Standards are critical in the development and commercialization of new technologies and facilitate national and international commerce. Standards also have an important role to ensure product consistency and facilitate regulatory approval. NIST is working with key stakeholders to develop Standard Reference Materials and Documentary Standards for regenerative medicine and advanced therapy products, and is leading and contributing to various Standards Development Organizations including ISO/TC 276 and ASTM F04. In addition, NIST administers the US TAG to ISO/TC276 Biotechnology as a means to coordinate national and international standards activities for existing and emerging biotechnology sectors, including regenerative medicine and advanced therapies. In particular, WG3 Analytical Methods is developing standards to enable confident measurements of cells and nucleic acids, and WG4 Bioprocessing is developing a suite of standards aimed to improve the consistency of manufacturing processes for cellular therapeutic products.