Washington, D.C. : American Chemical Society ; [New York] : Distributed by Oxford University Press, c1998.
Book — x, 191 p. : ill. ; 24 cm.
The first complete one-volume reference on the topic, this book describes all aspects of process validation in the licensure of recombinant biologics, for both protein and non-protein products. It covers product synthesis, purification, and filling/finishing. (source: Nielsen Book Data)