Vaccine Scale-Up and Manufacturing
Donald F. Gerson, Bhawani Mukherjee and Rattan Banerjee
from: AIDS Vaccine Development: Challenges and Opportunities (Edited by: Wayne Koff, Patricia Kahn and Ian D. Gust). Caister Academic Press, U.K. (2007)
Abstract
It is not true that if you make a small machine that works, and then make a larger one in exactly the same way with the same materials, that it will also work. (Feynman, 1994). In vaccine development, the laboratory process for producing a test antigen during the discovery phase cannot be used to make vaccines at large manufacturing scale. Rather, detailed experimentation is needed to ensure that the product can be made reproducibly-not 3 times but 3 billion times over a span of many years. Vaccine manufacture and licensure are facility, equipment and process-dependent; in other words, the process defines the product. Creating a robust, reproducible manufacturing process is therefore key to licensure and to ensuring a long-term supply of high-quality vaccine. This article describes the complexities of scaling up vaccine production from the laboratory to the factory, reviews the technologies needed to manufacture different categories of AIDS vaccine candidates, and discusses various models for financing manufacture in ways that promote vaccine access in the world's poorest regions read more ...
