2012 - Strategic Selection and Development of Immunogenicity Binding Methods

This 90-minute webinar will show how to select the best technology and format combination to develop a compliant immunogenicity binding method, and provide a check-list that itemizes all the requirements to develop a compliant validation protocol.
Why Should You Attend:
The principal components of a meaningful immunogenicity program consist of an initial binding screen followed by confirmation and quantitation of the positive samples.
This 90-minute webinar first reviews the technologies and formats currently in use to detect unwanted immunogenicity.
Areas Covered in the Seminar:
- Regulatory expectations
- Technology platforms: Label dependent and label independent Feasibility and timeline
- Assay formats: Bridging and direct
- Controls and reagents: Preparation, storage and stability
- Feasibility Storage of cell banks to certify stability
- Optimization: MFAT/DOE versus OFAT
- Pre-validation
- Check-list for validation