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Figure 5: The overall process for manufacturing a biologics medicine
The manufacture of traditional small molecule medicines using a chemical synthesis route will be similarly complex. There are opportunities for improving manufacturing efficiency and resilience. The following are some examples:
Process intensification to simplify and shorten production processes. For example, moving from batch to continuous processing reduces the size and complexity of equipment. Importantly, continuous processes are more responsive to changing product demands. Smaller equipment is also easier to clean, and transfer or replicate in another location.
Process analytical technologies (PAT), measure the critical process parameters on plant instead of by remote analysis, bringing improvements in cycle time, process robustness and operational efficiency.