Processing

Upon arrival to our new Las Vegas processing laboratory the cord blood is immediately processed. Laboratory processing is performed utilizing 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. We process to standards that exceed today's FDA cord blood requirements by processing in compliance with current Good Manufacturing Practice standards (cGMP).

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.

This means that the cord blood processed by CorCell will not only be eligible for straightforward transplants in the future but will also qualify for manufactured therapies in the future 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.

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. Plus, a count is taken of the number of stem cells in the specimen. We then provide a report to the parents of the results.