Importance Of Cellular Therapies
Every day, researchers are using stem cell products to develop life-saving therapies for patients in need. StemExpress provides leading biomedical researchers with the starting material integral to the advancement and development of autologous and allogeneic cell-based therapies. Our state-of-the-art laboratories follow the FDA's stringent guidelines with regard to allogeneic therapies, requiring extensive donor screening, testing and current good tissue practices in an effort to prevent the introduction and transmission of communicable diseases. Whether you’re developing CAR-T therapy, or arthritis treatments, StemExpress offers top quality GMP compliant PBMC and sub cell isolation from a large pool of recallable donors, allowing you to target viable cells that are specific to your research.
Autologous Cell Therapies
Cancer treatments, while life-saving, can greatly impair the body's healthy cell functions. With Autologous stem cell therapies, a patient's healthy stem cells can be collected, frozen and stored prior to intensive radiation or chemotherapy. These stem cells are then returned to the patient post-treatment to replace their damaged cells and promote regrowth and regeneration. At StemExpress, we support the research and advancement of these crucial cellular therapies by providing the source material needed for the early trial and development phases.
If you are researching and developing these vital cellular therapies and you need high-quality starting material for your engineering runs, StemExpress is here to meet your needs.
Our cutting-edge laboratories provide GTP and GMP compliant material samples for the process and development phase - meeting the highest standards from start to finish. For our clients in clinical trials (cellular therapy or otherwise), our experts can isolate specific cells of interest for you, providing you with a specialized, sterile sample. Allow StemExpress to do the work of sourcing and isolating quality, targeted cells, so that you can focus on your projects.
Allogeneic Cell Therapies
Allogeneic stem cell therapies produce promising results for a wide scope of biomedical research studies. Unlike autologous therapies, one healthy donor can provide quality source material for 10,000 other patients! Because these therapies have the potential to affect a considerable amount of people, the FDA has stringent guidelines for the procurement of donor blood and tissue samples. Our GTP tissue collections meet the rigorous FDA 1271 guidelines, ensuring reliable cell collection, isolation, processing and storage. StemExpress also implements extensive donor screening, testing and GTP compliance in an effort to prevent the introduction and transmission of communicable diseases.
For over a decade, StemExpress has led the way in supporting cellular therapies by supplying high quality source material for the process and development phases of research. We offer our clients vast resources, giving access to our 7 distinct donor pools. Our extensive network can provide immeasurable value, ensuring optimal donor selection for cellular material that is tailored to your specific project. At your request, StemExpress will also pre-screen your donors. Once your ideal candidate is selected, we can provide clinical grade Leukopaks from a single donor every 4 weeks.
Looking to do research in Europe? StemExpress offers customized capabilities to meet the requirements of conducting research in other countries. We follow national standards, providing clinical products that follow FDA 1271 testing performed 7 days prior to collection. We also offer EMA, HTA and PMDA compliant testing by adding on additional infectious disease testing at multiple timepoints (pre, during and post). Contact us to discuss your customized protocol needs.
StemExpress follows good tissue practice with rigorous compliance and extensive health screenings. Our Leukopaks are collected from healthy, pre-screened donors using the Spectra Optia® Apheresis System. Our state-of-the-art laboratory headquarters holds two fully enclosed, self-contained BioSpherix devices that operate with a continuously HEPA filtered ISO 5 processing system.
All StemExpress Foundation technicians have been trained in HIPAA, NIH consenting procedures, and hospital and blood-borne pathogen safety. Additionally, our collection process utilizes custom tools and techniques to achieve the largest possible draw volume, making every donation count.
If you have a special request for your clinical grade special documentation needs, let us know!
Partner With Us
Whether you are developing T-cell therapies, studying COVID-19 treatments, or utilizing bone marrow supernatant, StemExpress will work with you to provide the vital cellular material you need. Partner with us for access to our large network of recallable donors, customized protocols, and expert collection processes. We welcome our cellular therapy clients to contact us and schedule an on site audit of our state-of-the-art laboratory facilities