by Scott Jendrek, Denise Ekstrom, PhD, Daniel Stoughton, PhD, Sawako Ishikawa, Dexter Poon, PhD, Wei Cheng, Steve Giardina, PhD, and David Mallard
Volume 5, Issue 1 (Spring 2006)
The number of viral vectors designed for gene therapy applications in the cGMP pipeline is staggering. Similar in scope to the flurry of recombinant protein products of the 1980s and the monoclonal antibodies (MAbs) of the 1990s, viral vector-based products are surging from research labs and universities into contract manufacturing organizations (CMOs), ultimately destined for use in clinical trials. Unlike recombinant proteins and MAbs, both of which sometimes require grams of vialed final product to start Phase I studies, the amount of material required to move a viral vector-based product into clinical trials can be minute in comparison. Of all the viral vectors currently in clinical trials, more than 25% are based on adenovirus…
Citation:
Jendrek S, Ekstrom D, Stoughton D, Ishikawa S, Poon D, Cheng W, Giardina S, Mallard D. Development of a Production and Purification Method for Type 5 Adenovirus. BioProcess J, 2006; 5(1): 37-42. https://doi.org/10.12665/J51.Jendrek