Regenerative medicine | NIST
February 10th, 2024 2:33 amRegenerative medicine therapy, including cell therapy, gene therapy, and therapeutic tissue engineering, provides unprecedented potential to treat, modify, reverse, or cure previously intractable diseases, such as cancer and organ failures. This class of therapy has completely changed the paradigm and the trajectory for medical treatment. Broad clinical translation and patient access requires advances in manufacturing technologies and measurements to ensure the safety, quality, and consistency of the therapy and to reduce the cost.
NIST is committed to solving the measurement challenges of this fast-moving sector of the bioeconomy by providing underpinning measurement infrastructure and platform technologies, as well as standards to promote manufacturing innovation, improve supply chain resilience, and support characterization and testing to facilitate regulatory approval.
The NIST Regenerative Medicine program is working closely with the U.S. Food and Drug Administration'sCenter for Biologics Evaluation and Research(FDA/CBER) and the Standards Coordinating Body (SCB) as well as the broader industry to develop global manufacturing and measurement standards underpinned by a robust measurement infrastructure needed to advance product development and translation as directed by Sec. 3036 of the 21st Century Cures Act.
The NIST laboratory programs support this growing industry as well as the broader industry ecosystem by:
NIST has developed a suite of standards and tools for characterizing biological systems and components using advanced measurement science strategies that enable the generation of high-quality data. Some recent examples of NISTs work include:
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Regenerative medicine | NIST