Chemistry

Process development

From medicinal chemistry route to scalable process

At Novalix, we are able to efficiently integrate the experience of discovery chemists with the constraints of process chemistry.

Rapid implementation, new processes, removal of bottlenecks and shorter synthetic routes lead to reduced capital investment and lower cost of goods. Our chemists design and develop safe, economic, robust, reproducible and scalable synthetic routes.

Paper Route Design

Objectives: identify original and scalable synthetic routes.

Activities: our team delivers a detailed report that maps and evaluates possible synthetic routes to the target molecule. This report provides a guide for the next steps during the development of production processes. The creativity of our PhD chemists is complemented by the latest AI-based retrosynthetic tools.

Deliverables: exhaustive report including evaluation of relevant routes.

Route Scouting and Selection

Objectives: determine feasibility of routes or unlock key steps.

Activities: laboratory evaluation of the most promising routes in parallel enables rapid selection of the best route. We have established a robust process using internally developed screening platforms. In this critical process research stage, any concerns or potential problems will be identified, addressed and fully reported.

Deliverables: detailed synthesis report, reference sample.

Process Optimization

Objectives: provide a process-ready route.

Activities: Novalix has considerable experience of transferring processes to CDMOs, including GMP facilities.
Synthetic concepts are transformed into robust, reliable and cost-effective production processes that conform to industrial constraints. Scale-up and safety concerns are addressed. Flow chemistry is considered where appropriate.

Deliverables: detailed optimization report, representative sample (> 100 g).