The Role of the National Institute of Standards in Measurement Assurance for Cell Therapies

Author:

Plant Anne L.,Camp Charles,Elliott John T.,Eskandari Tara,Halter Michael,Kwee Edward,Maragh Samantha,Peterson Alexander,Pierce Laura,Sarkar Sumona,Simon Carl,Wang Lili,Zook Justin,Lin-Gibson Sheng

Publisher

Springer International Publishing

Reference50 articles.

1. National Cell Manufacturing Consortium. (2017). Achieving large-scale, cost-effective, reproducible manufacturing of high-quality cells [Online]. Available: http://cellmanufacturingusa.org/ncmc. Accessed 17 July 2020.

2. Alliance for Regenerative Medicine. https://alliancerm.org/manufacturing/. Accessed 17 July 2020.

3. U.S. CONGRESS. (2016). 21st Century Cures Act H.R.34. Washington DC. Federal Register. https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification. Accessed 17 July 2020.

4. U.S. Food and Drug Administration. (2019). Standards development and the use of standards in regulatory submissions reviewed in the center for biologics evaluation and research. Guidance for industry. March 2019. https://www.fda.gov/media/124694/download. Accessed 17 July 2020.

5. Rosslein, M., Elliott, J. T., Salit, M., Petersen, E., et al. (2015). Use of cause-and-effect analysis to design a high-quality nanocytotoxicology assay. Chemical Research in Toxicology, 28, 21–30.

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