Plenary Session 4 - Resolving Complexity: Innovative Analytical Technologies for Characterization of Complex Modalities

In-depth analytical characterization of biological drugs and vaccines is important to aid in their development, and innovation in analytical technologies is crucial for the advancement of complex modalities. Biological therapeutic drugs and vaccines currently under development are often comprised of complex and multi-component/multi-functional modalities, that include multi-specific antibodies, antibody drug conjugates, conjugate and multicomponent vaccines, nucleic acid-based therapies and vaccines, genome editing therapies, viral vectors, cell therapies, blood products, and lipid-protein nanoparticles. The complexity of these modalities brings challenges to existing characterization approaches since different classes of biomolecules may require a diverse set of analytical methods for robust characterization. In addition, the large size and inherent structural heterogeneity of these modalities may lead to challenges in resolving product characteristics that may be relevant to clinical performance. Continuous innovation in the development of new analytical technologies and their application have enabled continued progress in the understanding of an ever-increasing array of these complex modalities. This session will focus on the technologies utilized for product characterization of complex modalities.