Liquid Chromatography
High-resolution mass spectrometry for evaluation of identity and the post-translational modification (PTM) landscape of biologics is an emerging best-practice. This technology offers precise identification of proteins of interest and structural and functional modifications that impact gene and cell therapies. Subject Matter Experts in the BioAnalysis LCMS team are well versed in characterizing diverse gene and cell therapy modalities.
Clients can expect accurate, high resolution mass spec analyses and clear interpretation. Dedicated GMP-compliant Mass Spec analyses are available. Our LCMS protocols provide a complete understanding of proteins of interest, relevant modifications and residual protein profiles of biologic samples. This deep understanding, along with our ability to run LCMS analyses in GMP, is crucial for assessing the critical quality attributes of biologic drug products.
Popular Services
Peptide Mapping
The primary amino acid sequence of the capsids in your Gene Therapy, manually verified by BioAnalysis Subject Matter Experts.
Intact Mass
Assess capsid protein (VP1:VP2:VP3) ratios and capsid molecular weights. Intact mass provides a mass accuracy accurate to the low parts per million (ppm) range.
Host Cell Protein (HCP)
Rely on stringent MS/MS evaluation, relative and consistent quantitation, and in-depth analysis of the identified HCPs.
Post Translational Modifications (PTMs)
In addition to serotype sequence information, post-translational modifications are identified and quantified to inform gene therapy critical quality attributes.
Additional LCMS capabilities
Therapeutic mRNAs, Guide RNAs, Lipid Nanoparticles (LNPs), Vaccine Characterization