Release Testing of Retroviral Vectors and Gene-Modified Cells
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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A Cleanup Method for Mass Spectrometry of Sphingosine-1-Phosphate in Blood and Solid Tissues Using a
Cleanup technology and mass spectrometric determination of s...
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Fluorescence In Situ Hybridization on Single Cells: Sex Determination and Chromosome Rearrangements
Fluorescence in situ hybridization (FISH) is the technique o...