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CE Pharm 2007
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CE Pharm 2007Oct 14 - 18, 2007

Final Program: CE in the Biotechnology & Pharmaceutical Industries
October 14–18, 2007
Hyatt Regency Miami – Miami, Florida USA

Sunday, October 14, 2007
08:00 – 09:00  Registration – Lower Promenade
08:00 – 09:00  Breakfast in Hibiscus A
(For course attendees only)
09:00 – 15:00 Short Course Presentation: Applications of CE to the Analysis of Protein Therapeutics
Location: Hibiscus B
Presenters: Chantal Felten and Oscar Salas-Solano, Genentech, Inc., South San Francisco, CA USA
10:30 – 11:00 AM Break - Lower Promenade
12:30 – 13:30  Hosted Lunch in Hibiscus A
(For course attendees only)
15:00 Adjourn
 

Monday, October 15, 2007
06:00 – 08:00  Exhibitor and Poster Set-up in the Flagler/Monroe Ballroom
07:00 – 17:00  Registration in the Brickell Foyer
07:00 – 08:15 Breakfast in Tuttle South & Center
08:15 – 08:30  Welcome Address by Brian K. Nunnally, Wyeth Co-Chair – CE Pharm 2007
 

Protein Plenary Session in the Brickell Ballroom
Session Chairs: Brian K. Nunnally, Wyeth & Ilias Jimidar, Johnson & Johnson Pharmaceutical R&D

08:30 – 09:00  Simultaneous Characterization of N-Linked and O-Linked Glycans in Glycoprotein using CE
Melissa Hamm, Merck Research Labs, West Point, PA USA
09:00 – 09:30  Analysis of Glycosylated Type II IL-1 Receptor by Imaged Capillary Isoelectric Focusing (i-cIEF)
Mei Han, Amgen, Inc., Seattle, WA USA
09:30 – 10:00 Implementation of Quantitative Imaged Capillary Isoelectric Focusing Method in Quality Control Lab
Zara Safarian, Genentech, Inc., South San Francisco, CA USA
10:00 – 10:30 AM Break – Visit the Exhbitiors and Posters in the Flagler/Monroe Ballroom
10:30 – 11:00 Characterization and Quantitation of Therapeutick Monoclonal Antibodies using LabChip SDS Electrophoresis
Xiaoyu Chen, Amgen, Inc. Thousand Oaks, CA USA
11:00 – 11:30 DIY CE OQ
Hayley Sudeith, Baxter Pharmaceutical Solutions, Bloomington, IN USA
11:30 – 12:30  Roundtable Discussion
12:30 – 14:00 Hosted Lunch in Tuttle North, Center and South
12:45 – 13:45 Technical Seminar in Tuttle North
Agilent Technologies in Electrophoretic Separation Technologies: Current Status, New Developments and Future
Sponsored by Agilent Technologies, Inc.
 

Technical Seminar in Tuttle Center
TITLE - TBD
Sponsored by Beckman Coulter, Inc.

 

Technical Seminar in Tuttle South
Application Presentations by iCE280 Users
Sponsored by Convergent Bioscience

 

Carbohydrates Plenary Session in the Brickell Ballroom
Session Chair: Franka Kálmán, Solvias AG

14:00 – 14:30  Development of a High-Throughput Method for Carbohydrate Analysis of Monoclonal Antibodies by CE-LIF
Wendy Lau, Genentech, Inc., South San Francisco, CA USA
14:30 – 15:00 Development of Robust N-Glycan CE Test Methods Used for the Quality Control of Therapeutic Glycoproteins
Steffen Kiesseg, Solvias AG, Basel, Switzerland
15:00 – 15:30 Carbohydrate Analysis for Therapeutic mAbs and Proteins
Larry Rose, Xoma, Berkeley, CA USA
15:30 – 16:00 Roundtable Discussion
16:00 – 16:30 PM Break – Visit the Exhibitors & Posters in the Flagler/Monroe Ballroom
 

Nucleic Acids & Diagnostics Plenary Session in the Brickell Ballroom
Session Chair: SungAe Park, Amgen, Inc.

