June 11, 2014
Did you know that cord blood banking is regulated by the FDA? When it comes to cord blood banking, CariCord has the quality you can trust. CariCord’s laboratory and storage facilities are located at the University of Colorado’s Anschutz Medical Campus, part of the Colorado Science and Technology Park. It is a highly credentialed facility with a long history of life-saving research in current and next-generation technology. Parents, you can rest assured knowing that your baby’s cord blood is in the hands of not only a highly trained and experienced staff, but that it will be processed and stored in a state-of-the-art, licensed facility.
Private cord blood banks are required to register their address, listing, screening and testing for infectious diseases, and reporting and labeling requirements with the FDA, however, privately stored cord blood use in the donor or a family member does not require prior FDA approval. CariCord’s laboratory takes that a step further though.
CariCord’s lab is one of only five facilities in the world that is approved by the FDA to manufacture cord blood as a pharmaceutical drug. CariCord is the only private family bank processing cord blood units in a laboratory that is FDA licensed to manufacture cord blood. The lab is equipped with a Class 10,000, or ISO 7, controlled clean room, which is an environment free of dust, microbes, chemical vapors and other contaminants.
The stem cell laboratory is endorsed by the Foundation for Accreditation of Cellular Therapy (FACT). It is also CAP (College of American Pathologists) accredited. It has been processing cord blood units under federal contract since 2006 and was among the first to raise its umbilical cord blood banking practices to FDA BLA (Biologics License Application) licensing.
The cord blood bank is also AABB (American Association of Blood Banks) accredited. To become AABB accredited, the laboratory must be assessed for quality and operational systems in place within the facility, all in an effort to improve the quality and safety of collecting, processing, testing, distributing and administering blood and blood products, according to the AABB.
Why is all of this important? Because the stem cells in cord blood are being used as medicine. We are fairly certain that if the need for this medicine ever arises, parents want the very best medicine available. When it comes to choosing a cord blood bank to store your baby’s umbilical cord blood stem cells, QUALITY counts and CariCord has a proven track record and accreditations to stand on.