Day: January 22, 2020

With baseline studies close to completion, the GenCure Biomanufacturing facility at the VelocityTX innovation center is on track to be fully operational in the first quarter of 2020. The cGMP-compliant, contract manufacturing facility allows GenCure, a subsidiary of BioBridge Global, to scale up production of adult stem cells, providing critically needed support to researchers and organizations looking to move potential therapies from early phase to late-phase clinical trials, and on to commercialization.

BioBridge Global is leasing 21,000 square feet in the VelocityTX center as part of the second phase of its GenCure Biomanufacturing program, initially launched in January 2018. The space includes 6,700 square feet of clean-room production space, a 2,500 square-foot process development lab, and office and meeting space. The facility also includes an additional 8,000 square feet for expansion as GenCure’s client base grows and more space is needed for production.

The biomanufacturing space is an extension to what GenCure and BioBridge Global already are doing—supporting the use of cells and tissue to save and enhance lives. The expansion allows for the production of consistent, clinical-grade adult stem cells on a large scale—stem cells needed to bring potential new therapies through early to late phase clinical trials, and then to be available for routine prescribing.

In August 2019, Gencure announced its biomanufacturing services team successfully expand adult stem cells in an 80-liter bioreactor, becoming among the first contract manufacturing and development organizations to produce MSCs at this scale.

“This is a great step forward in enabling development of new cell-based therapies,” said Becky Cap, Chief Operating Officer for GenCure. “With this bioreactor production scale, you can increase the number of patients treated with a single, consistent production run.”

In addition to contract manufacturing services, BioBridge Global provides development services including process and analytical development, access to quality control testing, a robust quality management system and development of documentation to support regulatory filings.

The GenCure Biomanufacturing facility is the anchor tenant at VelocityTX’s four-acre site, currently being redeveloped into a modern bio- and life-sciences business incubator and innovation center to serve multiple industries and provide a broad array of resources to entrepreneurs. The support for the innovation center from the city of San Antonio and public and private investments demonstrates the city’s commitment to expanding its biomedical sector.

BioBridge Global  has added two new members to its Regenerative Medicine Advisory Board, a group composed of industry leaders with a wide range of scientific, product development and business experience brought together to support the organization’s continued growth in regenerative medicine

BioBridge Global provides a range of products and services in regenerative medicine, including human cells and tissue, testing, and biomanufacturing and clinical services, through its three operating entities: GenCure, QualTex Laboratories and the South Texas Blood & Tissue Center.

The new members of the BioBridge Global Regenerative Medicine Advisory Board are:

• Chris Mason, PhD, Co-founder and Chief Science Officer at AvroBio, a publicly held, clinical-stage, gene therapy company based in Cambridge, Massachusetts. Dr. Mason is a professor of cell and gene therapy at University College London. He also is Senior Editor of the journals Cell and Gene Therapy Insight and Regenerative Medicine.
• Michael J. Yaszemski, MD, PhD, Professor of Orthopedic Surgery and Biomedical Engineering at the Mayo Clinic and director of its Biomaterials and Tissue Engineering Laboratory. Dr. Yaszemski served as Chair of the FDA Center for Devices and Radiologic Health Advisory Committee, and is currently a member of the FDA Science Board. He is a retired U.S. Air Force brigadier general.

Extended biographies are here.

The addition of new advisory board members comes at a time when BioBridge Global is launching the second phase of its GenCure biomanufacturing capacity expansion. The 21,000-square-foot facility will produce the large numbers of consistent, high-quality, clinical-grade adult stem cells needed to help bring potential new therapies into human clinical trials. The center is expected to be completed by the end of 2019.

“With the addition of Chris and Mike, we now have five outstanding industry leaders that will help lead BioBridge Global become a recognized leader in regenerative medicine,” said Martin Landon, Chief Executive Officer of BioBridge Global. “Their invaluable experience and expertise will guide our research and development in breakthrough cellular therapies that ultimately will save and enhance lives.”

The BioBridge Global Regenerative Medicine Advisory Board was formed in 2018 and includes Phil Vanek, PhD, General Manager of GE Healthcare’s Cell and Gene Therapy business strategy; Gregory Bonfiglio, JD, Founder and Managing Partner of Proteus LLC, an investment and advisory firm focused solely on regenerative medicine, and Chairman of the Board of the Centre for Commercialization of Regenerative Medicine in Toronto, Canada; and Kenneth Bertram, MD, PhD, FACP, former commander of the Walter Reed Army Institute of Research and Principal Assistant for Acquisition for the U.S. Army Medical Research and Materiel Command.

In a breakthrough for the regenerative medicine industry, GenCure announced today that its biomanufacturing services team has successfully completed production runs expanding and harvesting human mesenchymal stem cells (hMSCs) in an 80-liter bioreactor. GenCure, a subsidiary of BioBridge Global (BBG), announced a major expansion of its biomanufacturing facilities in February of this year

The move to an 80-liter bioreactor addresses a critical need in the cell therapy industry for producing large-scale, consistent, clinical-grade adult stem cells needed to bring potential new therapies into clinical trials. GenCure is among the first contract manufacturing and development organizations (CDMO) to produce MSCs at this scale.

What sets GenCure apart from many existing cell therapy CDMOs is that, by having stem cell expansion capabilities at this scale, we are able to provide manufacturing and development services from early phase clinical trials through late stage clinical trials and commercialization,” said Mike Fiske, Vice President of Manufacturing with GenCure.

The harvest was the first series of runs in which a 50-liter batch of approximately 1 billion bone-marrow-derived hMSCs were expanded to tens of billions within a 10-day timeframe. Five to seven more runs are planned to refine the manufacturing process.

“This is a tremendous step in advancing new therapies in cell therapy and regenerative medicine,” said Becky Cap, Chief Operating Officer for GenCure. “In cell therapy, you need large numbers of cells per batch to create clinical doses that are consistent to give to multiple patients. With this bioreactor technology, you can increase the number of patients treated with a single, consistent production run, by tenfold.”

GenCure joined with RoosterBio, Inc. to develop and implement the process to cGMP-compliant standards. The process was funded through a three-year, $8.9 million contract from the Medical Technology Enterprise Consortium to develop large-scale manufacturing capabilities for clinical-grade stem cells to be used in research and therapeutic applications. Other collaborators on the project include two San Antonio-based organizations: U.S. Army Institute of Surgical Research and StemBioSys, Inc.

The bioreactor test runs come ahead of BBG’s expansion of the GenCure biomanufacturing facility at the VelocityTX innovation center in San Antonio, expected to be complete in the fourth quarter of 2019. As the anchor tenant, the nonprofit will lease 21,000 square feet of space for process development, manufacturing and additional room for later buildout.

“As the anchor tenant of the VelocityTX accelerator program, we are expanding the manufacturing capabilities of GenCure and the cell therapy industry,” said Cap. “Fulfilling the need to scale up adult stem cells for clinical trials helps advance potential new therapies for a range of diseases and conditions.”

In addition to contract manufacturing services, GenCure and BBG’s subsidiaries provide development services including process and analytical development, access to quality control testing, a robust quality management system and development of documentation to support regulatory filings.