Which analyses should be part of mAb characterization?
I need to ensure the quality and the consistency of my mAbs. Do you have any advice on which analyses I should 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 has increased substantially during the last few years.
Before approval for clinical administration, you must show that you have characterized the biosimilar in detail, just like its originator product .
What I suggest
Characterization of mAbs can be pretty complex, though. 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:
- Can be used before and after reduction
- Applicable 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 is 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, I suggest you visit our page dedicated to antibody analysis. Here you can learn about the different analyses, e.g., assessing modifications like glycosylations and quantifying protein.
Related blog posts:
- Assessing and monitoring the quality of therapeutic mAb products
- How to identify peaks observed by UV-HPLC in stability studies
 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