At the 5th Annual Membership Meeting in March 2020, MTEC recognized two member organizations who have displayed outstanding technical progress related to their MTEC awards.
Congratulations to GenCure, a subsidiary of BioBridge Global, in collaboration with StemBioSys, RoosterBio, and the US Army Institute of Surgical Research!
This team recently completed their MTEC scope of work and made a number of outstanding accomplishments related to stem cell biomanufacturing. These cells can benefit both military and civilian regenerative medicine applications by accelerating the clinical translation of cell-based therapies and tissue engineering technologies. Some highlights from their work include:
- Developed and commercialized a product – a mesenchymal stem cell (MSC)-specific, xeno-free bioreactor feed
- Scaled up to a 50L xeno free batch-fed microcarrier expansion system for human bone marrow-derived MSCs and developed a process for closed system harvesting of the cells
- Developed a fill system and cryopreservation process for bone marrow-MSCs
- Able to produce xeno-free clinical grade 15 million human BM-MSC (>200,000 cells per ml of culture) in a GMP environment and perform all relevant testing required
Congratulations to Critical Innovations!
The team is working on a F.O.A.M.™ designed to control severe intra-abdominal bleeding in critically ill trauma patients, when surgical intervention is not immediately available. Once delivered into the body via a specialized auto-stopping needle, its foaming agent expands and exerts pressure. Its main polymer component is unusual in that it exhibits reverse-phase-shift properties, meaning it becomes more solid at warmer temperatures (e.g. body temperature). It is also thermoreversible, so if a subsequent surgical procedure is required, a surgeon can reverse the process and wash it away with room-temperature liquid. However, if no further procedure is needed, the foaming agent gradually dissolves to be cleared by the body within a few days. The program has been a success to date, having met or exceeded all program deliverables, achieved Breakthrough Device Designation from the FDA, and delivered very encouraging porcine study survival data. Critical Innovations is currently transitioning the device to large-scale manufacture while refining its noncompressible intra-abdominal hemorrhage live-animal model based on FDA feedback and is advancing closer to regulatory submission.