Thursday, November 8, 2007: 8:30 AM-11:00 AM
M - Salon D (Marriott Salt Lake City-Downtown)

Topical I: Pharmaceutical Engineering for the 21^st Century (TI)

#553 - Pharmaceutical Process Development Scale up and Implementation (TI012)
This 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.
Chair:Sanjeev Katti
CoChair:Brent Nielsen
CoSponsor(s):Process Development Division (12)
Pharmaceuticals (15b)
8:30 AM553aProcess Engineering Aspects of Plasmid-Based Biopharmaceuticals Production: Tackling the Threatening Vaccine Shortages to Prevent Global Pandemics
Michael K. Danquah, Gareth M. Forde
8:50 AM553bContinuous Thermal Epimerization in High Temperature Tubular Reactor
Amy Jines
9:10 AM553cContinuous Newman Kwart Rearrangement In Thermal Tube Reactor
Martin Johnson
9:30 AM553dControlling The Key Response Variables Through Scaling Rules During The Scale-Up Of A Fluidized Bed Granulation Process
Ecevit Bilgili, Jeff Ko, Adam Chen, Edward Smith, Pavol Rajniak, Kyle Fliszar, Gordon Wong, Larry Rosen, Daniel Grubb, Dafni Bika
9:50 AM Break
10:00 AM553eDevelopment And Scale-Up Of Efficient Api Drying Using Fluid Bed Dryer
Yubo Yang, Jenny Lau, Ilaria Popolla, Gerrie Liaw, Melissa Ostberg, Stephen Tyler
10:20 AM553fQuality Risk Analysis of a Tablet Coating Process
Steve S. Y. Wang, Steven H. Chan, San Kiang
10:40 AM553gNovel Scaling of Rotary Drum Film Coating Developed from Commercialization of Pharmaceutical Tablets
Alan R. Silverman, Jeffrey Givand, Brad Holstine, Michael Gentzler

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