Keynote Presentation

Accelerating Development - Balancing Speed and Risk through a mProcess Trajectory
Thomas M. Spitznagel, Ph.D., Vice President, BioPharmaceutical Development, Human Genome Sciences, Inc.

Biosimilar Development: How will this Impact Early Process and Analytical Development?
Speaker TBA

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:

BMD Summit
Biopharmaceutical Manufacturing & Development
Achieving Speed and Cost Effectiveness in Today's Manufacturing Environment

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Are you working hard to structure your company's preclinical development programs to be efficient, cost-effective and fast, while meeting the IND requirements of regulatory agencies?

To do this successfully requires an in-depth knowledge of products and processes, coupled with sound organizational and scientific strategies. Preclinical Scale Bioprocessing, IBC's 8th early development forum, brings together scientists and team leaders working at this critical stage of development to exchange case studies and best practices dedicated to achieving these goals.

"This conference was able to cover many topics relating from early to late stage and tie the flow together in an informative way."
- Sandy McNorton, Senior Research & Development Scientist, SAFC Biosciences

Conference Highlights:

• Takeda San Francisco outlines the challenges of working with multiple CMOs on the early development of a complex antibody-drug conjugate.
• Neogenix assess the analytical comparability of two GMP lots of a therapeutic monoclonal antibody produced by two different manufacturing processes.
• Allergan shares its experience in the first time development of platformed analytical and process development approaches, and Immunogen breaks down the cost and time savings of an existing platform.
• Centocor discusses parallel processing and early development strategies that increase project success rates in preclinical development.
• Abbott describes the evolution of its preclinical/ clinical cell culture platform from hydrolysatebased to chemically-defined and how these changes impacted the project timeline.
• Biogen Idec explores its strategies for streamlining cell line screening and selection in early development.
• Merck analyzes a comparative study of process performance and quality for small scale single use bioreactor systems.
• Human Genome Sciences examines the challenges of fitting novel proteins into platformed downstream production processes.