Ensuring Safety and Efficacy of Biotherapeutics Through In-Depth LC-MS Sequence Variant Analysis
Sequence variants are unintended amino acid substitutions that occur during the production of biotherapeutics. They are considered impurities in drug substances and may affect product quality adversely – leading to immunogenicity, drug efficacy and safety concerns.
The source of the variation can be caused by mutation or mistranslation in host cell lines, from codon homology, or as a result of unoptimized feeding strategies. As a result, significant effort is being directed towards the optimization of products and processes to ensure their levels are controlled.
However, sequence variants can be several orders of magnitude lower than the therapeutic in final products and because they are so closely related to the therapeutic, detecting and confirming them presents significant analytical challenges. To address these challenges, a sensitive liquid chromatography-mass spectrometry (LC-MS) workflow coupled with efficient data analysis software is critical for the detection and characterization of sequence variants in biopharmaceutical laboratories.
Attend this webinar to learn how:
- High-resolution MS can be used for a wide range of biopharmaceutical applications, including sequence variant analysis
- High quality MS2 spectra from the SCIEX X500B System offers key insights, with high confidence to mutation sites
- Protein Metrics software can be used to provide automated and flexible identification of low abundance sequence variants.
Presenter: Zoe Zhang (Application Support Senior Scientist, SCIEX)
