Accelerated development of novel therapeutics in an increasingly competitive and closely regulated scenario requires the use of progressive, high-throughput analytical platforms. Increasing structural complexities of emerging biopharmaceuticals such as bispecific antibodies, fusion proteins, antibody-drug conjugates, etc. underline the need for enhanced selectivity and resolution of conventional chromatography-based assays. With the progression of innovations in hardware and software, mass spectrometry has now become a gold standard for the characterization of therapeutic proteins and peptides. Mass spectrometry has immense potential to provide deeper and assured information about even the minute changes such as deamidation, which may occur at a specific site in the amino acid sequence of a peptide and/or protein. Thus, peptide-mapping-based multi-attribute-method (MAM) for characterization of site-specific chemical modifications or special applications such as hydrogen-deuterium-exchange (HDX) and native LC-MS for higher order structural studies and evaluation of drug-target interactions, are demonstrating their potential to complement and/or replace the conventional analytical toolbox for characterization of biopharmaceuticals. Future applications of LC-MS can be foreseen to be focused on the quantification of biologics, replacement/complementing ligand-binding assays, etc. In terms of instrumentation and data processing, there is enormous scope for rapid sample preparation with automated technologies, improved sensitivity, and resolution, especially for top-down analysis along with faster and more efficient data processing in-line with regulatory requirements.
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Article by: Amita Puranik (Research Scholar, Institute of Chemical Technology Mumbai)
