Marketing authorization is a pivotal milestone toward commercialization of medicines that requires a well-defined sequence of process validation activities. However, shorter overall timelines caused by acceleration of the launch for various reasons (fast-tracked designations, first to market and other) challenge the historically defined chronological stepwise approach. This is exacerbated by a highly diverse set of molecules produced in microbial and calls for customized solutions.
In this on-demand webinar, discover how Lonza designs Late-Stage programs to specific customer requirements. Applying its novel, flexible, fast-track 5-step approach in close collaboration with customers to understand individual timeline requirements, technical and CMC readiness as well as tolerance to risk. We will show how our in-depth knowledge of microbial processes and our unparalleled understanding of process characterization can be used to design targeted Biologics License Application (BLA) programs that can be executed effectively, while managing risks for the objective of achieving a quick regulatory pass.
Learn about our process characterization and validation experts, the key role they play in developing and coordinating our fast-track process characterization programs and validation batches, and how they leverage their knowledge and expertise to manage project risks and realize timelines. We also describe how our Global Biologics Technical Development (GBTD) organization, was implemented at Lonza to drive a consistently high standard across the Biologics Division and excels in tackling complex technical problems, develops innovative solutions to process development, characterization, and manufacturing challenges.