Public-Private Partnerships to Address Common Cell and Gene Therapy Measurement Challenges

Regenerative medicine, including cell and gene therapy, provides an unprecedented potential to treat or cure previously intractable diseases. Advances in manufacturing technologies and measurements, 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. To collaboratively address common challenges, NIST hosts multiple technical Consortia to jointly develop precompetitive technologies, measurement solutions, and standards to accelerate technology development and translation. Examples of recent efforts and findings will be presented.