Comparison between medicinal and process chemistry highlights some of the key differences between small scale research and scale 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 |
---|---|---|
Safety | Process safety | Explosions |
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.
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