Our process development chemists are able to provide route scouting, process development and optimization services based on QbD principles. We also can deliver grams to kilograms of APIs, key intermediates or regulatory starting materials to support pre-clinical or clinical milestones.
Explore a new synthetic route or re-design and optimize the current synthetic route to lower cost, control quality and improve process safety and scalability.
Synthesize, isolate, and characterize impurities, propose possible mechanisms of formation and develop impurity purging and control methods.
Quickly develop and optimize key reaction steps, using high throughput screening platforms where beneficial.
Address recalcitrant chemical steps using technologies including flow chemistry, photo chemistry, and enzymatic chemistry, for example.
Collect stability data, conduct abuse/stress tests and evaluate process safety using DSC, RC1e, and ARSST equipment.
Conduct PAR and NOR studies to support regulatory filings.
Technology transfer to internal or third-party production plants.
Please feel free to contact us if you have any questions.