by Kenneth R. Paynter, Hui Hou, and Fei Lu, MD
Volume 3, Issue 5 (September/October 2004)
Currently, the U.S. Food and Drug Administration (FDA) recommends DNA sequencing for the structural characterization of gene transfer viral vectors in investigational New Drug Applications (INDs). While FDA provides guidelines on what should be sequenced in regard to these vectors, it provides little insight — beyond GLP/GMP (GxP) guidelines — into how the finalized sequence data should be obtained. There is presently no provision for determining which sequencing methodology (or methodologies) is most appropriate for obtaining a completed sequence characterization for each of the different vector classes, and there is no standard that outlines what DNA sequencing-specific criteria the data and data collection processes should meet in order to guarantee that the sequence is 99.99% accurate…
Citation:
Paynter KR, Hou H, Lu F. Nucleic Acid Analysis of Viral Vectors: A Contract Research Organization’s Perspective. BioProcess J, 2004; 3(5): 47-51.