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.View Resource
Almac API, Chemical Development, Analytical & Solid State Services
Almac Sciences provides integrated services from development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API).
We provide a range of services for small molecules (including highly potent) and peptides. We have a proven track record of saving time and cost through the integration of our services and application of innovative biocatalysis and technology solutions.
We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, potent and controlled substances.
Our vast pool of scientific knowledge can help to overcome the analytical challenges that typically arise during drug development.