| This workshop covers the technical considerations in the design, development, validation, and interpretation of neutralizing antibody assays, including:
• Design & Development of Neutralizing Antibody Assays:
- Selection of assay platform – ligand-binding versus bioassay?
- Sensitivity – how to determine the sensitivity of the assay and how sensitive does it need to be?
- Selection and number of reference standards and to controls?
- Cutpoints – fixed, variable, or "other"
- Matrix effects
- Drug interference issues:
• How much residual drug should the assay tolerate?
• How to design a drug tolerant assay?
• Interpretation:
- Guidelines used while reporting the data- Titers, Cut-offs, or EC50
- How much neutralizing antibodies are needed to compromise efficacy? How do you determine that?
- How do you deal with inconclusive IR data when drug is still in circulation
• Neutralizing Ab+ Cell-based assays
Neutralizing Antibody Assays for Naked Antibody and Antibody Drug Conjugate Products
• Assay format & detection systems
• Cut point determination for Neutralizing Antibody Assays
• Selection of Negative and Positive Controls
• Product interference
• Evaluation of assay parameters
Workshop Leaders:
Shalini Gupta, PhD, Associate Director Clinical Immunology,
AMGEN
An Song, Scientist,
GENENTECH
Uma Prabhakar, PhD, Director, Clinical Pharmacology & Experimental Medicine,
CENTOCOR
Wolf Klump, PhD, Principal Scientist, Analytical Biochemistry and Formulation,
SEATTLE GENETICS
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