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, GenCure.
The harvest was the first series of runs in which a 50-liter batch of 1.2 billion bone-derived hMSCs were expanded into 20 billion within a 10-day timeframe. Two 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, 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 to develop and implement the process, which 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.
The bioreactor test runs come ahead of BBG’s expansion of the GenCure biomanufacturing facility at the VelocityTX innovation center in San Antonio, TX expected to be complete in the fourth quarter of 2019. As the anchor tenant, the nonprofit will lease 21,000 square feet of biomanufacturing space.
“As the anchor tenant of the VelocityTX accelerator program, we are expanding the manufacturing capabilities of GenCure and the cell therapy industry,” said Ms. 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.