Process validation in manufacturing of biopharmaceuticals : guidelines, current practices, and industrial case studies / edited by Anurag S. Rathore and Gail Sofer - 3rd ed. - Boca Raton : CRC Press, 2012 - xvii, 513 p. : ill. ; 24 cm. - Biotechnology and bioprocessing series ; v. 35 . - Biotechnology and bioprocessing series ; v. 35 .

Includes bibliographical references and index

9781439850930 (hbk.)


Pharmaceutical biotechnology--Quality control
Biotechnological process monitoring