Process Development

The ability in process development to take a chemical process previously run at a small scale and turn it into one that can be run at a much larger scale is an important skill. Many of Onyx's chemists have taken projects from the lab onto manufacturing plant in up to 10,000 litre reaction vessels and have a wide understanding of what is required. Even if we are only developing a process to make kilo quantities, our processes are potentially capable of being run at much higher scale than that.

Primary aims during process development are to increase yields and throughput and to make the process practical. Process development makes processes 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 will try to ensure that 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.

Specialist process development equipment is employed including reaction carousels for multiple parallel experiments and jacketed reactors. Automated multi-well systems are used where relevant. In addition to our chemists' experience we can also use specialist design of experiment and statistical software.

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