Summary
This chapter will review the design and execution of release testing requirements for retroviral vectors and gene-modified cells consistent with ensuring the success of the clinical trial on the basis of current US regulatory requirements. It is the ethical and legal responsibility of the clinical trial sponsor(s) to ensure safety of the patients through proper evaluation of the drug products prior to use. Any clinical trial drug product used in human subjects must be produced and evaluated for safety, quality, purity, and effectiveness according to Current Good Manufacturing Practices appropriate for the stage of clinical development.
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Nordling, D., Kaiser, A., Reeves, L. (2009). Release Testing of Retroviral Vectors and Gene-Modified Cells. In: Baum, C. (eds) Genetic Modification of Hematopoietic Stem Cells. Methods In Molecular Biology™, vol 506. Humana Press. https://doi.org/10.1007/978-1-59745-409-4_18
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DOI: https://doi.org/10.1007/978-1-59745-409-4_18
Publisher Name: Humana Press
Print ISBN: 978-1-58829-980-2
Online ISBN: 978-1-59745-409-4
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