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USP Annual Science Meeting - Biologics Track Preview!
USP Annual Science Meeting - Biologics Track Preview!
USP Annual Science Meeting - Biologics Track Preview!
USP Annual Science Meeting - Biologics Track Preview!
USP Annual Science Meeting - Biologics Track Preview!
USP Annual Science Meeting - Biologics Track Preview!
USP Annual Science Meeting - Biologics Track Preview!
USP Annual Science Meeting - Biologics Track Preview!
USP Annual Science Meeting - Biologics Track Preview!
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USP Annual Science Meeting - Biologics Track Preview!

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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 …

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

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  • 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

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