Small molecule drug development is becoming increasingly complex. Molecules are larger, more three-dimensional, and must meet rising regulatory and market demands while reaching patients faster. To succeed, companies must adopt early phase, data-driven approaches that accelerate development and reduce risk.
A key step is selecting the right synthetic route early. Lonza’s Advanced Synthesis platform uses AI-enabled route scouting to combine computer-aided synthesis planning with real-world supply chain and pricing data. This ensures chosen routes are not only efficient but also commercially viable and resilient against disruptions.
Once routes are identified, high-throughput experimentation (HTE) enables parallel testing of many reactions, providing rapid insights into optimal conditions. Lonza’s robotic systems, including facilities for highly potent APIs, accelerate the discovery of scalable, robust processes. Complementing this, Lonza’s Design2Optimize™ platform builds on Design of Experiments (DoE), integrating modeling and data to predict outcomes and reduce experimental workload.
Solid form screening is another critical early step. By evaluating salts, polymorphs, and coformers with automated, high-throughput tools, and enhanced by AI-based conformer prediction, Lonza helps developers identify the most suitable solid forms quickly, reducing downstream risks.
Physiologically Based Biopharmaceutics Modeling (PBBM) then predicts how a drug behaves in vivo across populations and dosing conditions. Regulators increasingly accept PBBM in IND applications, and Lonza applies these models to de-risk customer assets and optimize formulations.
Together, AI route scouting, HTE, Design2Optimize™, solid form screening, and PBBM form an integrated toolkit that de-risks early development, accelerates timelines, reduces costs, and inspires investor confidence. Beyond chemistry, digital twins and self-optimizing platforms are extending these benefits into process development and manufacturing.
By enabling smarter, data-driven decisions from the start, Lonza helps biotech and pharma companies adopt a right-first-time mindset that delivers faster, more reliable access to life-saving therapies.