SOURCE: IBC Life Sciences

January 30, 2006 09:00 ET

IBC'S Early Development of Biotherapeutics Event Presents Case Studies From Medarex, Chiron, Genentech, Centecor and More

WESTBOROUGH, MA -- (MARKET WIRE) -- January 30, 2006 -- IBC's 3rd Early Development of Biotherapeutics event to be held May 15-17, 2006 at the La Costa Spa and Resort in Carlsbad, CA, will feature Medarex, Chiron and Genentech presenting case studies of how companies of different sizes approach the timelines and transitions of early development; Centocor is presenting a case study of leachables and their impact on the immunogenicity of EPREX® ; and Chiron and the Abbott Bioresearch Center will show how candidate selection and process development can be improved through early development of analytical support.

Helene Gazzano-Santoro, Ph.D., Scientist and Group Leader for Quality Control at Genentech, will cover Challenges in the Selection, Transfer and Monitoring of Potency Assays for Lot Release. This will be part of half a day of programming on Biological Assays & Development. Early Development of Biotherapeutics attendees and Biological Assay Development & Validation attendees will share a day of sessions featuring 3 case studies, breaks, a luncheon, and a cocktail reception, creating a rare opportunity to share perspectives and strategies with hundreds of leaders in the industry.

Other highlights will include:

--  How to overcome design and formulation issues for high concentration
--  The pros and cons of different ways of structuring the timelines and
    transitions in early development -- presented from the perspective of
    small, medium and large research organizations
--  Methods for early profiling of the pharmacokinetic behavior of a
    molecule and the use of this information to guide bioanalytical method
    development and validation
--  Non-mammalian expression systems -- current alternatives and methods
    you can use to analyze and select the best system for your application
--  Case studies of analytical challenges related to novel formulations
    and delivery systems -- information you need to support your company’s
    product differentiation efforts
--  Approaches to balancing the time and expense pressures of early
    process development with downstream scale-up considerations

Attendees will gain the ability to improve the quality and pace of their early development programs by understanding the current industry and regulatory approaches to preclinical, clinical and product development of biotherapeutics.

ATTENTION CALENDAR EDITORS! For more information on attending Early Development of Biotherapeutics at the La Costa Resort and Spa in Carlsbad, CA, visit

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