De-Risk Your Journey To The Clinic: Overcome Manufacturability, Expression And Early Material Generation Challenges

Advancing your biotherapeutic candidate to the clinic is one of the most critical steps in development. This is the phase when you make key decisions that will have long-term scientific and business impact, frequently under extreme time and cost pressure. Manufacturability, expression and process development issues can be predicted very early in the development journey based on the candidate’s sequence and structure. This knowledge allows for modifications to the drug candidate and its process development to mitigate risk early and increase the likelihood of a successful first-in-human manufacturing campaign.

Rebecca Michael, Principal Group Leader, Early Development Services at Lonza Biologics, shares how in silico and in vitro design and optimization tools can help you not only assess but also mitigate risks and how to optimize early expression and material supply processes to enable optimal developability of your candidate. These activities are designed to ensure that early process development efforts are focused on key developability challenges to minimize scale-up risk. Case studies illustrate how these activities maximize the chances of success of your development journey.

Key learning objectives:

• Discover how in silico and in vitro design and optimization tools can help you assess and mitigate risks early
• Learn how to optimize processes for early expression and material supply to enable optimal developability
• Explore, though case studies, how these strategies maximize your chances of success