MTEC selects BioBridge Global as recipient of Prototype of the Year Award

Recognition due to advancing large-scale manufacturing capabilities for clinical-grade adult stem cells for research and new therapies
March 10, 2020
80L-bioreactor-stemcells

BioBridge Global has been named one of two Prototype of the Year Award winners by the Medical Technology Enterprise Consortium (MTEC) for work done following a $7.8 million MTEC grant for the development of large-scale manufacturing capabilities for clinical-grade adult stem cells.

The award was presented at the MTEC Annual Meeting on March 4.

“This award recognizes flawless execution – on-time or ahead of schedule and on-budget for all milestones,” said Becky Cap, Chief Operating Officer of GenCure. “Getting to this point with four collaborators is a huge acknowledgement of excellence both for our execution teams and the supporting groups who worked through billing and reporting requirements.”

The work led to the development of new capabilities and services at the GenCure biomanufacturing facility, which will provide stem cells for research and eventually for new therapies. The facility is scheduled to open later this month at the Merchants Ice complex east of downtown San Antonio.

“The MTEC grant funded not just the development of new capabilities – it launched a whole line of services that will support the development of new therapies for wounded warriors and civilian patients,” Cap said.

BioBridge Global led the group that received the original contract, which also included the U.S. Army Institute of Surgical Research Coagulation and Blood Research, San Antonio biotech firm StemBioSys and Maryland-based RoosterBio Inc., working toward standardizing hMSCs.

As research on potential cell therapies grows, access to large volumes of consistent cell material for testing in clinical trials addresses a critical need to move potential new therapies from early phase to late phase clinical trials and commercialization.

The goals of the three-year collaboration were moving hMSC production into an 80L stir-tank bioreactor format offered by PBS and identifying critical assays for product use by therapeutic development companies.

Achieving scale while maintaining critical quality attributes is critical to developing cost-effective products and related services for use in regenerative medicine, Cap said. GenCure and its sister subsidiary QualTex Laboratories were responsible for moving these developed capabilities to GMP-readiness. GenCure now offers manufacturing services to therapeutic developers moving into clinic under an IND, while QualTex offers a robust menu of testing services.

MTEC is a nonprofit corporation created by the U.S. Army’s Medical Research and Materiel Command to collaborate with companies, universities, foundations and other entities to develop medical technology solutions through flexible and innovative business practices.