Intact Molecular weight can provide important information about the primary structure and post-translational modifications of a therapeutic protein product. In addition, measurement of intact molecular weight is required by FDA “well characterized biological product” concept and ICH Q6B guidelines.

MALDI-TOF MS and LC-MS are currently two standard methods in measuring the MWt of a protein, with LC-MS as the preferred method due to its higher resolution and accuracy, as well as its ability to resolve the multiple isoforms caused by variation in post-translational modifications (e.g. different glycoforms). We use LC-MS as the default method for intact mass measurement, and report the MWt and ratio of each protein entity detected by an online LC-MS system.

• Protein Mixture Quantitation & Impurity Analysis

• Peptide Mapping

• Disulfide Bond Analysis

• Glycosylation Analysis

• N-terminal and C-terminal Sequencing

• Electrophoresis and Isoelectric Focusing Analysis

• Liquid Chromatographic Analysis

• Colony Selection

• Antibody Epitope Mapping

• Identifying Antibody Molecular Targets

• De Novo Sequencing of mAb

• Software for Characterizing Therapeutic Proteins

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