Drug Development

Medicinal chemists are, rightly so, not particularly interested in the method used to make their new lead compound. They're only interested in the compound itself and it's biological effect. When more of the drug is needed for further development and testing, the in-house process development chemist or external supplier company is often contracted. Drug development, process development, scale-up and kilo production, for example, are quite different chemical skills to medicinal chemistry. The pharmaceutical company is wise to concentrate their chemists on medicinal chemistry and out sourcing drug development to the specialists.

Drug development is a particular strength of Onyx Scientific Ltd. Our chemists have had many years experience of scaling up medicinal chemistry processes. Proper drug development aims to develop efficient, economic and sustainable processes that are safe and robust. Yields need optimising, stages can be telescoped together and chromatography is avoided. Drug development also involves determining and setting new specifications for the drug itself that will ultimately meet international regulatory requirements.

During drug development a compromise is essential. Processes need to be developed so that they can deliver appropriate quality drugs. However, the main focus is not to expend too much time and resources at this stage as the drug might probably fail at the next stage of development. Knowing where to stop is an important talent - balancing the need to develop the process with satisfying the need to produce material for testing.

Drug development takes a chemical process through various steps of increasing scale. Originally at a gram level, the processes are typically then run through at hundreds of gram scale, followed by production in kilo quantities. At each larger stage of drug development more problems arise and more problems are solved. Thus we arrive at a (multi stage) process that is capable of reasonable reproducibility and can be used to make enough to satisfy testing at that particular stage. Typically, for Phase 1 clinical trials, effective drug development results in a few Kilos of the drug. Phase 1 trials require the drug to have been made to current Good Manufacturing Practice (GMP) standards. GMP systems are operated at Onyx Scientific.

Onyx Scientific is "among the best chemical development talent in Europe" (Competitor)