Lonza announced the launch of its new proprietary Design2Optimize platform to enhance process development and manufacturing of small molecule APIs.
The platform is based on an optimized design of experiments, a statistical approach to process and reaction condition optimization. It offers a proprietary model-based approach that guides experimental setup based on optimal conditions.
As the complexity of small molecule APIs in the drug development pipeline has increased, small molecule routes now often consist of at least 20 synthetic steps. Instead of testing many reaction conditions and synthetic routes to reach the final molecule, Lonza’s Design2Optimize platform addresses this challenge by using optimized experimental design to maximize information gain.
“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,” said Jan Vertommen, Lonza’s VP of Commercial Development, Advanced Synthesis.
The model-based platform combines physicochemical and statistical models with an optimization loop to enhance chemical processes with fewer experiments than traditional statistical methods. Developed with the Fraunhofer Institute for Industrial Mathematics, it helps drug developers to build predictive models at speed, even for complex or poorly understood reactions where the mechanism is not definitively known. By generating a digital twin of each process, the platform enables scenario testing in situ without the need for further physical experimentation.