Resolving the Complexity of Combination Drug Product Design

The pharmaceutical community is entering an exciting era of new and evolving modalities, alongside innovative drug delivery systems. While these advancements offer opportunities to address health challenges, developing new modalities that target emerging therapeutic mechanisms introduces significant technical complexities. These multifaceted challenges require harnessing cutting-edge science to improve and save lives worldwide. The evolution of modalities and routes of administration, such as peptides, antibody-drug conjugates, T-cell engagers, nucleotide-based therapies, cell and gene therapies, ocular injections, and transdermal patches, has directly increased the complexity of drug delivery system requirements. These novel approaches demand a shift from traditional development platforms and manufacturing technologies, necessitating strategies to ensure efficacy, safety, and regulatory compliance. This presentation will address key technical considerations in developing biologics and explore the integration of API, formulation, device, analytical, and manufacturing functions to create robust products with optimal stability, bioperformance, and manufacturability. Complex examples, including nanobodies, bispecific and trispecific antibodies, Fc fusion proteins, and homodimers, will illustrate the challenges related to stability and impurities. Furthermore, artificial intelligence (AI) and machine learning (ML) are opening new avenues for pharmaceutical research and development. We will share insights on how AI and ML drive CMC innovations, accelerating the design of next-generation drug products. Together, we are redefining strategies and leveraging data-driven approaches to foster continuous innovation, while remaining committed to our mission of improving human health. In navigating the complexities of drug development, we must always ensure the delivery of high-quality, compliant clinical supplies to the right patients at the right time.