Lonza, a contract development and manufacturing organisation (CDMO), has announced the launch of its new Design2Optimize platform to enhance process development and manufacturing of small molecule APIs.
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Launch concept.
The platform is based on an optimised design of experiments (DoE), a statistical approach to process and reaction condition optimisation. With the goal of significantly accelerating the development timeline of small molecule APIs, the Design2Optimize platform represents a proprietary model-based approach that guides experimental setup based on optimal conditions.
Over the past two decades, the complexity of small molecule APIs in the drug development pipeline has steadily increased. As a result, 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 optimised experimental design to maximise information gain. The resulting input leads to a reduction in experiments needing to be performed, yielding improved efficiency.
The model-based platform combines physicochemical and statistical models with an optimisation loop to enhance chemical processes with fewer experiments than traditional statistical methods. Developed with the Fraunhofer Institute for Industrial Mathematics, the Design2Optimize platform 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. By significantly reducing experimentation time and resource use, Design2Optimize accelerates the path to manufacturing and increases the likelihood of right-first-time processes.
Combining the Design2Optimize platform with Lonza’s AI-enabled route scouting service and high-throughput experimentation (HTE) to rapidly test and compare reaction conditions, Lonza’s integrated approach streamlines development, enhances process understanding, and accelerates the journey from molecule design to market.
Jan Vertommen, vice president of commercial development, Advanced Synthesis, Lonza, said: “Lonza is transforming the development of small molecule APIs by advancing innovative offerings targeting faster development and optimisation of synthetic API manufacturing processes. 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.”