Shaping Biotherapeutics Development Programs Around Different CMC Paths

By Nathalie Knabe, Senior Director Strategic Marketing, Mammalian, Lonza

Getting to the clinic is a major milestone for biopharmaceutical companies. The drug development journey is long, expensive, resource straining, and risky, due to high attrition rates, and a large amount of data must be generated, collected, interpreted and correctly integrated for the First-in-Human (FIH)-enabling data package. When developing more complex formats, such as bispecific antibodies, fusion and recombinant proteins, you are likely facing even tougher technical challenges which can lead to longer timelines. As a biopharmaceutical company, you also face fierce competition from hundreds of other firms. How can you help your lead candidates get ahead of the pack?

Joining forces with an experienced, yet flexible, development and manufacturing partner could help your drug candidate reach those all-important milestones on time and on budget. Each journey to the clinic is unique, and building optimal paths that balance risk with time and costs is complex. This article discusses a flexible approach to create a program that is in sync with your molecule’s profile and your company and investors’ needs.