Navigating The BLA Pathway: A Guide To Analytical Characterization Of Complex Molecular Formats

By Karl Rogerson, Director R&D, Global Analytical Development, and Ian Anderson, Senior Principal Scientist, Global Analytical Development

The rapid growth of the monoclonal antibody (mAb) market demonstrates how crucial a broad range of scientific and engineering skills is in this dynamic market. Paired with a comprehensive and adaptable analytical strategy, drug manufacturers can face new technical challenges with confidence and realize the full potential of these therapies. This is especially vital for proving a product's safety, efficacy, and quality during the entire development process, from the investigational new drug (IND) application to the biological license application (BLA).

Using its decades of extensive experience with novel and complex molecular formats, Lonza experts outline case studies that underscore the need for a flexible and detailed strategy for drug analysis. Utilizing advanced tools and these best practices can not only increase the chances of achieving market approval but also unlock the full potential of these revolutionary therapies.

Read the full article from a leader in the field for more information about common challenges, bottlenecks, and solutions to enable a successful BLA through the lens of analytical characterization.