GMPs-Grade Retroviral Vector Manufacturing: Process and Facility Design

by Cecilia Sendresen, PhD
Volume 3, Issue 5 (September/October 2004)

The Good Manufacturing Practices (GMPs) are becoming more and more familiar in biotechnology, and concepts such as quality assurance or validation are now part of the background of clinicians and researchers involved in clinical trials. A recent European Community directive (2001/20/CE) states that GMPs should also be applied to investigational medicinal products and not only to products on the market. Vector supernatant is a so-called Active Pharmaceutical Ingredient (API) and is subject to the same guidelines as traditional drugs produced by the pharmaceutical industry. This has a deep impact in the field of gene therapy because clinical trials are often run by small biotech companies or, at least in the first phases, by academic centers. The field is continuously developing and, according to the progress of the clinical studies, new processes are necessary to produce large-scale amounts of vector supernatant in a safe and reproducible way…

Sendresen C. GMPs-Grade Retroviral Vector Manufacturing: Process and Facility Design. BioProcess J, 2004; 3(5): 37-39.