Preliminary Program subject to change
TI012 Pharmaceutical Process Development Scale up and Implementation
OverviewThis session is devoted to the implementation of novel approaches taken to address challenging scale-up issues related to the pharmaceutical industry. Of particular interest would be the discussion of laboratory work performed to define the critical aspects of the synthesis and the corresponding approaches to their implementation at either the pilot plant or manufacturing scale.
Primary SponsorTopical I: Pharmaceutical Engineering for the 21^st Century (TI)
Co-Sponsor(s)Process Development Division (12), Pharmaceuticals (15b)

Chair

Sanjeev Katti
Director, Pharmaceutical Development Sciences
Genzyme
Drug Discovery & Development
153 Second Avenue
Waltham, MA 02451
Phone Number: 781-434-3496
Fax Number: 781-434-3636
Email: sanjeev.katti@genzyme.com

CoChair

Brent Nielsen
Senior Research Investigator
Process R&D
Bristol-Myers Squibb Company
One Squibb Drive
New Brunswick, NJ NJ/08903
Phone Number: 732 227-7971
Email: brent.nielsen@bms.com
Process Engineering Aspects of Plasmid-Based Biopharmaceuticals Production: Tackling the Threatening Vaccine Shortages to Prevent Global Pandemics
Michael K. Danquah, Bio-Engineering Laboratory, Chemical Engineering Department, Monash University, Wellington Road, Clayton campus, Melbourne, Victoria, Australia and Gareth M. Forde, Chemical Engineering, Monash University, Wellington Rd, Clayton, Melbourne, Australia
Continuous Thermal Epimerization in High Temperature Tubular Reactor
Amy Jines, Chemical Product Research and Development, Eli Lilly and Company, Inc., 1400 W. Raymond Street, Indianapolis, IN 46221
Continuous Newman Kwart Rearrangement In Thermal Tube Reactor
Martin Johnson, Chemical Process Research & Development, Eli Lilly &Co., Inc., 1400 W. Raymond St., Indianapolis, IN 46221
Controlling The Key Response Variables Through Scaling Rules During The Scale-Up Of A Fluidized Bed Granulation Process
Ecevit Bilgili1, Jeff Ko2, Adam Chen2, Edward Smith2, Pavol Rajniak2, Kyle Fliszar3, Gordon Wong4, Larry Rosen2, Daniel Grubb2 and Dafni Bika2, (1)Pharmaceutical Commercialization Technology, Merck Manufacturing Division, Merck & Co., Inc., WP78-110, P.O. Box 4, West Point, PA 19486, (2)Pharmaceutical Commercialization Technology, Merck & Co., Inc., WP78-110, P.O. Box 4, West Point, PA 19486, (3)Analytical Chemistry and Development, Merck & Co., Inc., WP78-110, P.O. Box 4, West Point, PA 19486, (4)Center for Materials Science and Engineering, Merck & Co., Inc., WP78-110, P.O. Box 4, West Point, PA 19486
Break
Development And Scale-Up Of Efficient Api Drying Using Fluid Bed Dryer
Yubo Yang, Jenny Lau, Ilaria Popolla, Gerrie Liaw, Melissa Ostberg and Stephen Tyler, Abbott Laboratories, 1401 Sheridan Road, North Chicago, IL 60064-6292
Quality Risk Analysis of a Tablet Coating Process
Steve S. Y. Wang, Steven H. Chan and San Kiang, Engineering Technology, Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, NJ 08903
Novel Scaling of Rotary Drum Film Coating Developed from Commercialization of Pharmaceutical Tablets
Alan R. Silverman1, Jeffrey Givand1, Brad Holstine1 and Michael Gentzler2, (1)Pharmaceutical Commercialization Technology, Merck & Co., Inc., PO Box 4 Sumneytown Pike, Mailstop WP78-110, West Point, PA 19486, (2)Center for Material Science and Engineering, Merck & Co., Inc., PO Box 4 Sumneytown Pike, Mailstop WP75B-210, West Point, PA 19486

Topical I: Pharmaceutical Engineering for the 21Century