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
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.