Lonza integrates advanced technology to simplify synthetic route identification for novel APIs
This offering aims to streamline the identification of synthetic routes for novel active pharmaceutical ingredients (APIs) by using Lonza's extensive chemical supply chain intelligence and in-house expertise, combined with AI technology from Elsevier (Reaxys).
The development pipeline for small molecule APIs is becoming increasingly complex, driven by the intricate structures of modern drug candidates. As a result, Lonza says, the number of synthetic steps required to produce these compounds is rising. This escalation in complexity can lead to longer lead times and the management of a larger array of raw materials, ultimately increasing the time and cost associated with developing an effective synthesis and potentially delaying clinical trial readiness.
The RSS integrates its process research and development (R&D) proficiency and comprehensive supply chain databases with AI-enabled computer-aided synthesis planning technology (CSPT).
By adopting the power of AI alongside global chemical supply chain intelligence, the company says this new offering delivers synthetic pathways that are not only more supply chain resilient but also offer insights for optimal route design for both clinical and commercial manufacturing. The integrated service provides valuable intellectual property, reduces costs of goods sold (COGS), and enhances supply chain security for customers.
Simon Wagschal, associate director of advanced chemistry technologies, small molecules R&D at Lonza, highlighted the significance of robust retrosynthesis in creating efficient and scalable syntheses for novel drug candidates.
Overcoming the challenge of rising API complexity
He said: “Today, researchers benefit from using CSPTs with analytical search and powerful predictive capabilities. By integrating our unique supply chain insights and predictions reflecting Lonza's decades of experience and knowledge of clinical and commercial manufacturing, global sourcing of raw materials and intermediates, our new Route Scouting Service helps chemistry, manufacturing, and control teams overcome the challenge of rising API complexity.”
Lonza's AI-enabled Route Scouting Service represents a significant step forward in the quest to expedite small molecule development and underscores the company's dedication to innovation and excellence in pharmaceutical manufacturing.
Juergen Swienty-Busch, director of product management for chemistry at Elsevier Information Systems is confident about the pivotal role played by Reaxys and its predictive retrosynthesis in Lonza's capability to deliver an extraordinary service.
“This successful implementation underscores our commitment to providing cutting-edge solutions that not only meet but exceed the needs of our customers and partners,” he said.
Optimal synthetic pathways identified
Making use of innovative technologies to accelerate route selection and process development, the RSS adopts a methodical, collaborative, and transparent approach.
Throughout each phase, process research and development experts use cutting-edge enabling technologies to identify optimal synthetic pathways for both clinical and commercial API manufacturing.
During phase 1, the company initiates the creation and systematic prioritization of synthetic route options, aligning them with partner-driven, predefined process ideals. Using expertise and its IP-enabled predictive cheminformatics, experts work to mitigate complexity and define efficient synthetic pathways.
Moving into phase 2, it consolidates sourcing intelligence to empower our partners in making strategic sourcing decisions for the routes identified as holding the greatest potential, both technically and commercially.
In phase 3, the process research and development team evaluates the effectiveness and performance of the top-rated process route candidates nominated by clients. Then Lonza subject matter experts (SMEs) use high-throughput experimentation robotics and draw from decades of development experience to expedite the reduction of risks, costs, impurities, and cycle times.
