Identifying and Managing Sources of Variability in Cell Therapy Manufacturing and Clinical Trials

Author:

Silverman Lara IonescuORCID,Flanagan Flagg,Rodriguez-Granrose Daniel,Simpson Katie,Saxon Lindsey Hart,Foley Kevin T.

Funder

National Science Foundation

DiscGenics

Publisher

Springer Science and Business Media LLC

Subject

Cell Biology,Biomedical Engineering,Biomaterials,Medicine (miscellaneous)

Reference10 articles.

1. FDA. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products . Accessed July 24, 2019.

2. Q1 2019 Data report Alliance for regenerative medicine. 2019. https://alliancerm.org/publication/q1-2019-data-report/ . Accessed July 17 2019.

3. Dagenais S, Tricco AC, Haldeman S. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. Spine J. 2010;10(6):514–29.

4. Guidance for industry: current good tissue practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). US Department of Health and Human Services Food and drug Administration Center for Biologics Evaluation and Research Center for devices and radiological health Office of Combination Products. December 2011; https://www.fda.gov/media/82724/download . Accessed 17 July 2019.

5. Regulatory considerations for human cells, tissues, and cellular and tissue- based products: minimal manipulation and homologous use, Guidance for industry and Food and Drug Administration staff. US Department of Health and Human Services Food and drug Administration Center for Biologics Evaluation and Research Center for devices and radiological health Office of Combination Products. December 2017; https://www.fda.gov/media/109176/download . Accessed 17 July 2019.

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