Department of Chemical Engineering, University of California Santa Barbara
"Digital Drug Product Design: From Crystal Structure to Process Structure"
Virtually all small molecular weight drugs are isolated as crystalline particles, and over 90% of all pharmaceutical products are formulated in particulate, generally crystalline form. Normally, the properties of the crystalline solid (especially polymorph and crystal shape) have a major impact on the functionality of the product as well as the design and operation of the manufacturing process, and in most cases the two cannot considered separately.
Batch processing is the traditional method for producing drug products, which suffers from several drawbacks, including batch-to-batch variability and high manufacturing costs. The major name-brand drug companies are becoming more interested in developing continuous manufacturing processes, but these too have their own challenges, particularly speed & cost of process development, and forbidden recycles. I will report on recent innovations for (1) polymorph selection by continuous processing, and (2) predicting crystal morphology for each polymorph. Some remaining challenges will be discussed.
Michael F. Doherty is the Duncan & Suzanne Mellichamp Chair in Process Systems Engineering and former Chemical Engineering Department Chair at the University of California Santa Barbara. He is a member of the National Academy of Engineering. He received his B.Sc. in Chemical Engineering from Imperial College, London and his Ph.D. in Chemical Engineering from Trinity College, University of Cambridge. His research interests include process systems engineering with particular emphasis on crystal engineering, and separation with chemical reaction. He is the holder of six patents, has published over 200 scientific papers and given over 250 invited lectures. He has received numerous honors and awards for his teaching and research, including the Alpha Chi Sigma Award for Chemical Engineering Research (2004) from the AIChE and the E. V. Murphree Award (2012) for Research in Industrial and Engineering Chemistry from the ACS. In 2008 he was named one of the “One Hundred Chemical Engineers of the Modern Era (post 1945) by the AIChE.