Immunoglobulins M Survive Low-pH Conditions Used for Virus Inactivation and for Elution from Bioaffinity Columns

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. © 2012 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:1125-1132, 2013