Process Chemistry versus Medicinal Chemistry: Summary and Further Reading

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. 

CriteriaSub-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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