Resource Library
Accelerating protein sequence variant analysis
The therapeutic implications of structural variants
The functionality and efficacy of antibodies and other therapeutic proteins are significantly influenced by their structure, which is mainly determined by the amino acid sequence. Errors in protein biosynthesis that lead to sequence variants (SVs) can result in protein misfolding, aggregation, and fragmentation. These variants typically arise from amino acid substitutions due to genetic mutations during cell line development (CLD) or amino acid misincorporations during upstream processing (USP). Read more
Structural variant detection during key phases of drug development
To address the limitations of traditional analysis in detecting and quantifying SVs, Samsung Biologics developed a cutting-edge LC-MS/MS methodology. This advanced method incorporates ultra-high-performance liquid chromatography (UHPLC) for rapid separations –– coupled with a high-resolution Orbitrap mass spectrometer for detection –– and uses a comprehensive protein characterization software for detailed analysis. The synergy between these high-end MS acquisition and data processing technologies allows for more precise and efficient detection of SVs, even at very low levels.
In this whitepaper, the application of this technology is detailed during two key development phases:
- Case study one: Detecting mutations during cell-line development
- Case study two: Detecting variants during upstream processing
The therapeutic implications of structural variants
The functionality and efficacy of antibodies and other therapeutic proteins are significantly influenced by their structure, which is mainly determined by the amino acid sequence. Errors in protein biosynthesis that lead to sequence variants (SVs) can result in protein misfolding, aggregation, and fragmentation. These variants typically arise from amino acid substitutions due to genetic mutations during cell line development (CLD) or amino acid misincorporations during upstream processing (USP). Read more
Structural variant detection during key phases of drug development
To address the limitations of traditional analysis in detecting and quantifying SVs, Samsung Biologics developed a cutting-edge LC-MS/MS methodology. This advanced method incorporates ultra-high-performance liquid chromatography (UHPLC) for rapid separations –– coupled with a high-resolution Orbitrap mass spectrometer for detection –– and uses a comprehensive protein characterization software for detailed analysis. The synergy between these high-end MS acquisition and data processing technologies allows for more precise and efficient detection of SVs, even at very low levels.
In this whitepaper, the application of this technology is detailed during two key development phases:
- Case study one: Detecting mutations during cell-line development
- Case study two: Detecting variants during upstream processing