This is a preview of the Biologics & Biotechnology Track at USP\'s Annual Science Meeting in Toronto during the week of September 22, 2009. To get the full meeting details, visit www.usp.org/meetings

1. September 22-25
Toronto, Ontario - Canada
Sheraton Centre Toronto Hotel

2. Welcome!
Track III: Quality of Manufactured
Medicines – Biologics and Biotechnology
Wednesday, September 23, 2009
Session I: 10:30 a.m. to 12:30 p.m.
Session II: 2:00 p.m. to 4:30 p.m.
Thursday, September 24, 2009
Session I: 10:30 a.m. to 12:30 p.m.
Session II: 2:00 p.m. to 4:30 p.m.
SEPTEMBER 23-25 | TORONTO, ONTARIO - CANADA | SHERATON CENTRE TORONTO HOTEL

3. Biologics and Biotechnology Track: Scope
• The Track will discuss the following:
– The quality and control of the starting and raw
materials
– Some aspects of impurity control and testing that
are specific to the manufacturing of biological
medicines
– Analytical methods to assess the quality attributes
of the biologic.
– Impact on monographs and reference standards
modernization
SEPTEMBER 23-25 | TORONTO, ONTARIO - CANADA | SHERATON CENTRE TORONTO HOTEL

4. Session I: Process and Ancillary Materials
• Wednesday, September 23, 2009,
10:30 a.m. to 12:30 p.m.
– Ancillary Materials in Cell Manufacturing
Speakers: Anthony Ridgway/ Fouad Atouf
– Quality of reagents used in cell manufacturing
Speaker: Thomas Montague, BD Advanced
Bioprocessing
– Qualification of ancillary materials
Speaker: Robert Keem, Invitrogen
– Raw Material Testing
Speaker: Marina Kirkitadze, Sanofi Pasteur
SEPTEMBER 23-25 | TORONTO, ONTARIO - CANADA | SHERATON CENTRE TORONTO HOTEL

5. Session II: Residual DNA Testing
• Wednesday, September 23, 2009,
2:00 p.m. to 4:30 p.m.
– Assay approaches- Overview
Speaker: Wes Workman, Pfizer
– National Control Laboratory perspectives
Speaker: Junzhi Wang, NICPBP
– Reference material/ Metrology Lab perspective
Speaker: TBD, NIST
– Industry Perspective
Speaker: Seeven Vydelingum, Sanofi Pasteur
– Industry perspective
Speaker: Audrey Chang, ThermoFisher
SEPTEMBER 23-25 | TORONTO, ONTARIO - CANADA | SHERATON CENTRE TORONTO HOTEL

6. Session III: Monographs and Reference
Standards Modernization
• Thursday, September 24, 2009,
10:30 a.m. to 12:30 p.m.
– Heparin
Speaker: Wes Workman, USP Heparin Advisory Panel
– Glucagon
Speaker: Ann Jasperson, Novo Nordisk
– Pancrelipase
Speaker: Harold Rode, BB PP EC
– Insulins and HMW Insulin RS
Speaker: Matt Borer, Eli Lilly
SEPTEMBER 23-25 | TORONTO, ONTARIO - CANADA | SHERATON CENTRE TORONTO HOTEL

7. Session IV: Analytical Characterization
• Thursday, September 24, 2009
2:00 p.m. to 4:30 p.m.
– Sub-visible particulate analysis or aggregates
Speaker: Scott Aldrich
– Sub-Visible Particles
Speaker: Linda Nahri, Amgen
– Proteomics Approaches
Speaker: David Bunk, NIST
SEPTEMBER 23-25 | TORONTO, ONTARIO - CANADA | SHERATON CENTRE TORONTO HOTEL

8. Questions?
SEPTEMBER 23-25 | TORONTO, ONTARIO - CANADA | SHERATON CENTRE TORONTO HOTEL

9. Thank you!
SEPTEMBER 23-25 | TORONTO, ONTARIO - CANADA | SHERATON CENTRE TORONTO HOTEL