Assessing and monitoring the quality of therapeutic mAb products

Antibody characterization
Alphalyse
Nov 25. 2019

Question:

 
I need to ensure the quality and consistency of my mAbs. Which analyses should be conducted?
 

Answer:

 
For several years, monoclonal antibodies (mAbs) have been the fastest growing type of pharmaceutical molecules [1]:

More than half of all new drug approved from 2015 to 2018 were mAbs [2].

Also, the number of approved mAb biosimilars increased substantially during the last few years.

Before biosimilars can be approved for clinical administration, they must be characterized in detail like their originator products [2].
 

What I suggest

Characterization of mAbs can be quite complex. It is not enough to check for the right amino acid sequence – you must also analyze the structure of the N-glycans and the correct formation of disulfide bridges [2].

To get the full picture, we suggest a comprehensive and robust characterization program based on intact mass analysis and peptide mapping.
 

A characterization program often consists of the following steps:

Intact mass analysis

  • Before and after reduction
  • Before and after removal of N-glycans
  • As subunits after IdeS treatment

Peptide mapping

  • Application of single or multiple digest using proteases, such as Trypsin, Chymotrypsin, Asp-N, Glu-C, Lys-C etc.
  • Digestion under reduced and non-reduced conditions

Data analysis

  • Detailed characterization based on the experimental data obtained by intact mass analysis and peptide mapping.
  • A high level of protein chemistry expertise is needed for this process.

 
This workflow provides a reproducible, accurate, sensitive, and fast structural assessment.

The solution is particularly beneficial to the biopharmaceutical industry to control mAb product quality and consistency, batch-to-batch comparability and process modification.

For more information about characterization analysis, download this application note:

mAb Application Note >>>

 

Related blog posts:

 

References:

[1]          Liu, J.K.H.: “The history of monoclonal antibody development – Progress, remaining challenges and future innovations”, Annals of Medicine and Surgery, 2014

[2]          Walsh, G.: “Biopharmaceutical benchmarks 2018”, Nature Biotechnology, 2018

About Alphalyse

Alphalyse uses expertise in the field of protein chemistry and bioinformatics, combined with top-of-the-line mass spectrometry equipment, to provide protein analysis services globally.

Alphalyse aims to deliver high quality data and customer service to all of our clients in a fast and convenient way.

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