Several workshops have been organized to discuss the immunogenicity issues. Regulatory agencies are developing the guidelines to give industry the directions to incorporate the immunogenicity testing into the clinical development program for biological products.
Since the immunogenicity testing relies on the assay to measure the immune responses, the results of immunogenicity depend on which assay is used for testing. Therefore, the development of immunogenicity assay is also a critical issue in immunogenicity testing. Using an ultra sensitive assay could detect many false positives in immunogenicity testing. Using a less sensitive assay could under-estimate the immune response.
The following collection regarding immunogenicity testing should provide a good resource for this topic.
- EMEA's Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
- A European Perspective on Immunogenicity Evaluation. Nature Biotechnology
- EMEA's Concept Paper on Immunogenicity Assessment of Monoclonal Antibodies Intended for In Vivo Clinical Use
- EMA: Immunogenicity Assessment of Monoclonal Antibodies Intended for In-vivo Clinical Use (2012)
- EMEA's Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
- EMEA's Concept Paper on Guideline on Immunogenicity Assessment of Therapeutic Proteins
- Presentaton on 'EMEA guidance on immunogenicity for biologicals' by Dr. Robin Thorpe
- FDA's Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins
- FDA Guidance: Immunogenicity Assessment for Therapeutic Protein Products
- Immunogenicity of Protein-based Therapeutics
- The immunogenicity of therapeutic proteins- what you don’t know can hurt YOU and the patient
- FDA/DIA Scientific Workshop on Follow-on Protein Pharmaceutials
- EMEA Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: one-clinical and clinical issues
- EMEA's Guideline on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as active substance: non-clinical and clinical issues
No comments:
Post a Comment