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.