16:30 – 17:00 F-DOVAM-S Finds Virtually all Mutations at Higher Throughput and Lower Cost than Capillary Sanger Sequencing
Qiang Liu, City of Hope National Medical Center, Duarte, CA USA
17:00 – 17:30 Glycomic Profiling Through Capillary Electrophoresis as a Tool for Monitoring Cancer Progression 
Yehia Mechref, University of Indiana, Bloomington, IN USA
17:30 – 18:00 Roundtable Discussion
18:00 – 20:00 Exhibitor/Poster Evening Reception – Flagler/Monroe Ballroom
Co-Sponsored by Genentech, Inc. and Pfizer, Inc.
20:00 Adjourn
 

Tuesday, October 16, 2007
07:30 – 17:00 Registration in the Brickell Foyer
07:30 – 08:30 Breakfast in Tuttle South & Center
  Small Molecule Plenary Session in the Brickell Ballroom
Session Chairs: Oliver Grosche, Novartis Pharma KK and Kevin Altria, GlaxoSmithKline
08:30 – 9:00 CE for Small Molecule Analysis – Likely Future Developments
Kevin Altria, GlaxoSmithKline, Essex, United Kingdom
09:00 – 09:30 Ways to Improve the CE Method Performance
Cari Sanger, Solvay Pharmaceuticals, Weesp, The Netherlands
09:30 – 10:00 CE of Quaternary Ammonium Compounds
Raghvendra Sahai, EuTech Scientific Services, Highland Park, NJ USA
10:00 – 10:30 Application of CE in Small Molecule Drug Development: 1) Counter Ion Quantitation 2) Chiral Separation
Jay Xu, Arena Pharmaceuticals, San Diego, CA USA
10:30 – 11:00  Roundtable Discussion
11:00 – 11:30 AM Break – Visit the Exhbitiors and Posters in the Flagler/Monroe Ballroom
  CE-MS Plenary Session in the Brickell Ballroom
Session Chair: Stacey Ma, Genentech, Inc.
11:30 – 12:00

CE-MS in Pharmaceutical Analysis
Julie Schappler, University of Geneva, Geneva, Switzerland

12:00 – 12:30 On-Line CE-LIF-MS for Characterization of Antibody Glycosylation
Lynn Gennaro, Genentech, Inc., South San Francisco, CA USA
12:30 – 13:00 CE-MS: New Possibilities for the Characterization of Biopharmaceuticals
Ad De Jong, Utrecht University, Utrecht, The Netherlands
13:00 – 13:30 Roundtable Discussion
13:30 – 18:00 Lunch and Afternoon Beach Break – Attendees on own
18:00 – 18:30  Mini Evening Reception – Flagler/Monroe Ballroom
18:30 – 20:30 Workshops I & II
18:30 – 19:30 WORKSHOP I: Intercompany Collaboration: Rise of the cIEF
Location: Brickell Ballroom
19:30 – 20:30 WORKSHOP II: Method Validation and Troubleshooting
Location:  Brickell Ballroom
Moderators: Chantal Felten, Genentech, Inc. and Amy Guo, Amgen, Inc. Moderator: Brian K. Nunnally, Wyeth
20:30 Adjourn
 

