Immunogenicity Session Spotlight: In-Vivo Optimization of the Performance of Monoclonal Antibodies

Each week leading up to the Immunogenicity event, we will spotlight a session that is critical to the industry.  Today, we look at the special keynote speech from Dr. Amy Rosenberg – Director of the Division of Therapeutic Proteins at FDA.  She will address the how molecular safety can be greatly improved by focusing less on in-vitro projections and more on actual in-vivo performance. The ultimate fate of biomolecules in living systems is not sufficiently understood, and learning more in this realm will be critical to improving biologic performance.

Immunogenicity for Biotherapeutics will take place March 18-20, 2013 in Baltimore, Maryland.  For more information on this program, download the agenda.  If you'd like to join us, register today and mention code XP1838BLOG to save 15% off the standard rate.

Rosenberg

Featured Session: In-Vivo Optimization of the Performance of Monoclonal Antibodies

Featured Speaker: Amy Rosenberg, Director, Division of Therapeutic Proteins, FDA

About the session: The industry’s historic focus on in-vitro analysis of new therapeutics has not been conducive towards the design and selection of the best molecular candidates possible. The “next frontier” of molecular research will be based upon a better understanding of the ultimate fate of monoclonal antibodies in-vivo. This new focus allows for more reliable development of safer biomolecules and proves to be particularly critical for the advancement of biobetters.

• • Understanding and compensating for the links between protein aggregation in-vivo, deamidation and autoimmune disorders
• • Accounting for the role of pH on in-vivo therapeutic protein performance
• • Improved techniques for tracking the fate of therapeutic proteins

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