Opening Keynote: Addressing Pharmaceutical Process Development Challenges

Schedule

Mauricio Futran, Rutgers University

The Pharmaceutical Industry is undergoing major changes. More than $100 Billion in patent protected products are facing generic competition this decade. One of the most important changes in “Big Pharma” is an evolution from the vertically integrated model to a distributed one, where innovation, project execution and manufacturing are outsourced, often to Asia. Pharmaceutical process development and manufacturing are included in this trend. The new Pharmaceutical supply chain spans the globe, and involves companies with varying degrees of technical sophistication and operational discipline. Ensuring the supply and quality of pharmaceutical products requires a renewed emphasis on acquiring fundamental understanding during development so that the process can be controlled effectively in this array of suppliers. Furthermore the time and cost of development must be reduced.

This environment represents an opportunity for the academic community to contribute to the science and technology needed in process development and manufacturing, partnering with Industry along the way. While the FDA has created their “Quality by Design” initiative, it is not possible for every company around the world to develop this independently. The talk presents examples of current and potential academic contributions, such as dynamic analysis for process control, the science of particulate systems and the development of continuous manufacturing for solid oral dosage forms, and perspectives for the use of continuous approaches in developing bio-manufactured products.