Preliminary Program subject to change
15B03 Case Studies in Pharmaceutical and Biopharmaceutical Development
OverviewThis session requests papers in the areas of laboratory process development through scale-up to manufacturing of active pharmaceutical ingredients and drug products. Issues related to process development, scale-up, applications of new technologies and examples of successes/failures with regard to unit operations in API manufacture and drug product manufacturing are welcome.
Primary SponsorPharmaceuticals (15b)

Chair

Ram Narayan
Pharmaceutical Process development/Chemical Development
Pharmaceutical Process Development/Chemical Development
Roche Carolina Inc.
6173 Old Marion Highway
Florence, SC 29501
Phone Number: 843-629-4140
Fax Number: 843-629-4128
Email: ram.narayan@roche.com

CoChair

Billy Edwards
Pharmaceutical Process Development/Pilot Plant
Roche Carolina Inc.
6173 Old Marion Highway
Florence, SC 29501
Phone Number: 843-629-4266
Fax Number: 843-629-4128
Email: billy.edwards@roche.com
Process Safety Evaluation Using Non-Isothermal Calorimetry
Billy Edwards, Pharmaceutical Process Development/Pilot Plant, Roche Carolina Inc., 6173 Old Marion Highway, Florence, SC 29501, Thimma Rawalpally, Chemical Development, Roche Carolina Inc., 6173 Old Marion Highway, Florence, SC 29501 and Joshua Allen, Pilot Plant, Roche Carolina Inc., 6173 Old Marion Highway, Florence, SC 29501
Characterization and Filterability Studies for Tamiflu (Oseltamivir Phosphate) at Roche Carolina, Inc
Nolan Gregory1, Bert Miranda1 and Ram Narayan2, (1)Manufacturing, Roche Carolina Inc, 6173 E. Old Marion Highway, Florence, SC 29501, (2)Process Development, Roche Carolina Inc, 6173 E. Old Marion Highway, Florence, SC 29501
On the Sameness Criteria for the Particle Size Distributions
Nandkishor K. Nere, Purdue University, 1283, FRNY, 480 Stadium Mall Dr., West Lafayette, IN 47907, Rodolfo Pinal, Industrial and Physical Pharmacy, Purdue University, 575 Stadium Mall Dr., West Lafayette, IN 47907, Doraiswami Ramkrishna, School of Chemical Engineering, Purdue University, West Lafayette, IN 47907-1283 and Ram Narayan, Chemical Development, Roche Carolina Inc, 6173 E. Old Marion Highway, Florence, SC 29501
Development Of A Fluidized Bed Granulation Process: A Comparative Analysis With Two Different Formulations
Ecevit Bilgili1, Luke Schenck2, Kimberly Gallagher3, Heather Young4, Show Chen2 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)Solid Dosage Pilot Plant, Merck & Co., Inc., WP78-110, P.O. Box 4, West Point, PA 19486
Application of Population Balance Model to Tablet Coating Process
Steven H. Chan, Steve S. Y. Wang and San Kiang, Engineering Technology, Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, NJ 08903

Food, Pharmaceutical & Bioengineering Division