Peptide mapping is a widely used structural characterisation test for biopharmaceuticals and accepted as one of the principle tests for identity confirmation in support of regulatory submissions (and for lot release purposes).
It’s a very powerful technique that can identify single amino acid changes that can result from point mutations. As such, validated peptide mapping methods can also be applied to the evaluation of genetic stability of product producing cell lines.
Read more in our recent Almac Voice from Peter Smith, Technical Leader Mass Spectrometry, Almac Sciences.
