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. With this in mind, Andrew Brown, Head of Global Process Development Support at Lonza, recently hosted the webinar Tailored CMC Solutions That Meet The Needs Of Novel Molecular Biologic Formats. In it, he discusses Lonza’s integrated drug substance and drug product CMC strategy for novel molecular formats and other recombinant proteins. Brown also reviews technical case studies from process and analytical development that provide insight into how Lonza has delivered tailored, product-specific solutions and enabled the acceleration of novel molecular formats into the clinic. The following Q&A session was held after this webinar, where Brown addressed questions from attendees about the information and case studies presented in the webinar.