Measurement Challenges for CAR-T Biomanufacturing: Highlights from a Meeting Sponsored by the National Institute of Standards and Technology (NIST)

Abstract

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National Cell Manufacturing Consortium http://cellmanufacturingusa.org/road-map

NIST CAR-T Biomanufacturing Symposium https://www.ibbr.umd.edu/NISTCART

Regulatory considerations for manufacturing and testing of investigational chimeric antigen receptor (CAR) T-cell products https://www.ibbr.umd.edu/sites/default/files/public_page/Xiaobin%20Victor%20Lu_FDA.pdf

Simon

Jr. , Lin-Gibson

, Elliott

, Sarkar

, Plant

(2016) Strategies for achieving measurement assurance for cell therapy products. Stem Cells Translational Medicine, 5, 705–708.

NIST Genome Editing Standards Workshop http://www.nist.gov/mml/bbd/genes.cfm

U.S. TAG for ISO/TC276: Biotechnology http://www.nist.gov/mml/bbd/iso.cfm