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Characterization of Recombinant Protein Biotherapeutics by UHPLC-SEC-MALS

INTRODUCTION

Biotherapeutics are generally larger molecules such as peptides, proteins and monoclonal antibodies with monomer molecular weight ranging from 3,000-150,000 Da. The drug must remain free from impurities such as fragment, dimer and other higher order aggregates as they may cause severe immunogenic response. This becomes even more important if the biotherapeutic protein is thermally susceptible. Historically, size exclusion is the preferred mode of chromatography used for separation and characterization of such applications. Here we report the online detection of absolute molecular weight of two recombinant protein samples using a UHPLC size exclusion chromatography (SEC) column directly connected to the LenS3TM Multi-Angle Light Scattering (MALS) detector.

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