Lonza has unveiled a new model-based development platform, Design2Optimize, which aims to streamline the process development of small molecule active pharmaceutical ingredients (APIs) and speed up timelines to clinical trials.

Developed in collaboration with the Fraunhofer Institute for Industrial Mathematics (ITWM), the in-house platform uses a model-based design of experiments (DoE) to identify optimal conditions for chemical reactions. By reducing the number of physical experiments needed to optimize synthetic routes, the platform helps drug developers cut time and resource use – an increasingly critical goal as API complexity rises.

According to Lonza, the typical small molecule API now includes over 20 synthetic steps. Rather than relying on broad empirical testing, the Design2Optimize platform integrates physicochemical and statistical models to predict outcomes more efficiently – even for complex or poorly understood reactions. A built-in optimization loop creates a digital twin of the process, allowing scenario testing without further lab work.

“Lonza is transforming the development of small molecule APIs by advancing innovative offerings targeting faster development and optimization,” said Jan Vertommen, vice president of commercial development, advanced synthesis at Lonza.

“With the rising complexity of APIs in mind, these new offerings aim to reduce the time it takes to move from early candidate selection to first-in-human materials.”

The platform complements Lonza’s existing suite of early-phase services, including its AI-enabled route scouting tool and high-throughput experimentation (HTE) workflows. Together, the company says, these capabilities form an integrated approach to help partners move more efficiently from molecule design to market.

Design2Optimize forms part of Lonza’s broader strategy to invest in early development services for small molecules, an area still seeing strong demand despite the rise of biologics.