We have an excellent track record in Process Development to take a chemical process previously run at a small scale to a much larger scale and support clinical programs.
A number of our chemists have taken Process Development projects from the lab onto manufacturing plants and a dedicated scale-up team in India enable us to identify scale-up challenges early on during tech-transfer. Even if we are only developing a process to make kilo quantities, our processes are potentially capable of being run at a much higher scale.
Primary aims during Process Development are to increase yields and throughput and to make the process scaleable, robust and reproducible. An absolute requirement is that the processes are safe. Moreover by eliminating expensive reagents we endeavour to minimise the costs of each process. We will try to eliminate toxic reagents, avoid chromatography and minimise waste. Solvents will be chosen with regard to their residual effects and for new APIs we ensure ICH guidelines are followed.
Where possible, we ensure sustainable processes are developed using ‘green chemistry’. We will try to convert stoichiometric processes to catalytic processes.
Integrating with our solid-state department, we can optimise final product isolation by developing conditions to produce crystalline material or if needed, isolation via salt formation.
