Bioanalysis Zone

Characterization and QC of biopharmaceuticals by MS-based ‘multi-attribute method’: advantages and challenges

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Over the past 30 years, the market of biopharmaceuticals has grown rapidly due to the demand for new biotherapeutics. Because of the potential market value of tens to hundreds of billions of dollars, and higher approval rate (approximately threefold over small-molecule drugs), more companies are becoming actively involved in development of biopharmaceuticals and biosimilars. A majority of the biopharmaceuticals are protein therapeutics including monoclonal antibodies, vaccines, hormones and so on, which are commonly produced by recombinant DNA technology.Differing from small-molecule pharmaceutics, protein biotherapeutics have unique characteristics such as:

  • Larger molecular sizes;

  • Molecular heterogenecity due to post-translational or post-production covalent modifications;

  • Higher order structure changes upon modifications;

  • Aggregations caused by misfolding.

All these structural characteristics contribute to the safety and efficacy of the protein biopharmaceuticals, and therefore it is critical to characterize the biotherapeutics at various levels during drug discovery, development and quality control (QC) stages [1,2].

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