One resin, multiple products: A green approach to purification

Ekta Mahajan, Jay Werber, Kapil Kothary, Tina Larson

Research output: Chapter in Book/Report/Conference proceedingChapter

4 Scopus citations

Abstract

Protein A affinity chromatography is a key purification step used during the purification of recombinant monoclonal antibodies (mAbs) harvested from cell culture fluid (HCCF). During this purification process typically a single Protein A resin is dedicated to purify a specific mAb of interest. For clinical manufacturing and pilot plant runs this can result in significant resin underuse, such that the Protein A resin is only used 10% of its potential lifetime. Herein we demonstrate that significant cost savings can be achieved (annually) if the Protein A resin is reused for multiple products. In this study, a cleaning procedure called the MabSelect SuRe™ Campaign Changeover Procedure (MSSCCP) was developed on lab-scale to reduce protein carryover during the reuse of the Protein A resin for purification of multiple products. Use of the MSSCCP cleaning procedure results in less than 1 ppm carryover of intact IgG into subsequent purification samples. This low protein carryover is 103 fold less protein carryover than that set in safety margins, and demonstrates that the same Protein A resins can be used to purify multiple products. The reuse procedure was successfully implemented on lab scale, and on pilot plant scale for the production of mAb drug substances.

Original languageEnglish (US)
Title of host publicationDevelopments in Biotechnology and Bioprocessing
PublisherAmerican Chemical Society
Pages87-111
Number of pages25
ISBN (Print)9780841229105
DOIs
StatePublished - Mar 8 2013

Publication series

NameACS Symposium Series
Volume1125
ISSN (Print)0097-6156
ISSN (Electronic)1947-5918

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