Accelerating the Path to Clinic - How Material-Sparing Science Delivers FIH Formulations in Just 6 Months

In today’s fast-paced pharmaceutical landscape, the pressure to move from candidate selection to First-in-Human (FIH) trials has never been greater. But how do you balance speed with the need for a robust, commercially relevant product?

We’ve just released a comprehensive summary of our recent webinar featuring Cindy Chung, PhD, Principal Engineer at Serán Bioscience. In this session, Dr. Chung reveals the Right from the Start™ CMC paradigm, a science-first approach that leverages material-sparing bench work to define the manufacturing design space before you ever hit the pilot plant.

Key highlights from the article include:

• The 6-Month Milestone: How to achieve an advanceable, scalable formulation just six months after candidate selection.

• Tablet Compression Excellence: Using Compaction Simulators and CTC Profiles to understand manufacturability risks like sticking or microcracks using only grams of material.

• Predictive Dry Granulation: Utilizing the Sousa Model to accurately predict Roll Force and achieve parity between bench-scale slugs and process-scale ribbons.

• Early Risk Mitigation: Using Accelerated Predictive Stability (APS) and Developability Classification Systems (DCS) to inform packaging and technology selection early in the lifecycle.

Learn how to build a clear line of sight to commercial success from day one.

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‍Authored by

Cindy Chung, PhD

Principal Engineer

Process & Product Development

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