The Synergistic Nature of Chemistry & Chemical Engineering Technology Teams Working Together in the Development of Post-Launch “2nd Generation” API Processes

Pharmaceutical manufacturers are under ever-increasing pressure to continually improve process performance and robustness for products in the post-launch phase due to both regulatory and economic pressures. In many cases novel process chemistries can be developed to manufacture the post-launch API molecules whilst simultaneously unlocking significant environmental, safety ,capacity and cost benefits. Pfizer has a program in place to introduce such new “2^nd Generation” API process routes to products in its post-launch phase product portfolio.

This talk highlights the synergistic nature of chemistry and chemical engineering teams working together to develop and commercialise these new API process routes. The roles of batch and continuous processing technologies, biocatalysis technologies, PAT and mathematical modelling from laboratory development to plant commercialisation will be presented. Some examples will be given of where engineering technologies have allowed otherwise inaccessible chemistries to be developed and commercialise. .