Comparison between medicinal and process chemistry highlights some of the key differences between small scale research and scaling up – moving towards commercial production. Upon scaling up from laboratory research to larger scale production, there are a number of factors that need to be taken into consideration. Table 1 summarizes the SELECT criteria along with the associated considerations and potential issues.
|Criteria||Sub-criteria||Examples of Potential Issues|
|Exposure to harmful substances||Carcinogens, sensitisers|
|Environmental||Wasted resources||Quantity & variety of solvents|
|Substances harmful to the environment||Aquatic toxins, ozone depleters|
|Legal||Infringement of Intellectual Property||Competitor patenting key intermediate|
|Regulation of reagents and intermediates|
|Economic||Meeting Cost of Good (profit margin)||Long synthesis or expensive starting materials|
|Investment costs (equipment)|
|Control||Control of quality||Meeting specifications/ GMP|
|Control of physical/chemical parameters|
|Throughput||Time scale of manufacture||Long synthetic route|
|Availability of starting materials||Rare natural products|
Table 1: The SELECT criteria with associated potential issues.