N-glycan is used as a standard for QC analysis of biopharmaceuticals. N-glycan analysis is an important biochemical technology for the research and development of biopharmaceuticals and the comparative research projects of biosimilars and innovative drugs. The technical method can be used to determine the characterization and analysis information of N-glycan sequence information of biopharmaceutical proteins or other biological agents, the connection mode of monosaccharide residues and the number of glycan isomers.
Eukaryotic N-glycan structures (Ladevèze Simon et al. 2016).
Creative Proteomics is a reliable partner with abundant resources in biotechnology related projects. We use systematic operating procedures and provide biopharmaceutical platform solutions to provide you with professional and high-quality biochemical technology analysis services. The characterization and analysis of N-glycans is one of the key parts of ICH Q6B specification. We will provide you with comprehensive and GLP / cGMP compliant N-glycans analysis services around the ICH guidelines (especially ICH Q6B) and the US FDA issues 'Points to Consider' document.
We Can Provide but Not Limited to:
- Quantitative analysis of glycan isomers
- Analysis of the connection of monosaccharide residues
- Structural analysis of N-linked oligosaccharides
- Quality analysis of N-glycan
- Individual glycoform analysis
- Oligosaccharide sequence analysis
Technology Platform of N-glycans Analysis Service:
Creative Proteomics will provide customers with identification and analysis of N-glycan characterization and analysis technologies including N-glycan release technology, fluorescent label detection technology, hydrophilic liquid interaction chromatography (HILIC) separation technology, reversed-phase high-performance liquid chromatography ( RP-HPLC) technology, anion HPLC separation technology, high performance anion exchange chromatography-pulsed amperometric detector (HPAEC-PAD) and Mass Spectrometry (MS) combined technology, etc.
We provide the following analysis methods:
1) PNGase F digestion was used to release N-glycans from the molecule, then solid phase extraction and enrichment of the released N-glycans followed by 2-aminobenzamide (2-AB) labeling. The labeled N-glycans were separated using HILIC chromatography and detected by fluorescence spectroscopy to obtain N-glycan spectra. The specific workflow is as follows.
2) Protein samples were digested with proteases, N-glycans were enriched using RP-HPLC, glycans were separated using anionic HPLC, and HPAEC-PAD and MS were combined to detect and analyze glycopeptide mass spectra to obtain polysaccharide Sugar characterization analysis information. The specific workflow is as follows.
Advantages of N-glycans Analysis Service:
- Short time-consuming: This technical service automatically integrates advanced and systematic biopharmaceutical platform solutions and bioinformatics analysis technologies, which greatly simplifies the experimental operation process and shortens the experimental data analysis time.
- Optimized analysis technology: Software can be used for full-automatic structural analysis to obtain fine structure information of oligosaccharide chain.
- High throughput: This technical service establishes a general method for enriching N-linked oligosaccharides, greatly increasing the coverage of N-glycan detection, and it uses automated experimental equipment to simultaneously detect and analyze multiple experimental samples.
- High sensitivity: Fluorescence Group can enhance the chromatographic and electrophoretic separation capabilities of N-glycans and improve the sensitivity of detection.
- Rapid turnaround time: 5-7 days can provide detailed data collection and processing reports.
- Customized service: We can customize professional solutions for you according to your research plan needs. You can select or suggest the required items for analysis.
Creative Proteomics's research team can provide customers with professional and high-quality N-glycan characterization and analysis services. We will provide you with a comprehensive platform for biopharmaceuticals including fluorescence detection analysis, accurate quality and N-oligosaccharide structure analysis reports and other data collection and processing process related experimental reports. We wholeheartedly provide you with professional and high-quality one-stop service to help you fully confirm and analyze the glycan structure.
References
- Ladevèze Simon, Laville Elisabeth, et al. Mannoside recognition and degradation by bacteria. Biological reviews of the Cambridge Philosophical Society. 2016.
- Higel F, Demelbauer U, et al. Reversed-phase liquid-chromatographic mass spectrometricN-glycan analysis of biopharmaceuticals. Analytical & Bioanalytical Chemistry, 2013, 405(8): 2481-2493.