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Single-Use Applications for Biopharmaceutical Manufacturing

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Novel Data from End-Users and Opportunities for Time and Cost Savings

June 14 - 16, 2010 · Hyatt Regency La Jolla · San Diego, CA

Document Title

Agenda at a Glance

Agenda at a Glance

Agenda at a Glance

Your registration gives you access to both conferences

  Single-Use Applications for Biopharmaceutical Manufacturing Vaccine Production Summit
Monday
Morning

Pre-Conference Workshop: Lessons Learned from the Cutting Edge of Disposable Implementation

Pre-Conference Workshop: Implementing New Technologies and Process Validation Guidelines for Vaccine Production

Monday
Afternoon

Keynote Presentation:
Optimizing Biomanufacturing Architectures
R. Barry Holtz, Ph.D., President, G-Con, LLC

Featured Presentation:
Review of Single Use Processes
LCDR Destry Sillivan, USPHS, CBER, FDA

Sessions:
Qualification and Validation: Assessing Risk Factors
Disposal of Disposables

Keynote Presentation:
Improving Interactions between the FDA, Regulated Industry, and Academia
Matthew Stober, Novartis Vaccines & Diagnostics

Sessions:
Next Generation Expression Systems for Increased Yield and Quality
Novel Vaccine Purification Methods

Tuesday
Morning

Session:
Disposable Sensors, Probes and Bioreactor Implementation

Keynote Presentation:
Using Next Generation Production Methods to Add Vaccine Production Capacity in Developing Countries
George A. Robertson, Ph.D., PATH

Special Presentation:
DARPA Accelerated Manufacture of Pharmaceuticals (AMP) Program
Michael V. Callahan, M.D.,Defense Advanced Research Projects Agency (DARPA)

Session:
Process Development for New Classes of Immunotherapies

Tuesday
Afternoon

Shared Session: Single Use Systems for Vaccine Production

Keynote Presentation: The Universal Applicability of Single Use Technologies for Virtually All Types of Vaccine Production
Parrish M. Galliher, Xcellerex, Inc.

Audience Interactive Panel Discussion: World's First Fully Disposable Process Train for Vaccine Manufacturing

Wednesday
Morning

Session:
Latest Disposable Technologies in Downstream Processing

Sessions:
Production of Conjugate and Multi-Component Vaccines
Scale-Up and Technology Transfer

Wednesday
Afternoon

Single Use conference ends at noon, and delegates are welcome to attend afternoon sessions of Vaccine Production Summit.

Sessions:
Vaccine Formulation, Stability and Delivery
Analytical Characterization and Release Specifications

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