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. These sections will help the scientist to a priori select the appropriate procedures to specifically meet the needs of their product. The second part of the webinar provides a step by step approach to develop a method that will meet the current validation standards regardless of the technology and format that is utilized. Case studies are cited throughout the webinar to demonstrate the impact of the method on immunogenicity results. Finally, a check-list is supplied to ensure that essential requirements are in place to proceed into validation.
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
- Check-list for validation