Wednesday, October 17, 2007
07:30 – 17:00  Registration in the Brickell Foyer
07:30 – 08:30 Breakfast in Tuttle South & Center
  Regulatory Plenary Session in the Brickell Ballroom
Session Chair: Wassim Nashabeh, Genentech, Inc.
08:30 – 09:00 Subsequent Entry Biologics (Biosimilars/Follow-on Proteins) and the Importance of Analytical Physico-Chemical Techniques.
Michel Girard, Health Canada, Ottawa, Ontario, Canada
09:00 – 09:30 European Regulatory Aspects in Pharmaceutical Quality Control by Capillary Electrophoresis
Stefan Christians, Paul-Ehrlich Institute, Langen, Germany
09:30 – 10:00 Title TBD
Michelle Frazier-Jessen, MedImmune, Gaithersburg, MD USA
10:00 – 10:30 Japan Specifics When Submitting a CE Method
Oliver Grosche, Novartis Pharma K.K., Tsukuba, Japan
10:30 – 11:30 Roundtable Discussion
11:30 – 12:00 AM Break – Visit the Exhibitors and Posters in the Flagler/Monroe Ballroom
12:00 – 13:30 Hosted Lunch – Tuttle South, Center & North
Sponsored by Genentech, Inc.
  Emerging Issues Plenary Session in the Brickell Ballroom
Session Chair: C. Mark Lies, Beckman Coulter, Inc.
13:30 – 14:00  Analytical Comparability of Attempted Copies of Epoetins Using CE
SungAe Park, Amgen, Inc. Thousand Oaks, CA USA
14:00 – 14:30 CE for Assessment of Microbial Contamination
Dan Armstrong, University of Texas at Arlington, Arlington, TX USA
14:30 – 15:00 Accurate Charge Analysis for Drug Formulations
Tom Laue, University of New Hampshire, Durham, NH USA
15:00 – 15:30 Use of High Throughput Technology
Nathan Lacher, Pfizer Global Biologics, St. Louis, MO USA
15:30 – 16:00 Roundtable Discussion
16:00 – 16:30 PM Break – Visit the Exhibitors & Posters in the Flagler/Monroe Ballroom
  Late Breaking Plenary Session in the Brickell Ballroom
Session Chair: Brian K. Nunnally, Wyeth
16:30 – 17:00 Gel Electrophoresis for Quantitative Protein Impurity Analysis: SDS-PAGE, Gel                                      Chip and CE-SDS
                                    Zoran Sosic, Biogen Idec, Cambridge, MA USA
17:00 – 17:30 Immunoaffinity Capillary Electrophoresis for the Identification and Characterization of Toxic Biomarkers
Norberto Guzman, Johnson & Johnson Pharmaceutical R & D, Raritan, NJ USA
17:30 – 17:45  Closing Comments – Brian K. Nunnally, Co-Chair – CE Pharm 2007
17:45 Adjourn
 

Thursday, October 18, 2007
08:00 – 09:00 Registration – Lower Promenade
08:00 – 09:00  Breakfast – Lower Promenade
(For course attendees only)
09:00 – 15:00 Short Course Presentation:
Method Optimization and Troubleshooting in Capillary Electrophoresis
Location: Hibiscus A
Presenter: Kevin Altria, GlaxoSmithKline R & D, Essex, United Kingdom
10:30 – 11:00 AM Break - Lower Promenade
12:30 – 13:30 Hosted Lunch – Lower Promenade
(For course attendees only)
15:00 Adjourn

 

CE Pharm 2007

 

The goal of this Symposium is to provide a forum for the discussion of recent developments in CE analysis of protein, nucleotide and small molecule pharmaceuticals. The presentations and workshops will be devoted completely to practical concerns to strengthen the use of CE within the biotechnology and pharmaceutical industries. Applications will highlight uses of CE in various areas of product development including high throughput screening, formulation studies, process development, product characterization and validated lot release and stability testing. The Symposium will feature presentations from leading experts within the industries and the regulatory agencies (FDA, Health Canada). The workshops will allow for open discussions of specific techniques and/or applications including protein analysis, carbohydrate analysis, CE/MS, oligonucleotide and chiral separations as well as validation of CE assays for product release. Specifically, two workshops will focus on the implementation of assays, including assay troubleshooting, assay transfer, and instrument qualification (IQ/OQ/PQ).

 
Telephone: 510-428-0740
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