The Processing Lab
- Processing is performed at our new Las Vegas Laboratory. Testing is conducted by CLIA approved, licensed reference laboratories.
- All specimens are tested to ensure the stem cells meet the rigid standards for transplantation or other therapeutic use. They are evaluated for bacterial contamination and infectious disease. Also, the number of stem cells and CD34 cells are counted both before and after processing.
- This means that the cord blood processed by CorCell will not only be eligible for straightforward transplants but will also qualify for future manufactured therapies where the stored cord blood stem cells are but a single ingredient.
- Therefore, the benefit is that the potential use of the stem cells is not limited to simple transplantation but remains open to future cell therapies to come from today's research using cells stored today with tomorrow in mind. This is a unique advantage CorCell offers our customers.
- CorCell uses the BioE PrepaCyte-CB® sterile cord blood processing system. The BioE system is
510K and FDA approved - The BioE system is manufactured under FDA Current Good Manufacturing Practice (cGMP) regulations. The interconnected three-bag design, along with the sterile fluid path, limits cell manipulation and helps minimize environmental contamination and identification errors
- CorCell manually process cord blood, which allows flexibility not available with automated systems. Our technicians have control at each stage of the process. Automated systems assume every cord blood sample is exactly the same, when in fact each sample is unique to their donors. The BioE system is flexible: our technicians have control at each stage of sample processing
CorCell has installed a validated tracking software, StemLab™ software, which supports the collection, processing, storage and distribution or administration of high-quality cellular therapy products. StemLab™ is specifically developed for cord blood banks. StemLab™ is built to ensure quality and regulatory compliance standards are met by establishing procedural protocols, monitoring manufacturing processes, and documenting lot to lot traceability.
We ensure that your newborn's cord blood is handled by only experienced lab technicians. All lab technicians have multiple years of experience processing cord blood.
