In according to the FDA “well characterized biological product” concept and ICH Q6B guidelines, we provide following liquid chromatographic analysis services for the characterization and confirmation of therapeutic proteins:

Reverse Phase Chromatography: a reverse phase chromatography (often based on a optical detector) of test protein and a reference standard will be reported, which can provide important information about the comparability between the test sample and the reference standard.

Ion Exchange Chromatography: an ion exchange chromatography (often based on a optical detector) of test protein and a reference standard will be reported, which can provide important information about the charge heterogeneity of the protein product and the comparability between the test sample and the reference standard.

Size Exclusion Chromatography: a size exclusion chromatography (with optical detector) of test protein and a reference standard will be analyzed and reported, which can provide important information about the possible aggregation of the protein and the comparability between the test sample and the reference standard.

• Protein Mixture Quantitation & Impurity Analysis

• Peptide Mapping

• Disulfide Bond Analysis

• Glycosylation Analysis

• Intact Molecular Weight Measurement

• N-terminal and C-terminal Sequencing

• Electrophoresis and Isoelectric Focusing Analysis

• Colony Selection

• Antibody Epitope Mapping

• Identifying Antibody Molecular Targets

• De Novo Sequencing of mAb

• Software for Characterizing Therapeutic Proteins

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