Case Study

Automated Software-Driven MAM Implementation for Biotherapeutic Characterization

Automated Software-Driven MAM Implementation for Biotherapeutic Characterization

Pages 4 Pages

Automated Software-Driven MAM Implementation for Biotherapeutic Characterization Background Conventional biopharmaceutical characterization and quality-control methods are based on determination of physical attributes through classic biophysical analysis technologies that rely on indirect measurement of the molecules contained in the sample. Because biologics are heterogeneous mixtures of complex molecules, more advanced techniques that provide direct measurements of the attributes are desired. Recently, an alternative approach based on liquid chromatography-mass spectrometry (LC-MS) has been developed [1,2] . Termed the multi-attribute method (MAM), this approach uses the content-rich data provided by mass spectrometric analyses to characterize biopharmaceuticals at the molecul

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