Which analyses should be part of mAb characterization?
I need to ensure the quality and consistency of my mAbs. Which analyses should I conduct for proper mAb characterization?
For several years, monoclonal antibodies (mAbs) have been the fastest-growing type of pharmaceutical molecules :
More than half of all new drugs approved from 2015 to 2018 were mAbs .
Also, the number of approved mAb biosimilars increased substantially during the last few years.
Before approval for clinical administration, biosimilars must be characterized in detail like their originator products .
What I suggest
Characterization of mAbs can be pretty complex. It is not enough to check for the correct amino acid sequence – you must also analyze the structure of the N-glycans and the proper formation of disulfide bridges .
We suggest a comprehensive and robust mAb characterization program based on intact mass analysis and peptide mapping to get the complete picture.
A mAb characterization program often consists of the following steps:
- Before and after reduction
- Before and after removal of N-glycans
- As subunits after IdeS treatment
- Application of single or multiple digests using proteases, such as Trypsin, Chymotrypsin, Asp-N, Glu-C, Lys-C, etc.
- Digestion under reduced and non-reduced conditions
- Detailed characterization based on the experimental data obtained by intact mass analysis and peptide mapping.
- A high level of protein chemistry expertise is necessary for this process.
This workflow provides a reproducible, accurate, sensitive, and fast structural assessment.
The solution is particularly beneficial to the biopharmaceutical industry. Pharma companies thus use it to control mAb product quality and consistency, batch-to-batch comparability, and process modification.
For more information about characterization analysis, visit our page dedicated to antibody analysis.
Related blog posts:
- How to characterize antibody glycosylation by HILIC-MS
- Why disulfide bridges are critical quality attributes of biologics
 Liu, J.K.H.: “The history of monoclonal antibody development – Progress, remaining challenges, and future innovations,” Annals of Medicine and Surgery, 2014
 Walsh, G.: “Biopharmaceutical benchmarks 2018”, Nature Biotechnology, 2018