Pharmaceutica Analytica Acta

Abstract

The Challenges of Biopharmaceutical Products for Analytical Requirements

Bruno Sarmento

Biopharmaceuticals drugs are a class of therapeutics enclosing recombinant therapeutic proteins, engineered antibodies and genetic material. Biopharmaceuticals have acquired a key role in the treatment of various diseases such as diabetes, several types of cancer, and inflammatory diseases. They are attractive medicines in the medical point of view, but technologically they face major challenges, starting by their inapt chemical and physical instability. Forms of chemical degradation include deamidation, isomerization, hydrolysis, racemization, oxidation, disulfide formation and β-elimination. Physical stability is generally defined as the ability of a protein to retain at least its tertiary structure that is crucial for biological activity.