The U.S. Food and Drug Administration (FDA) began regulating the cord blood banking industry in May 2005 through promulgation of 21 CFR 1271, current Good Tissue Practices. Beyond the federal government, several states (CA, IL, NY, NJ and MD) have applicable state regulations. In addition, several accreditation firms urge cord blood banks to meet their standards of practice.
We are FDA-registered, cGMP-/cGTP-compliant and licensed in all states requiring licensure. We are also AABB-accredited and the first private U.S. cord blood bank to meet the stringent cord blood quality standards set by the Foundation for the Accreditation for Cellular Therapy (FACT), a internationally recognized, independent accrediting organization. In addition, we are ISO 13485:2003-certified by TÜV, an internationally recognized quality assessment organization. Our list of licenses and accreditations make us one of the recognized quality leaders in the field.
FACT's stringent quality standards as used by the top cancer centers
We earned accreditation from FACT by demonstrating compliance with the NETCORD-FACT International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release through an extensive inspection and auditing processes. This includes our advanced collection kit and five-chamber collection bag. This accreditation applies to our cord blood–banking service and our state-of-the-art facility, which were inspected by FACT.
- The 10 top cancer centers in the U.S. are all FACT-accredited.2
- According to a study done at the Memorial Sloan Kettering Cancer Center, stem cell units from a FACT-accredited lab produce better treatment outcomes for patients.1
AABB association's standards for cellular therapies and transfusion medicine
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. AABB accreditation is viewed as one of the most important criteria when choosing or recommending a cord blood bank. By successfully meeting the rigid standards set by the AABB, Cryo-Cell demonstrates its commitment to third party evaluation, total quality management and excellence in our field.
AABB accreditation follows an intensive on-site assessment by specially trained assessors, who evaluate internal policies and procedures and establish that the level of medical, technical and administrative performance within the facility meets or exceeds the standards set by the organization.
ISO 13845 standards for quality management procedures
Technischer Überwachungsverein's (TÜV), or Technical Inspection Association, certification ensures the procedures, methods and controls behind the manufacturing, use and distribution of product meet high standards of quality. This is especially pertinent to the superior cord blood processing method, PrepaCyte-CB®, to which we own the rights and which we make available to other cord blood banks around the globe for the betterment of the entire industry.
Federal good manufacturing requirements (cGMP) and tissue practices (cGTP)
Good Tissue Practice (GTP) is the term used to refer to the FDA regulations for stem cells and tissue. Good Manufacturing Practice (GMP) refers to the FDA regulations for drug products. GTP rules require that systems are in place to prevent the introduction, transmission or spread of communicable disease. GMP rules ensure safe, pure and effective drug products. Although we are not required to meet GMP requirements, it enbles our clients to use their cord blood and cord tissue stem cells for allogeneic purposes and in clinical trials.
Meets all state licensure standards:
Tissue Bank ID# CTB 00080819
Blood Bank ID # 9707
New York State Department of Health
ID# SC 068
Originally Issued: 06/98
New Jersey Department of Health And Senior Services
License # 8585
Originally Issued: 09/99
Maryland Department of Health and Mental Hygiene Office of Health Care Quality
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