Trends in the Analysis of Biopharmaceuticals by HPLC

Abstract

Background: Biopharmaceuticals are biological drugs consisting of a complex compound that can be produced by a living organism or derive from it. Biopharmaceuticals are very complicated compounds from structural point of view and for this reason, they cannot be fully characterized in terms of their structure with current analytical methods as it happens instead of low molecular weight chemicals drugs. Introduction: The regulatory guidelines require the characterization of the primary or higher sequence of these molecules and the characterization of any post-translational modifications. The use of biopharmaceuticals has really grown in the last few years: in 2016, the number of biopharmaceuticals approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for use in humans’ diseases was 1357. From 2013 to 2016, 73 of these compounds were approved for the treatment of cancer, inflammation, immune disorders, infections, anemia and cardiovascular diseases. Aim/Conclusion: The aim of the present review is to provide an overview of recent approaches for the characterization of biopharmaceutical products in HPLC that have been presented in the literature in the last years.

Capillary electrophoresis‐mass spectrometry for intact protein analysis: Pharmaceutical and biomedical applications (2018–March 2023)

“…Because of the natural complexity of biopharmaceuticals, there is a crucial need for superior analytical methods to provide a comprehensive in-depth characterization of these molecules, their variants, and degradation products. Besides traditionally established separation techniques based on liquid chromatography, such as SEC, RP-HPLC, IEC, and slab gel electrophoresis, such as sodium dodecyl sulfate (SDS)-PAGE and 2D-differential gel electrophoresis [57,62], CE offers numerous benefits and unique features of the separation mechanisms and therefore represents one of the most powerful tools for the characterization of biopharmaceuticals. CE can be increasingly found in all major pharmacopeias and techniques as CZE, CGE, and CIEF are recommended for the analysis of biopharmaceutical products during process development, characterization, and quality control.…”