StemExpress GMP Manufacturing
At StemExpress we understand the importance of GMP compliance for our clients. As such, we ensure that your source materials are of the highest quality from the moment they are collected. StemExpress adheres to rigorous FDA guidelines to ensure GTP compliant tissue procurement by highly trained professionals with our state-of-the-art devices. Partner with StemExpress for ready access to targeted, sterile, uncontaminated products for your GMP-compliant human cellular therapies.
COMPLIANT WITH ALL OF YOUR RESEARCH NEEDS
StemExpress supports our biomedical partners by meeting their significant need for high quality starting material for the development of autologous and allogeneic cell-based therapies. Our GTP tissue collections meet the rigorous FDA 1271 guidelines, ensuring reliable cell collection, isolation, processing and storage. Let us be your partner in providing exceptionally high-grade source material for your cell-therapy research, from development to commercialization.
WE OFFER GMP CELL ISOLATION
Do you need a tissue procurement partner that can also perform GMP cell isolation? Look no further! StemExpress has two BioSpherix units at our state-of-the-art Folsom, CA laboratory. Our fully enclosed, self-contained BioSpherix devices operate with a continuously HEPA filtered ISO 5 processing system, guaranteeing sterility and GMP-compliant cells.
PARTNER WITH US
Whether you need GTP starting material for your human cell therapies, GMP-compliant cell isolation, or cryopreserved Leukopaks®, StemExpress is here to meet your needs. We welcome our cell therapy and GMP clients to contact us and schedule an on site audit of our cutting-edge laboratory facilities.
- Cell isolation protocols
- Cell collection protocols
- Cell-based equipment testing
- Blood and specimen kit development
- Research and clinical device development
- Cold chain shipping logistics
- Cell culture
- Custom vialing and cell counts
- Mobilization process
- Media and anticoagulants
- Shipping requirements