Regenerative medicine and advanced therapies are demonstrating promising clinical efficacy and could change the paradigm for treating a wide range of diseases and injuries. Clinical translation of this broad class of new therapeutics requires better defined and characterized products and more robust, reliable, and cost-effective manufacturing processes.
This program is designed to assist the nascent and promising regenerative medicine industry to meet their measurement assurance and regulatory challenges. NIST contributes to this effort by 1) developing measurement solutions, 2) serving as a neutral ground for the discussion of underpinning measurements and other manufacturing needs, and 3) leading and contributing to the development of standards. Our effort aims to improve the confidence in cell measurements needed for translation and commercialization of advanced therapies, including cell therapy, gene therapy, and tissue engineering