Beginning with the production of the very first recombinant deoxyribonucleic acid (DNA) molecule in 1972 and continuing through the following decade, DNA-focused molecular biology researchers firmly positioned themselves on the cutting edge of scientific inquiry. With each passing day, month and year, these researchers made significant leaps forward in understanding, modifying and manipulating the key roles that DNA plays in all living organisms. Some of the key milestones…
Category: <span>Nucleic Acids</span>
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…
The Adenovirus Reference Material Working Group (ARMWG) oversaw development of an adenovirus reference material (ARM) with the intent to provide a way to standardize assay measurements from different laboratories. The ARM, which was manufactured in stages by various organizations including Canji (San Diego, CA) and Introgen Therapeutics (Houston, TX), is available from American Type Culture Collection (Manassas, VA). Upon completion of its manufacture, the characterization phase primarily defined viral particle concentration as well as infectious titer for this product. However, many other concurrent characterization studies were conducted including an assessment of vector purity (e.g., host cell DNA, host cell protein, reversed-phase HPLC), a short-term field use and shipping stability study, and a long-term stability study. Also included in these studies was a coordinated effort to determine the complete DNA sequence of the ARM vector genome…