Antibody Glycosylation Analysis Services
Creative Biolabs helps you conquer the complexities of antibody development and streamline your path to market. Our advanced antibody glycosylation analysis services provide the critical insights needed to ensure the quality, safety, and efficacy of your therapeutic products, accelerating drug discovery and optimizing the development of high-quality recombinant proteins.
Glycosylation: A Critical Quality Attribute in Biopharmaceutical Development
Glycosylation, a critical post-translational modification, profoundly influences an antibody's function, stability, and therapeutic efficacy. As the biopharmaceutical industry increasingly relies on monoclonal antibodies (mAbs) for disease treatment, understanding and controlling their glycosylation is paramount. The heterogeneity of glycan structures can alter an antibody's half-life, solubility, and its ability to elicit an immune response, such as antibody-dependent cell-mediated cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC). The development of this analysis is essential to ensure that therapeutic antibodies are both safe and effective. As gene therapy technologies advance to encode for therapeutic protein expression in vivo, robust quality control of the resulting expressed protein—including its glycosylation profile—is a critical next step. This ensures that the gene therapy product translates into a functional, non-toxic, and therapeutically viable protein, underscoring the necessity and significance of this analysis in the broader field of therapeutic development.
Fig.1 The structure of human IgG and glycan composition.1
Antibody Glycosylation Analysis at Creative Biolabs
Confronting the challenges of glycan heterogeneity is paramount for successful therapeutic development. Our antibody glycosylation analysis service is designed to tackle these complexities head-on. By providing precise, reliable data, we empower you to ensure your final product meets the highest standards for quality and regulatory approval. Our approach is grounded in three core principles: Precision, Efficiency, and Quality Assurance. Through a comprehensive, customizable workflow and dedicated scientific support, we deliver the detailed insights needed for confident decision-making, while maintaining a typical turnaround of 4-8 weeks depending on project scope.
Diverse Service Packages
Creative Biolabs offers a tiered approach to antibody glycosylation analysis to meet diverse research and development needs.
This service quantifies the amounts of individual monosaccharides such as fucose, galactose, and mannose. By analyzing the composition of these building blocks, we can screen for compositional changes in your glycosylation profile relative to a reference protein, which provides a fast and effective way to monitor consistency.
Glycan analysis is a powerful tool for monitoring the relative quantities of a specific set of glycans and identifying any aberrant structures. We enzymatically release the N-linked glycans from the protein to ensure accurate structural analysis. These released oligosaccharides are then analyzed using advanced methods such as mass spectrometry (MS) and high-performance liquid chromatography (HPLC) to provide valuable information on your glycan patterns.
Our Glycosylation Site Profiling service goes beyond a general overview to provide a deeper understanding of your antibody. By profiling glycans at the peptide level, we can achieve relative quantification for specific glycosylation sites. This is crucial for understanding how the location of a glycan affects an antibody's function and stability.
Intact Glycoprotein Profiling uses mass spectrometry (MS) to analyze the expected pattern and degree of glycosylation on the complete protein molecule. This method is ideal for assessing the overall glycosylation heterogeneity and provides a holistic view without the need for complex glycan release. The use of ESI-MS allows us to place multiple charges on each species, enabling high-resolution analysis of the full glycoform profile with high sensitivity.
Service Highlights
- High-Resolution Data: Our advanced platforms provide precise, quantifiable data that is critical for ensuring product consistency and safety.
- Accelerated Development: By providing rapid and reliable analysis, we help you make informed decisions quickly, accelerating your path to market.
- Optimized Efficacy: Identifying subtle glycan variations early allows you to optimize cell line selection and bioprocess parameters, maximizing therapeutic efficacy and minimizing the risk of adverse effects.
- Regulatory Compliance: The level of detail and quality of our data is crucial for meeting the stringent regulatory requirements for biopharmaceutical development.
FAQs
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Q1: What is the significance of glycosylation analysis for antibody-based drugs?
A1: Glycosylation is a critical quality attribute (CQA) that impacts an antibody's stability, half-life, and effector functions. Analyzing glycosylation patterns is essential for ensuring your therapeutic antibody is safe and effective for its intended application, and is often a regulatory requirement.
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Q2: What is the main difference between analyzing N-glycans and O-glycans?
A2: The primary difference lies in where the sugar is attached. N-glycans are linked to the nitrogen of an asparagine residue, while O-glycans are attached to the oxygen of a serine or threonine residue. Our services can analyze both, but N-glycan analysis is typically more common for therapeutic antibodies.
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Q3: What types of data will I receive from the analysis?
A3: You will receive a detailed report with a complete glycan profile, including the relative abundance of each glycoform, as well as a list of identified glycan structures. This data provides a clear picture of your antibody's glycosylation status.
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Q4: Do I need to perform a glycosylation analysis for every batch of my antibody?
A4: Glycosylation can be influenced by bioprocess conditions. While a full analysis may not be needed for every single batch, it is highly recommended to perform it for early-stage development, bioprocess optimization, and for all lots intended for clinical trials to ensure consistency and compliance.
Related Sections
To complement your therapeutic antibody project, we offer several other services you might find useful.
- Host Cell Glycoengineering
- Non-Glycosylation or Simplified-Glycosylation
- Optimization of Sialylation
- Optimization of Galactosylation and Degree of Branching
- Fully Human Glycosylation
Work with Creative Biolabs
Creative Biolabs is your expert partner in antibody glycosylation analysis, offering comprehensive solutions that accelerate your drug development pipeline and ensure the quality and safety of your biopharmaceutical products. Our services, backed by advanced technology and deep scientific expertise, provide the critical insights needed to navigate the complexities of glycobiology. For a detailed discussion about your specific needs or to receive a quote, please reach out to us. We look forward to partnering with you on your next breakthrough.
Reference
- Shade, Kai-Ting C., and Robert M. Anthony. "Antibody glycosylation and inflammation." Antibodies 2.3 (2013): 392-414. doi:10.3390/antib2030392. Distributed under an Open Access License CC BY 3.0, without modification.
For Research Use Only.