Immunogenicity Testing for Protein-based Therapeutics

Venue: Boston

Location: Boston, Massachusetts, United States

Event Date/Time: Sep 23, 2002 End Date/Time: Sep 24, 2002
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With the rapid growth in the market for biotherapeutics, the pharmaceutical and biotechnology industries have seen a tremendous increase in antibody and protein-based therapeutics in the pipeline. Worldwide sales of therapeutic proteins made using recombinant DNA technology were approximately $17 billion in

1999 and are projected to have annual sales growth rate of 10 to 15% (according to Maxygen, Inc., Redwood City, CA, October 2001). In addition, antibody-based therapeutic sales are estimated to grow by over 550% between 1999 and 2005 (Therapeutic Protein 2000: Key Markets and Future Strategies – Datamonitor, October 2001).

A key consideration in development of protein-based therapeutics is identifying and characterizing any immune response to treatment. The administration of an antibody or protein into a human host can, in some cases, trigger immunogenicity, which can reduce the efficacy of a potentially therapeutic protein, can likely compromise its safety and result in altered pharmacokinetics, all of which may serve as a barrier to further development. Because of such potential consequences, there is a need to develop methods to predict whether a protein will be immunogenic prior to administration in the clinic.

Recognizing these potential hazards, The Institute for International Research is proud to present the Immunogenicity Testing for Protein-based Therapeutics conference. The goal of this conference is to explore various strategies for preventing immunogenicity and for predicting it earlier in the process. This conference is designed to:

Highlight some of the methods available for improved antibody detection and characterization
Discuss strategies currently utilized to assess the quality of final therapeutic proteins
Clarify validation parameters for immunogenicity assays
Determine how to measure immunogenicity and determine the level of intensity
More specifically, sessions allow delegates to:

Hear a case study addressing immunogenicity concerns for recombinant factor VIII
Review FDA filings in a case study of an anti-hemophilia drug
Illustrate how assays impact on the design of immunogenicity studies
Examine the characteristics of a good neutralizing antibody assay
Discuss the incidents of immunogenicity that commonly occur
Determine novel techniques for measuring immunogenicity
Resolve technical and regulatory issues in the development of immunoassays used in immunogenicity testing
Featured Presentations

Abby Celniker, PhD of Millennium Pharmaceuticals addresses the need for immunogenicity testing and the FDA’s concerns.

Anthony Mire-Sluis, PhD of Cancervax Corporation outlines the regulatory guidelines from the initial design of the immunogenicity studies and throughout the assay process.

Stephen Indelicato, PhD of Schering-Plough Pharmaceuticals describes the characteristics of a useful neutralizing antibody assay and provide suggestions for the direction to be taken to produce a standardized assay.

Mauricio Maia, PhD of Protein Design Labs examines the implications of testing for immunogenicity in drug-positive samples.

Steven Swanson, PhD of Amgen reviewes novel technologies for measuring immunogenicity.

Don Baker, PhD of Baxter Bioscience shares a case study addressing immunogenicity concerns in the factor VIII molecule.

About our Pre-conference Workshop
Demonstration of Comparability of Biological Products during DevelopmentDelegates discuss the most recent developments concerning comparability protocols, specifications, immunogenicity, scale-up and post-approval changes, and the use of biological assays. Delegates will also document the use of comparability protocols and studies in securing global approvals and effecting manufacturing changes.

Learn from leading industry experts and take advantage of this key opportunity to network with industry colleagues. As a delegate at Immunogenicity Testing for Protein-based Therapeutics, you also receive a complete set of program documentation, a valuable reference tool for your office.

Register today! Space is limited.