Keynotes Presentations

Deploying Business Process Excellence in Biologics Manufacturing
James R. Kasselmann, Director, Clinical Manufacturing, Genentech, Inc.

Next Generation Process in a New Biotechnological Facility
Kim Sandell, Director, Operations Management & Operational Excellence, Pfizer, Sweden

Facility of the Year Award: Operational Excellence

Amgen's Perspective on Manufacturing of the Future
Stephen J. Hill, Executive Director Manufacturing Technology, Amgen

Special Discounted Hotel Rate

Special Discounted Hotel Rate Available Until Friday, August 19, 2011.
To book your room, call 619-297-5466 and mention that you are an IBC attendee at this event.

Free Access to Co-Located Event:

IBC's 8th AnnualEarly Development Forum
Preclinical Scale Bioprocessing
A Best Practices Exchange for R&D to IND Stage Biologics Development

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Are you or your team responsible for ensuring the efficiency, supply chain security, consistency, safety, and uninterrupted supply of your company's product?

Do you need to ensure that your facility and processes are optimized to accommodate today's best technologies as well as tomorrow's products?

Plan now to attend the only event that focuses on implementation strategies that will help you plan for the integration of single-use technologies and other flexible manufacturing schemes.

The BMD Summit brings you up-to-the-minute reports from industry leaders who will help you ensure quality, safety, competitiveness and an uninterrupted supply of safe products to patients.

"Greatly facilitates keeping informed of current key biotech practices, learnings, and players/SMEs."
- Stacey M. Kaneshiro, Senior Consultant Engineer, Eli Lilly and Co.

Enabling Flexible Facilities

Accommodate your changing product and process needs with:

• Alternatives to Protein A
• Risk-Based Decisions for Multi-Product Facilities
• Manufacturing Platforms Used for Biosimilars
• Large Scale Integration of Disposables
• Novel Downstream Technologies

Biomanufacturing Excellence

Ensure your products' quality, safety and competitiveness with:

• Continuous, Disposable Antibody Purification
• Process Adaptations for Increased Robustness and Risk Mitigation
• Strategies for the Development and Manufacturing of Biosimilars
• Supply Chain Risk Mitigation
• Risk Management Approaches to Process Design and Technology Transfer

In-Depth Symposium:

Assessing and Preventing the Risk of Using Disposables

• Managing Supplier Relationships including Raw Material Changes
• Process Validation for Extractables and Leachables

"This will be a great opportunity to learn what other specialists are doing in the disposables for biotech arena."
- James W. Chrostowski, Ph.D., Engineer III, Biogen Idec

Special Feature:
Keynotes and plenary presentations on two ISPE-awarded facilities of the year from Pfizer and Shire, Genentech's business process excellence strategy to receive "Class A" certification, and Amgen's perspective on future plans for more cost-effective manufacturing.