Lonza Launches Design2Optimize to Accelerate Small Molecule API Development

• Lonza has launched Design2Optimize, a model-based platform to streamline the development of small molecule APIs.

• The new tool uses optimised design of experiments (DoE) and predictive modelling to reduce physical experiments and shorten development timelines.

Lonza, one of the world’s largest contract development and manufacturing organizations (CDMOs), has introduced Design2Optimize, a new platform aimed at improving the efficiency and speed of small molecule active pharmaceutical ingredient (API) development.

The platform uses an optimised design of experiments (DoE) strategy to minimise the number of physical tests required in API process development. By leveraging statistical and physicochemical modelling, Design2Optimize can help streamline reaction condition selection and reduce experimentation time.

Developed in collaboration with the Fraunhofer Institute for Industrial Mathematics (ITWM), the platform enables the creation of digital twins for chemical processes. This capability allows scenario testing in silico, even when reaction mechanisms are poorly understood, thereby enhancing process optimisation.

The launch comes as small molecule API development faces increasing complexity, with synthesis pathways often requiring more than 20 steps. Lonza’s approach combines the new platform with its AI-enabled route scouting and high-throughput experimentation (HTE) tools.

“Lonza is transforming the development of small molecule APIs by advancing innovative offerings targeting faster development and optimization of synthetic API manufacturing processes,” said Jan Vertommen, Vice President of Commercial Development, Advanced Synthesis at Lonza.

As a CDMO, Lonza aims to use this integrated approach to help drug developers move more quickly from candidate selection to first-in-human trials, while improving manufacturing readiness and process reliability.