Experience Matters

Having worked with thousands of allogeneic donors over the past 30 years, Gift of Life Marrow Registry’s Quality Systems and Compliance team has developed deep expertise to ensure compliance across multiple accrediting bodies and regulatory agencies.

  • Accredited by the World Marrow Donor Association as a hematopoietic progenitor cell registry
  • Accredited by the Association for the Advancement of Blood and Biotherapies (AABB) as a hematopoietic progenitor cell collection facility
  • CLIA accredited for the performance of non-waived (moderate and/or high complexity) testing
  • Recipient of AABB Cellular Starting Material (CSM) Qualification recognizing quality systems meeting AABB evidence-based standards for the collection, storage and/or processing of cellular starting materials.
  • Licensed by the State of New York State as a comprehensive tissue procurement service and tissue processing facility
  • Licensed by the State of Florida as A Restricted Drug Distributor-Blood Establishment
  • Registered with the Food and Drug Administration as an HCT/P establishment
CMO Qualified Supplier
  • Contract manufacturer for Be The Match BioTherapies for HPC-A and MNC-A
  • Approved apheresis center for the National Marrow Donor Program

Quality Management System

Gift of Life’s Quality Management System covers all aspects of operations, including quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling. Elements include training and competencies, deviations and complaints, document control, change management, good documentation practices, supplier and service provider qualification, supply management, adverse events, risk management, non-confirming products and equipment management. Gift of Life adheres to current good tissue practices and good manufacturing practices.