An Automated MS Data Workflow Enabling Targeted, Site-Specific N-Glycosylation Monitoring of Biopharmaceuticals
公司规模
Large Corporate
地区
- America
国家
- United States
产品
- Genedata Expressionist
技术栈
- LC-MS glycopeptide mapping method
- 2-AB UHPLC method
实施规模
- Enterprise-wide Deployment
影响指标
- Productivity Improvements
- Innovation Output
技术
- 分析与建模 - 大数据分析
- 分析与建模 - 实时分析
适用行业
- 药品
适用功能
- 产品研发
- 质量保证
用例
- 质量预测分析
- 根因分析与诊断
服务
- 数据科学服务
关于客户
The customer in this case study is a biopharmaceutical developer, likely a large-scale company given the mention of sales of antibody-based therapeutics totaling around $100 billion in the U.S. alone. The company is involved in the development of monoclonal antibodies (mAbs), which are currently the largest and fastest-growing class of biopharmaceutical. These mAbs undergo post-translational modifications (PTMs), including N-linked glycosylation, which modulates antibody activity and can affect a therapeutic antibody’s immunogenicity and pharmacokinetics. The company is seeking to understand how cellular conditions and biotechnical process parameters modulate N-glycosylation to establish robust manufacturing processes and safer therapeutics.
挑战
The biopharmaceutical industry is constantly seeking strategies to improve the quality and effectiveness of their products. One such strategy is the characterization and control of glycosylation patterns. However, the current gold standard for N-glycan mapping, ultrahigh pressure liquid chromatography (UHPLC) with a fluorescence-based detection method, presents several limitations. It loses site-specific information for molecules with multiple glycosylation sites, has issues with co-elution and new peak appearance, and requires laborious data processing, analysis, and reporting. The need for a more robust and high-throughput glycan analysis methodology led to the exploration of LC-MS glycopeptide mapping.
解决方案
The solution involved streamlining the data processing workflow of LC-MS glycopeptide mapping by automating the processing steps using Genedata Expressionist. This software allows for the detection of each targeted glycopeptide, automatically reports its mass-to-charge ratio and retention time, directly groups isomers (including newly discovered ones), and can visualize data at any point within the workflow. Users can also create “approved” workflows by blocking edits to selected parameters or the entire workflow, simplifying usage in routine monitoring and allowing the workflows to be used by non-experts. This method provides site-specific monitoring with no co-elution issues, identifies new peaks directly, and is suitable for complex molecules.
运营影响
数量效益
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