Lonza, a global leader among contract development and manufacturing organizations (CDMOs), has unveiled Design2Optimize™, a next-generation platform designed to accelerate and streamline the process development of small molecule active pharmaceutical ingredients (APIs).
At the core of this innovative solution is an enhanced design of experiments (DoE) approach—a statistical framework that optimizes experimental setup by identifying the best reaction conditions from the start. This significantly cuts down development time and boosts efficiency.
Tackling API Complexity with Optimized Experimentation
The complexity of small molecule APIs has surged in recent decades. Many development pipelines now require twenty or more synthetic steps. Traditionally, researchers tested numerous routes and reaction conditions to reach the final product. This approach is both time-consuming and resource-intensive.
Lonza’s Design2Optimize™ platform addresses this challenge head-on by using optimized experimental design to extract maximum insight from fewer experiments. This results in faster decision-making, lower costs, and a streamlined path to scalable manufacturing.
Powering Innovation Through Advanced Modelling
Developed in collaboration with the Fraunhofer Institute for Industrial Mathematics (ITWM), the platform blends physicochemical and statistical modelling with a continuous optimization loop. This hybrid approach enhances chemical process development, even for complex or poorly understood reactions. It does so without requiring detailed knowledge of reaction mechanisms.
A key innovation is the creation of a digital twin for each process, enabling in silico scenario testing and predictive modelling. This reduces the reliance on physical trials, further accelerating development timelines while minimizing waste.
An Integrated Strategy for Faster Market Entry
Design2Optimize™ is a critical part of Lonza’s broader, integrated approach. It integrates seamlessly with Lonza’s AI-powered route scouting and high-throughput experimentation (HTE) capabilities. Together, they enable rapid testing, deeper process understanding, and smooth scaling from molecule design to clinical production.
Executive Perspective: Driving Transformational Change
“Lonza is transforming the development of small molecule APIs. We are advancing innovative offerings that enable faster development and optimization of synthetic API manufacturing processes,” 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,” Vertommen. According to the company press release, Lonza is redefining small molecule development with Design2Optimize™. The platform delivers smarter, faster, and more sustainable solutions for pharmaceutical innovators worldwide.
