Early Assessments And Manufacturing Strategies To Maximize Success

By Rebecca Michael, PhD., Head of Cell and Molecular Biology, Lonza Early Development Services

Reducing attrition in drug development continues to remain an industry priority, especially as success rates show only 1 in 1,000 preclinical drug candidates actually make it to market. This is after significant investments in time and money ― an average of 12.8 years at a cost of $2.3 billion ― are made investigating them. Many of the failures in drug development are related to issues with safety and toxicology. However, early predictions about manufacturability, expression, and process development challenges based on a candidate’s sequence and structure can allow for modifications that increase the likelihood of a successful first-in-human (FIH) manufacturing campaign.

In silico and in vitro design and optimization serve as valuable tools in these assessments by not only identifying but also mitigating risks, ultimately optimizing early expression and material supply processes to improve developability of the candidate molecule. Download the full article to learn more about early-phase development challenges related to manufacturability, expression, and material supply; some details on how to perform early assessments; and examples of how Lonza has applied them to overcome development challenges.