Quality
Our facility and products adhere to the most stringent quality standards in the world.
Foundation for the Accreditation of Cellular Therapy
FACT Standards are the gold standard in cellular therapy, providing evidence-based guidelines from world-renowned experts. Organizations voluntarily seek this accreditation to demonstrate their foundation of high-quality practices. The standards comprehensively trace the life of a cell product—from donor selection and collection to processing, storage, and patient administration. As a result, physicians and patients actively seek out FACT-accredited organizations for their proven, high-quality cellular products and superior patient care.
Association for the advancement of blood & biotherapies
AABB sets the global quality standard by combining international quality management with crucial technical guidelines. Adopting these standards commits an organization to a complete operational review.
Good Manufacturing Practices
Good Manufacturing Practice (GMP) is key to quality assurance, ensuring medicinal products are consistently made to strict quality standards. All processes and materials must be defined, validated, and documented.1
FDA Registered
We adhere to the U.S. Food and Drug Administration’s (FDA) regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) under 21 CFR Part 1271 following Current Good Tissue Practices (cGTP). This includes mandatory registration, rigorous donor screening, and exacting standards for product safety.
National Marrow Donor Program
The National Marrow Donor Program (NMDP) manages the nation’s primary registry for transplantation. Our cord blood products are listed on the worldwide search registry, accessible for patients in need.