Foundation: Introduction to process chemistry in the pharmaceutical industry

Summary and further reading

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 summarises 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.

Recommended reading: