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THE WBF BOOK SERIES--ISA 88 and ISA 95 in the Life Science Industries by The WBF

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CHAPTER 18

Multiple Products in a Monoclonal Antibody ISA-88.01 Batch Plant
Presented at the WBF North American Conference, May 16–19, 2004, by
Mahasti KheradmandAutomation Supervisormkheradm@gene.comGenentech, 1000 New HorizonsWay, Vacaville, CA 95688 USA
John O’ConnellAutomation Supervisorjohno@gene.comGenentech, 1000 New HorizonsWay, Vacaville, CA 95688 USA

Abstract

The most successful biotech companies have multiple products approved for market and must make use of existing manufacturing capacity to produce them. Oftentimes, this requires rapid changeover from one product to the next. This chapter addresses the challenges of bringing new products into an existing ISA-88.01 facility and the challenges involved with implementing ...

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