Purification of IgM Monoclonal Antibodies - Manufacturing challenges surround the use of IgM monoclonal - BioPharm International

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Purification of IgM Monoclonal Antibodies
Manufacturing challenges surround the use of IgM monoclonal


BioPharm International Supplements


CONCLUSION

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, http://www.validated.com/, 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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