Q&A: An Inside Look At CMC Strategy Development For Novel Biologic Formats

An increasing number of complex, next-generation biologics in today’s development pipelines are fueling hope of addressing a wide range of unmet patient needs. However, despite their growing promise, these novel biologic formats present a host of challenges due to the product-specific requirements they present during development that cannot be addressed by platform approaches traditionally utilized for large molecules, such as monoclonal antibodies. Lonza, backed by decades of experience and an innovative toolbox of solutions, is focused on addressing the bottlenecks with these products, which comprise approximately 40% of the large molecules its teams supported in 2021. This Q&A session was held after the webinar "Tailored CMC Solutions that Meet the Needs of Novel Molecular Biologic Formats," where Andrew Brown, Head of Global Process Development Support, addressed questions from attendees about the information and case studies presented in the webinar.