Protein Drug Glycosylation Analysis Service

Protein drugs have become the core products in modern biopharmaceuticals, including monoclonal antibodies, recombinant proteins, fusion proteins, and others. As one of the key post-translational modifications influencing drug structure and function, glycosylation plays a vital role in determining the stability, half-life, solubility, immunogenicity, and pharmacological properties of protein drugs. Different glycan types and distributions may directly affect antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and drug metabolism pathways in vivo. Therefore, systematic and accurate glycosylation analysis is essential for drug development, quality control, and consistency evaluation.

 

Rocamora, F. et al. Biotechnol Adv. 2023.

as a professional proteomics CRO company, MtoZ Biolabs provides high-quality protein drug glycosylation analysis service by leveraging advanced mass spectrometry platforms, mature chromatographic separation systems, and optimized analytical strategies. We are committed to assisting academic and pharmaceutical clients in deeply characterizing protein drug glycosylation features, offering reliable data support for drug design, development, and clinical application.

 

Services at MtoZ Biolabs

At MtoZ Biolabs, our protein drug glycosylation analysis service covers glycosylation site identification, glycan structure analysis, glycan quantification, glycan microheterogeneity evaluation, and functional relevance analysis. By combining liquid chromatography and high-resolution mass spectrometry, we are able to comprehensively characterize the glycosylation profiles of protein drugs and provide a complete dataset from qualitative to quantitative. Our service includes:

1. Glycosylation site identification: Accurately determine the amino acid residues where glycosylation occurs (such as N-linked sites) to ensure precise understanding of modification positions.

2. Glycan structure analysis: Analyze monosaccharide composition, branching patterns, linkage types, and terminal modifications of glycans.

3. Qualitative and quantitative analysis: Compare glycan profiles across different batches, process conditions, or clinical stages of protein drugs.

4. Microheterogeneity analysis: Reveal glycoform diversity within the same protein, providing a basis for drug consistency and stability evaluation.

5. Functional relevance analysis: Assess the potential impact of glycosylation on pharmacokinetics, immune response, and stability of protein drugs.

 

Main Analytical Techniques

1. Mass Spectrometry (MS)

Protein drug glycosylation analysis service relies on mass spectrometry as the core technique, enabling both glycosylation site identification and glycan structure elucidation. Through LC-MS/MS and high-resolution mass spectrometry platforms (such as Orbitrap and Q-Exactive), glycosylation sites can be precisely identified, and glycan composition, branching, and modifications can be resolved. With different fragmentation modes (such as HCD, ETD, and EThcD), MS can distinguish complex glycan linkages and detect low-abundance modifications, providing highly reliable qualitative and quantitative data.

 

2. Capillary Electrophoresis (CE)

Capillary electrophoresis, with its high resolution and fast separation capacity, serves as an important complementary method for glycan structural analysis. This technique effectively distinguishes different isomers and charge variants of glycans, making it especially suitable for evaluating glycan microheterogeneity and charge distribution. Combined with fluorescent labeling detection, CE offers high sensitivity and reproducibility in quantitative analysis, providing a powerful tool for batch-to-batch or process-related glycosylation consistency assessment.

 

3. Glycan Microarray

Glycan microarray is a high-throughput chip-based platform that systematically detects interactions between proteins and various glycans. In protein drug glycosylation analysis, it is often used to evaluate the functional relevance of glycan structures, such as their binding to receptors, antibodies, or immune molecules. Integrated with MS and CE data, glycan microarray provides functional interpretation, revealing the impact of glycosylation on drug stability, immunogenicity, and therapeutic efficacy.

 

Analysis Workflow

Illiano, A. et al. Cells. 2020.

Figure 2. Workflow for MS-based protein glycosylation analysis

  

Service Advantages

1. Comprehensive glycosylation analysis

Our protein drug glycosylation analysis service characterizes protein drug glycosylation from site, structure, quantitative, and functional perspectives, meeting the needs of basic research, drug development, and quality control.

 

2. High resolution and sensitivity

By utilizing high-resolution MS platforms such as Orbitrap and Q-Exactive, combined with optimized chromatographic separation methods, we ensure accurate elucidation of complex glycan structures and reliable detection of low-abundance modifications.

 

3. Flexible and customized services

Based on different research goals, we provide highly customized analytical solutions. Whether for rapid quality assessment or comprehensive glycosylation profiling, clients receive tailored technical support and deliverables.

 

4. One-Time Charge

Our pricing is transparent, with no hidden fees or additional costs.

 

Applications

1. Biopharmaceutical development and quality control: Monitor glycosylation characteristics to ensure drug consistency and safety.

2. Pharmacodynamics and pharmacokinetics research: Evaluate the impact of glycosylation on drug stability, half-life, and immunogenicity.

3. Disease mechanism studies: Explore the relationship between abnormal glycosylation patterns and diseases.

4. Biomarker discovery: Identify potential diagnostic and prognostic markers based on glycosylation features.

 

FAQs

Q1: Can your analysis services distinguish different types of glycans?

A1: Yes. Our MS and chromatography platforms can distinguish high-mannose, hybrid, and complex glycans, and resolve their branching and terminal modifications.

 

Q2: How long does the protein drug glycosylation analysis service usually take?

A2: The typical analysis cycle is about 2–4 weeks, depending on project complexity and required depth.

 

Sample Submission Suggestions

1. Sample type: Applicable to monoclonal antibodies, recombinant proteins, fusion proteins, and other protein drugs.

2. Sample amount: Sufficient material is required to ensure reliable glycosylation detection; please contact us in advance to confirm based on research objectives.

3. Sample transportation: Dry ice shipment is recommended to avoid long-term exposure at room temperature.

4. Sample storage: Store at –80°C, avoid repeated freeze-thaw cycles to maintain glycosylation integrity.

 

Deliverables

1. Sample pretreatment and experimental records

2. Glycosylation site identification results

3. Glycan structure analysis report

4. Qualitative and quantitative analysis data

5. Raw MS files

6. Data visualization

7. Comprehensive analysis and functional annotation report

 

The glycosylation characteristics of protein drugs not only determine their efficacy and safety but also represent a critical parameter in drug development and quality control. MtoZ Biolabs, leveraging advanced MS platforms and systematic analytical solutions, provides high-quality and reproducible protein drug glycosylation analysis service. We look forward to collaborating with you to advance scientific research and clinical applications of biopharmaceuticals.

Contact us today to start your glycosylation analysis project.