Symposium #1: Contamination Control - Lessons Learned, Best Practices and Case Studies

Symposium #2: Incorporating Single-Use in Process Development and Scale Up

Symposium #4: Global Strategies and Experience in the Development of Biosimilars

Symposium #5: Case Studies of Process and Analytical Transfers in Biomanufacturing

Symposium #6: Using DOE Effectively for Process Characterization without Getting Lost in the Statistics

Managing Global Manufacturing and Development Assets including Internal and Partners' Facilities

Process Design for Lifecycle Management

Analytical Technologies for Biopharmaceutical Development

Keynote Presentation: Understanding How Solution Conditions Affect Stability by Investigating Site Specific Changes within Proteins
(8:00 am - 8:45 am)

Monitoring and Improving Formulation Stability
(8:45 am - 9:45 am)

Managing Global Manufacturing and Development Assets including Internal and Partners' Facilities (continued)

Process Design for Lifecycle Management (continued)

Analytical Technologies for Biopharmaceutical Development

Monitoring and Improving Formulation Stability (continued)

Integrating New Technologies Sponsored by Cook Pharmica

Technology Workshops Sponsored by: 3M Purification, BD Biosciences, Rentschler Biotechnologie, and SAFC

Luncheon Presentation Sponsored by: EMD Millipore (space is limited)

Managing Supplier Relationships to Drive Competitive Advantage

Implementation and Execution of Lifecycle Management Strategies

Characterization and Control of Subvisible Particles

Global Advances in the Development and Regulation of Biosimilars
(1:30 pm - 4:00 pm)

Keynote Presentations: Overview of Approval Pathway under Biologics Price Competition and Innovation Act of 2009 EMA Draft Guideline on Biosimilar Monoclonal Antibodies Ready or not Biosimilars are Coming to U.S.

Formulation Development for High Concentration Protein Therapeutics

Technology Workshop Sponsored by: Xcellerex

Achieving Rapid Process Development and Novel Technology Implementation

Continuous Process Improvements for Lifecycle Management

Novel Approaches and Applications for Viral Clearance

Formulation Impacts for Biosimilar Development

Achieving Rapid Process Development and Novel Technology Implementation (continued)

Continuous Process Improvements for Lifecycle Management (continued)

Novel Approaches and Applications for Viral Clearance

Design Space and Quality by Design

The Future of Single Use Technology Sponsored by ThermoScientific

Technology Workshops Sponsored by: Bio-Rad Laboratories, Irvine Scientific, Life Technologies, and Novasep

Formulation for Lyophilized Products

Disposables in Cell Culture

Case Studies: Resolving Formulation Problems

Technology Workshop Sponsored by: GE Healthcare

Keynote Presentation: The International Chinese Hamster Ovary Genome Project: Where Do We Go from Here?

Streamlining Downstream Processing to Improve Cost and Time to Clinic

Keynote Presentations:

Vac to the Future: Vaccines Bioprocessing and Development

Public-Private Partnering for National Security & Public Health Needs

Impact of Packaging and Delivery Devices on Formulation Development

Systems Biology Approaches to Cell Culture Development

Vaccine Development & Production

Novel Approaches to Cell Line Development

Streamlining Downstream Processing to Improve Cost and Time to Clinic (continued)

Vaccine Development & Production

Process and Manufacturing Issues in Formulation Development

Featured Presentation: Fitting the Glass Slipper - Process Design, Plant Capacity and Value Realization
(11:30 am - 12:00 pm )

Flexibility and Agility as Strategic Purpose, Time and Cost Savers as a Tactical Means to Get There

Technology Workshops Sponsored by: Life Technologies, Natrix Separations, Sartorius Stedim Biotech and Sheffield Biosciences

Advances in Media and Feed Design

Advances in Initial Recovery - Viewing the Harvest Step as a Purification Step

Vaccine Development & Production

Analytical Studies to Support Formulation Development

Business Models for Biotech-CMO Partnerships Sponsored by DSM (1:45 pm - 3:15 pm)

Innovative Principles and Integration in Upstream and Downstream Processing

Vaccine Development & Production

3:15 pm Close of Formulation Conference

Featured Presentation: The Impact of Antibody Drug Conjugates on Process Development and Manufacturing

Technology Workshop Sponsored by: SAFC (opportunities still available)

Accelerating and Optimizing Process Development and Production

Overcoming the Bottlenecks in Downstream Processing

Beyond Antibodies - Cell Culture Process Development of Novel Molecules and Next Generation Therapeutics

Use of Monitoring and High-Throughput Methods in Downstream Process Development

The Industrialization of Single-Use Manufacturing Technology Sponsored by ATMI, EMD Millipore, Pall Life Sciences, and Sartorius-Stedim Biotech

Technology Workshop Sponsored by: Applikon/Aber Instruments, GE Healthcare and Sanofi

Improving Predictability in Early Development

Beyond Antibodies - Downstream Processing of Next Generation and Novel Molecules

Improving and Controlling Product Quality

Process Validation and Characterization