This preliminary program is subject to change.

Materials Characterization


Description:
Materials Characterization plays a critical role in QbD Pharmaceutical Process Development. A firm understanding of the properties of API and /or drug product intermediates can facilitate design of robust processes that consistently produce drug product with the desired quality attributes. Presentations that show the integration materials characterization into QbD drug product development are requested for this session.

Sponsor:
Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture


Chair:
Robert E. Yule
GSK
Process Engineering
Five Moore Drive
Research Triangle Park, NC 27709
Email: robert.e.yule@gsk.com

Co-Chair:
Shekhar Viswanath
Engineering Advisor
Eli Lilly and Company
Chemical Product Research and Development
Indianapolis, IN 46285
Phone Number: 317-277-4511
Email: VISWANATH_SHEKHAR@LILLY.COM


Papers:
Impact of Formulation Properties On Lubrication of Common Tableting Excipients
Benjamin J. Baranowski, Pfizer Worldwide Research and Development; Joseph Kushner IV, Pfizer Worldwide Research and Development
Agglomerate Characterization in Pharmaceutical Systems
Dushyant Shekhawat, Eli Lilly & Company
Development of API Target Attribute Profile
Weili Yu, Pfizer Inc.; Subodh Deshmukh, Pfizer Inc
Application of Materials Science Approaches to Facilitate Drug Substance and Product Processing
Thomas Borchardt, Abbott Laboratories; Raimundo Ho, Abbott Laboratories