Biopharmaceutical drugs are playing an increasingly important role in the pharmaceutical industry. This evolution is accompanied by a wide diversity of molecules, including monoclonal antibodies and their derivatives, oligonucleotides, messenger RNA, as well as cell and gene therapies. Their size, structure, and complexity make their analysis particularly challenging. Yet in-depth characterization is essential to verify their identity, purity, and integrity, detect variants and impurities, and better understand the links between their properties and their biological activity.
This presentation will first cover the main families of biopharmaceuticals and the analytical challenges they raise. It will then show how different chromatographic approaches, with or without mass spectrometry, can contribute to their characterization. Examples will illustrate the complementarity of chromatographic modes, the development of rapid analyses, coupling with MS, and method automation.
Finally, the biopharmaceuticals of tomorrow are expected to become even more complex, particularly with the rise of conjugated molecules combining several types of compounds. This evolution will require the continued development of adapted analytical strategies capable of providing ever more comprehensive and reliable information.
