Standard developing organizations & other organizations developing standards
AABB is the global leader in standards development, accreditation and implementation of quality systems in transfusion medicine and cellular therapies. AABB Standards combine internationally accepted quality management system requirements with relevant technical requirements for each discipline. As such, the Standards can serve as the basis for accreditation anywhere in the world.
ARMI - Advanced Regenerative Manufacturing Institute (http://www.armiusa.org)
ARMI will make practical the large-scale manufacturing of engineered tissues and tissue-related technologies, to benefit existing industries and grow new ones. To carry out its mission, the ARMI will integrate innovative cell and tissue cultures with advances in biofabrication, automation, robotics, and analytical technologies to create disruptive research and development tools and FDA-compliant volume manufacturing processes.
ASGCT - American Society of Gene & Cell Therapy (http://www.asgct.org)
The American Society of Gene & Cell Therapy is the primary professional membership organization for gene and cell therapy. The Society's members are scientists, physicians, patient advocates, and other professionals. Our members work in a wide range of settings including universities, hospitals, government agencies, foundations, biotechnology and pharmaceutical companies.
ASTM International (https://www.astm.org)
ASTM International is a globally recognized leader in the development and delivery of voluntary consensus standards. Today, over 12,000 ASTM standards are used around the world to improve product quality, enhance health and safety, strengthen market access and trade, and build consumer confidence.
- ASTM F04 - Medical and Surgical Materials and Devices
FACT - Foundation for the Accreditation of Cellular Therapy (http://www.factwebsite.org)
FACT establishes standards for high quality medical and laboratory practice in cellular therapies. FACT is a non-profit corporation co-founded by the International Society for Cellular Therapy (ISCT) and the American Society of Blood and Marrow Transplantation (ASBMT) for the purposes of voluntary inspection and accreditation in the field of cellular therapy.
FDA - U.S. Food and Drug Administration (https://www.fda.gov)
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
HESI - ILSI Health and Environmental Sciences Institute (http://hesiglobal.org)
The Health and Environmental Sciences Institute (HESI) is a non-profit institution whose mission is to collaboratively identify and help to resolve global health and environment challenges through the engagement of scientists from academia, government, industry, NGOs, and other strategic partners
ISCT - International Society for Cellular Therapy (http://www.celltherapysociety.org)
ISCT is a global society of clinicians, regulators, technologists, and industry partners with a shared vision to translate cellular therapy into safe and effective therapies to improve patients' lives. ISCT consists of an influential global community of peers, experts, and organizations invested in cell therapy. ISCT offers a collaboration between academia, regulatory bodies, and industry partners in cell therapy translation.
ISO - International Organization for Standardization (https://www.iso.org)
ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.
The International Society for Stem Cell Research (ISSCR) is an independent, nonprofit organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application.
NIIMBL - The National Institute for Innovation in Manufacturing Biopharmaceuticals (http://www.niimbl.us)
NIIMBL is a public-private consortium dedicated to accelerating biopharmaceutical manufacturing innovation, supporting the development of standards that enable more efficient and rapid manufacturing capabilities, and educating and training a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry.
NIST - National Institute of Standards and Technology (https://www.nist.gov)
The National Institute of Standards and Technology (NIST) is now part of the U.S. Department of Commerce. NIST is one of the nation's oldest physical science laboratories. NIST measurements support the smallest of technologies to the largest and most complex of human-made creations—from nanoscale devices so tiny that tens of thousands can fit on the end of a single human hair up to earthquake-resistant skyscrapers and global communication networks.
USP - U.S. Pharmacopeial Convention (http://www.usp.org)
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
- Chapter 1046 – Cell and Gene Therapies Products
- Chapter 1047 – Gene Therapy Products
- Chapter 1043 – Ancillary Materials for Cell, Gene and Tissue-Engineered Products
- Chapter 92 – Growth Factors and Cytokines Used in Cell Therapy Manufacturing
- Chapter 90 – Fetal Bovine Serum—Quality Attributes and Functionality Tests