509 Applications of Continuous Processing in the Manufacture of Pharmaceuticals: Drug Product I

Wednesday, November 11, 2015: 12:30 PM - 3:00 PM
Ballroom B (Salt Palace Convention Center)

As an advanced manufacturing mode, continuous manufacturing has been highlighted by the FDA’s regulatory science strategic plan (2011). Recently, the US president announced new actions to further strength US manufacturing (2014). Although the concept of continuous manufacturing has been widely used in some other processing industrial sectors, it is relatively new to the pharmaceutical sector. In this session, we invite submissions that discuss the most recent development in the following topics: (1) how classical chemical engineering concepts can be applied to process/equipment design and modeling for pharmaceutical continuous manufacturing of drug products, from unit operations to entire drug product manufacturing lines; (2) how advanced process control strategies such as innovative PAT can be applied for pharmaceutical continuous manufacturing process to ensure process consistency and drug product quality; (3) technical and regulatory challenges surrounding pharmaceutical continuous process. In addition, highly innovative applications of continuous manufacturing from other industrial sectors are welcome, too.

Pharmaceutical Discovery, Development and Manufacturing Forum
Pharmaceuticals (15B)
Huiquan Wu Email: huiquan.wu@fda.hhs.gov
Brian C. Anderson Email: Brian.C.Anderson@abbvie.com