Image
Quality Assistance Biacore Webinar mAbs monoclonal antibodies

1D & 2D-LC/MS characterisation of mAbs for QC and stability testing

File

Access this 45 minute webinar to learn how state-of-the-art LC/MS technologies can be implemented for the efficient study of monoclonal antibodies using analyses optimised for each level of information you need (from intact protein to peptides/amino acids). Analytical performance of the different solutions proposed have been discussed, together with the presentation of numerous experimental results (with advantages and drawbacks) obtained during method development and optimisation.

Mass spectrometry is a very powerful technique widely used for the characterisation of biopharmaceuticals. 
Thanks to innovations in both hardware and software, this technique can now be implemented routinely. 

We presented versatile and efficient approaches for monoclonal antibodies, based on three levels of analysis: Intact protein, mAb substructures (after IdeS / FabRICATOR digestion), Peptide mapping after trypsin digestion

These were optimised in terms of sample preparation, LC separation (1D and 2D-LC), data processing / reporting

for mAbs isoform characterisation (batch-to-batch consistency, assessment of critical quality attributes, PTMs, glycosylation) and stability monitoring (mainly degradation by deamidation and oxidation). 

The performances and limitations of the different analytical approaches have been discussed, together with the advantages and drawbacks of the different LC columns and enzymes used. Particular attention will be paid to low pH trypsin digestion to minimise deamidation and oxidation for peptide mapping experiments. 
Thanks to the use of state-of-the-art analytical technologies, these reliable, sensitive and reproducible analyses can be done in a GMP regulated environment for QC and stability studies of biotech products.

Date
Authors
Quality Assistance
Resource type