By T.R. Flotte, and K.I. Berns (Eds.)
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Extra info for Adeno-Associated Viral Vectors for Gene Therapy
Total and infectious particle titers need to be determined to evaluate dosing and the total particle:infectious particle ratio. , 1998). Finally, several other quality criteria have been established for the clinical use of gene transfer vectors (CBER, 1998). 10. Clinical manufacturing regulatory compliance activities As the suitability of the vector for clinical trial use becomes apparent during research and pre‐clinical safety evaluations, manufacturing controls and quality systems should be developed.
Other safety studies may be required. , or studies to determine the vector’s physical or chemical characteristics do not need to be performed in a manner compliant with GLP regulations. GLP compliance ensures the quality and acceptability of the safety data generated in these studies. Characterization of the vector batch used in non‐clinical safety studies is also performed in compliance with GLPs. Care should be taken to ensure that adequate and appropriate processes are used to produce the batch(es) required, and the production process should be similar to that proposed for production of the vector for human clinical trials, or at least performed in such a way that adequate documentation of the production methods is available for comparative purposes.
2003), assays are available to monitor their presence. The first is the standard plaque assay on 293 cells for Ad or on Vero cells for HSV. The second is a TCID50 assay where cytopathic eVect (CPE) is scored after serial dilution of the rAAV vector and infection of suitable complementing cells. 7. Assay for transgene expression The assay for transgene expression involves the transduction of tissue culture cells or animals, and testing for the presence of the transgene protein product. Reagents (antibodies, enzymatic substrates, nucleic acid probes) specific for the transgene product should be made in large quantities, so the assay can be repeated several times.