We offer a service of Glycosylation Analysis, which is a key part of FDA “well characterized biological product concept” and ICH Q6B guidelines, and is important to establish the comparability of a protein product to its reference standard or between different batch releases.

The glycosylation sites of a therapeutic protein product are analyzed and reported by our Peptide Mapping service. The MS/MS data of glycopeptides are used to confirm the carbohydrate structures of glycosylation forms. All the common forms of N-glycosylation in therapeutic antibodies produced by CHO cells (including G0F, G1F, G2F, G3F, G4F and G5F) can be routinely identified by our Peptide Mapping service. We can also search any glycosylation forms that are specified by a customer.

We also provide a service for oligosacchride profiling. In this service, the N-glycan is first released by peptide N-glycosidase (PNGase), and then derivatized by a reaction with 2-aminopyridine. A normal phase HPLC with a fluorescence detector is used to profile all N-glycan forms. The HPLC fractions are collected and analyzed off-line by MS/MS to confirm the assignment of glycan forms.

• Protein Mixture Quantitation & Impurity Analysis

• Peptide Mapping

• Disulfide Bond Analysis

• Intact Molecular Weight Measurement

• 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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