Trends in the Analysis of Biopharmaceuticals by HPLC

Background: Biopharmaceuticals are biological drugs consist in complex compound that can be produced by a living organism or derive from it [1]. Biopharmaceutical are very complicated compounds from the 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 for low molecular weight chemicals drugs [2]. Introduction: The regulatory guidelines require the characterization of the primary or higher sequence of these molecules and the characterization of any post-translational modifications [3]. 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 [1]. Aim/Conclusions: The aim of present review is providing an overview of recent approaches for the characterization of biopharmaceutical products in HPLC that have been presented in the literature in the last years.