The run hugely scales up human mesenchymal stem cells production with two more runs planned to refine the process
Bt-hMSCs detached from the microcarriers on the day of harvest
In a big step for its regenerative medicine capabilities, GenCure has announced that its biomanufacturing services team has completed a production run expanding and harvesting human mesenchymal stem cells (hMSCs) in an 80-litre 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-litre 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. Texas-based GenCure is among the first CDMOs 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 commercialisation,” said Mike Fiske, VP of Manufacturing at GenCure.
The harvest was the first series of runs in which a 50-litre 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 GenCure, COO. “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, US$8.9 million contract from the Medical Technology Enterprise Consortium. This funding was 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 organisations: US 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 centre in San Antonio, expected to be completed in Q4 2019. As the anchor tenant, the nonprofit will lease 21,000 sqft 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 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.