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NIST-FDA Workshops on Measurements and Standards for Advanced Therapy


  • Institute for Bioscience & Biotechnology Research (IBBR) Institute for Bioscience & Biotechnology Research (IBBR) 9600 Gudelsky Drive Rockville, MD, 20850 United States (map)

Regenerative medicine, including cell and gene therapy, provides an unprecedented potential to treat or cure previously intractable diseases, such as cancer and rare genetic diseases. Advances in manufacturing technologies, measurements, and standards are needed to ensure the safety, quality, and consistency of this new class of therapies and to reduce cost. NIST in collaboration with FDA has been working with the broader industry and stakeholders to develop global standards underpinned by a robust measurement infrastructure. NIST hosts multiple technical Consortia to jointly develop precompetitive technologies, measurement solutions, and standards to accelerate technology development and translation.

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