Industry experience is insufficient at present to identify a standard platform for IgM purification, but the tools available
to process developers provide an abundance of effective options. Either hydroxyapatite or cation exchange may support effective
capture, depending on the properties of a particular IgM. The high capacity and resolution of monolithic ion exchangers at
high volumetric flow rates—despite the large size of IgM—make them a compelling process option at any point in a purification
process. All methods discussed in this study are potential candidates for aggregate removal, and their capabilities can be
enhanced, if necessary, by the presence of PEG. Together, these tools provide a level of purification, recovery, and throughput
that rival the best commercial IgG purification procedures. Far from being a liability, the lack of an affinity step makes
a positive contribution to overall process economy.
PETE GAGNON is the chief scientific officer of Validated Biosystems, San Clemente, CA,
FRANK HENSEL is the managing director of Patrys GmbH, Würzburg, Germany, and RICHARD RICHIERI is the vice president of manufacturing and research and development at Avid Bioservices, Inc., Tustin, CA.
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