Pharmaceutical Technology Magazine
Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.
Protein therapeutics are a promising class of drugs that are increasingly coming to the fore in development pipelines as a result of their utility in difficult-to-treat diseases. Yet, these complex, large-molecule drugs pose significant challenges for developers and regulatory bodies alike.
An important issue for protein-based drug developers is that of structural characterization, which can help in understanding whether or not a drug product will be stable and of sufficient quality to be launched at all. “It is critically important that the complete and in-depth characterization of therapeutic proteins is performed throughout all stages of the drug discovery and development process,” says Simon Cubbon, senior global marketing manager, chromatography and mass spectrometry, Thermo Fisher Scientific. “Ultimately, this facilitates the transfer of appropriate knowledge throughout the pipeline, ensuring product consistency, safety, and efficacy.”