Scientific Article: Dealing with the challenges of post translational modification (PTMs)

What are PTMs?

Assessing PTMs

Monitoring PTMs is therefore both necessary for protein structural characterization as required by the international regulatory guideline ICH Q6B, but also from the point of view of assessing the quality of the protein product and the manufacturing/ purification processes. Unwanted PTMs can give rise to product related impurities, which also require investigation as described in ICH Q6B. The most effective means of PTM analysis by far is mass spectrometry. A combination of intact mass analysis and, critically, peptide mapping will give significant information on the nature and location of PTMs within any given product.

Assessing PTMS using Intact Molecular Weight

Assessing PTMs using Peptide Mapping

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