Preliminary Program subject to change
15B05 Innovations in Biopharmaceuticals
OverviewThis session addresses advances in biopharmaceutical manufacture, and compliance with regulation. Especially of interest are submissions in the area of scale down and establishing process comparability.
Primary SponsorPharmaceuticals (15b)

Chair

Gregory Frank
Amgen
MS 30W-2-A
One Amgen Center Drive
Thousand Oaks, CA 91320
US
Phone Number: 805-447-0365
Email: gfrank@amgen.com

CoChair

Sigma S. Mostafa
Research Scientist
Eli Lilly & Company
1223 W. Morris Street
Indianapolis, IN 46221
Phone Number: 317-276-6961
Fax Number: 317-276-5499
Email: sigma_mostafa@lilly.com

CoChair

Stelios C. Tsinontides
Director
Global Process Development
Cephalon, Inc.
145 Brandywine Parkway
West Chester, PA 19380
Phone Number: 610 883-5659
Fax Number: 610 738-6315
Email: stsinont@cephalon.com
Implementing An Automated Reactor Sampling System For Monitoring Cell Culture Bioreactors
Lauren Speciner1, George Barringer2, Joseph Perez3, Chris Grimaldi3, Richard Reineke3 and Adeyma Arroyo1, (1)Process Development Engineering, Genentech, Inc., One DNA Way, South San Francisco, CA 94080, (2)Groton Biosystems, Boxborough, MA 01719, (3)Genentech, Inc., One DNA Way, South San Francisco, CA 94080
Scale-up and Optimization of a Manufacturing Process for the Production of a Recombinant Cytotoxic Therapeutic Protein from An Escherichia Coli Expression System
A. Premsukh, J. Cizeau, R. Kolesar, D. Manoosingh, G. MacDonald, N. Glover and Denis Bosc, Viventia Biotech, Inc., 147 Hamelin Street, Winnipeg, MB R3T 3Z1, Canada
Evaluation of Continuous Solids Discharge Centrifugation for Biopharmaceutical Recovery
Gregory S. Stimpfl, Research and Development, Amgen, Inc., One Amgen Center Drive, B18S-1-A, Thousand Oaks, CA 91320
Current Advances In Design And Development Of Downstream Processes For Purification Of Monoclonal Antibodies
Hans J. Johansson, R&D, Life Science, GE Healthcare Bio-Sciences, Bjorkgatan 30, Uppsala, 75326, Sweden and Kjell Eriksson, GE Healthcare Bio-Sciences, Bjorkgatan 30, Uppsala, 75326, Sweden
Innovations in Ultrafiltration Technology in Biopharmaceutical Processing
Jon Petrone, Technical Support Group, PALL Life Sciences, 50 Bearfoot Road, Northborough, MA 01532
Process Development Approach To Assess The Effect Of Formulation And Filling Processes On Physical Stability Of Biological Liquid Formulations
Rajiv Mahajan, Mark Walker, Elyse Walker, Pk Yegneswaran and David J. Geer, Sterile and Liquids Development, Merck & Co, Inc., WP78-204, PO Box 4, West Point, PA 19486
Strategic Implementation of Single-Use Technology in Fixed Equipment Scale up Facility
Bryan V. Pingitor, Process R&D, Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, NJ 08903

Food, Pharmaceutical & Bioengineering Division