Integrated Bioanalytical Techniques for Assessment of some Monoclonal Antibodies

Abstract

Over the past two decades terms such as ‘biopharmaceuticals’ and ‘biotechnology medicines’ have crept into the pharmaceutical vocabulary. Biopharmaceuticals are medicinal products such as vaccines, blood components, hormones, growth factors or recombinant therapeutic proteins and antibodies that are used to treat a disease [1]. Biopharmaceuticals were first used in the 1980s and came to describe a class of therapeutic proteins produced by modern biotechnological techniques, specifically via genetic engineering. This class refers to a protein or nucleic acid based pharmaceuticals used for therapeutic or in-vivo diagnostic purposes, which are produced by means other than direct extraction from natural (non-engineered) biological source [2]. Recombinant therapeutic proteins have gained enormous importance for clinical applications. They can be human protein replacements e.g. insulin, therapeutic agents for human diseases e.g. interferon (IFN), or prophylactic agents e.g. recombinant vaccines. Today, biopharmaceutical products have diverged to encompass not only recombinant forms of natural proteins and biologics derived from natural sources, but also monoclonal antibody (mAb)-based therapeutics [3,4].