(351b) Chemical Engineers in Pharma: Industrialization of Process Development and Other Future Directions (Area 15b Plenary Lecture)

Traditionally, chemical engineers have had a limited number of roles and influence in big pharma. As reflected in papers presented at the 2004 AIChE annual meeting, the role of the chemical engineer varies widely among pharmaceutical companies, from the traditional role on the manufacturing floor to differing degrees of involvement in drug substance and drug product process development.

Recently, the leadership of the FDA proposed a new paradigm for compliance with Good Manufacturing Practices (GMP) for ensuring the quality of pharmaceutical products, and for the way in which the FDA monitors and enforces GMP and quality compliance. The basis for the new paradigm is mechanistic process understanding and it has been strongly linked to the application of Process Analytical Technology (PAT) for real time monitoring and control of process variables. This in turn requires a deep mechanistic understanding of the process for which chemical engineers are uniquely qualified. Thus, the ?industrialization of Process Development? requires both the need for sufficient data to implement the process in manufacturing with automated process control, statistical process control, etc., and a new industrialized approach to studying processes and collecting larger amounts of data, both on the bench and at scale. This new paradigm has created a number of opportunities for chemical engineers to develop and apply chemometric models in process development and scale-up. Since modeling tools to predict thermodynamic and transport properties, to model unit operations, overall processes, the supply chain, etc. are more available and user friendly, chemical engineers can better interpret PAT data to develop and apply chemometric models describing pharmaceutical process. We can now contemplate a complete modeling environment where the design of new products and processes can start on the computer, as is the case in most other high-tech industries. Furthermore, chemical engineers are making inroads into modeling of drug absorption, drug transport, pharmacokinetics, toxicokinetics and pharmacodynamics. As these models are used together, pharmaceutical process development will enter a new era.