Process Development

At some point in your project, you will require process development so rest assured in knowing we will listen to what you need, take the time to understand your project, advice where possible and create something that is fit for purpose.

With a rich manufacturing heritage, 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. Many of our scientist have taken process development projects from our custom-built R&D labs 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 endeavor to minimize the costs of each process. We will try to eliminate toxic reagents, avoid chromatography and minimize waste. Solvents will be chosen with regards 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.