Our dedicated process chemistry team is committed to aiding you in route scouting and crafting a process tailored to your project's needs. This process guarantees safety, reproducibility, robustness, and superior quality. All our process development endeavors are guided by Quality by Design (QbD) principles, integrating analytical and risk-management methodologies throughout molecule design, development, and manufacturing stages.
The process begins with designing the route, which involves conducting retrosynthetic analysis, practical evaluation for yield enhancement, and ensuring safety through thorough thermodynamic studies. This leads to route investigation, encompassing in-depth exploration of potential routes and method development. The process is developed, optimizing both early and late-stage processes, employing strategically designed experiments (DoE), and troubleshooting reactions.
Navigating the transition from preclinical to commercial-scale manufacturing brings intricate challenges and intricacies. Our custom scale-up service encompasses in-house production ranging from hundreds of grams to kilograms of non-GMP material, serving demo batches, proof of principle, and preclinical studies. Seamlessly transferring technology to larger scales and ensuring GMP-compliant manufacturing is a pivotal aspect of our offering.
Leveraging a wealth of experience, our analytical specialists expedite the transformation of your molecule from conception to clinical stages and beyond with unwavering success. Complemented by abundant capacity and diverse analytical insight, we provide our clients unparalleled access to a team of genuine problem solvers well-versed in the entire product life cycle. With an arsenal of cutting-edge analytical and synthetic equipment, we excel in conducting meticulous impurity identification for drug substances.
Pioneering Efficiency Route scouting is foundational in identifying a safe, efficient, and cost-effective synthesis process for large-scale production. Key questions encompass safety considerations, raw material availability and affordability, patent implications, intermediate stability, purification methods, environmental concerns, and alternative routes derived from thorough literature reviews. Regulatory compliance is also weighed, shaping decisions that optimize time, cost, and quality. Our approach integrates these crucial aspects to formulate an optimized route.
Our integrated analytical support entails method development and synthesizing and purifying analytical standards to empower accurate analysis and quality assessment.
