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 |
---|---|---|
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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