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J Pharm Sci. 2013 Mar;102(3):1125-32. doi: 10.1002/jps.23428. Epub 2012 Dec 20.

Immunoglobulins M survive low-pH conditions used for virus inactivation and for elution from bioaffinity columns.

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  • 1Bioprocessing Technology Institute (BTI), Agency for Science, Technology and Research (A*STAR), Centros, Singapore 138668, Singapore. monika_mueller@bti.a-star.edu.sg

Abstract

Tolerance of low pH is crucial for recombinant proteins to survive conditions that might be experienced during manufacturing such as virus inactivation and elution from bioaffinity columns. In this study, we exposed three different purified immunoglobulins M (IgMs) to pH 3.5 for 60 min at room temperature. Treated samples showed no significant aggregation or fragmentation and retained full immunoreactivity, an intact glycosylation profile, and unchanged thermal stability. Because IgMs are serious candidates for next-generation therapeutics, it is essential to know that some of them are stable at low pH.

Copyright © 2012 Wiley Periodicals, Inc.

PMID:
23280704
[PubMed - indexed for MEDLINE]
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