapies are preferable to cell therapeutics that use bovine-derived materials. In the collaboration with StemBioSys, GenCure exclusively procures and works to expand noncontroversial stem cells from donated umbilical cord blood and birth tissue.

“This agreement with our associates at StemBioSys is one more step in GenCure’s long-term goal to function as a premier biomedical contract development and manufacturing organization,” Cap said. “It helps establish GenCure’s position in the regenerative medicine space where we leverage the benchtop work of a large group of researchers using GenCure’s quality and regulatory expertise and extensive history of working with cell-based products.”

Cap added the agreement provides GenCure with the opportunity to use cord blood cells from donations that are not large enough to meet the clinical standards for transplant to support development of new regenerative medicine-based therapies that save and enhance lives in South Texas and around the world.

The agreement engages BioBridge Global’s unique operational assets such as research and development, biologic testing, raw source material and nearly 4,000 square feet of FDA-regulated cGMP (Current Good Manufacturing Practice) lab space.

“This is an important agreement for StemBioSys. As we continue to grow our business with our existing and new products, having GenCure for a partner will ensure we can meet the regulatory and quality needs of our customers around the world,” StemBioSys CEO Bob Hutchens said. “Our ongoing work with GenCure is exploring a number of areas within regenerative medicine. We’re excited about the results we’ve already seen in this collaboration and look forward to announcing some of the results of this work in the near future.”

GenCure and StemBioSys’ collaborative efforts over the years have focused on utilizing donated umbilical cord blood and birth tissue – both sources GenCure collects from donors – to develop regenerative medicine products.

About GenCure: GenCure, a subsidiary of Texas nonprofit BioBridge Global, focuses on regenerative medicine and uses the power of human cells and tissues to inspire hope, enhance lives and enable clinical advancements. Using processed tissue and cell-based therapies, GenCure works to connect health care requirements with innovative solutions that best serve the needs of the global patient community.

About StemBioSys: StemBioSys Inc. is a privately held San Antonio-based biomedical company that manufactures and develops innovative, advanced stem cell technologies to meet the promise of regenerative medicine in a surging global market. Its patented and proprietary technology platforms – licensed from the University of Texas System – overcome key obstacles to creating clinically useful stem cell therapies.

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