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This article features some of the most frequently used HPLC applications for the characterization of biopharmaceuticals.
Development and production of biopharmaceuticals is a growing segment of pharmaceutical industry. Therapeutic proteins include blood factors, thrombolytic agents, growth factors, interferons, interleukins, therapeutic enzymes and last but not least monoclonal antibodies. More than twenty monoclonal antibody (MAb) therapeutics have been approved for the treatment of a broad range of diseases including autoimmune, cardiovascular, infectious diseases and cancer. A thorough characterization of therapeutic biomolecules is a key task for the successful submission of research and production data for regulatory approvals of new drugs. Due to its high degree of automation, robustness and reproducibility liquid chromatography is the workhorse of the pharmaceutical laboratory. Therefore, HPLC is also frequently used when establishing analysis methods for biotherapeutics. This article features some of the most frequently used HPLC applications for the characterization of biopharmaceuticals.