Strategy and Validation of a Nonclinical Generic Plug-and-Play Antidrug Antibody Method for Human Monoclonal Antibody Biotherapeutics
Author:
Affiliation:
1. GSK, Immunogenicity Group, Collegeville, PA 19426, USA
Publisher
Informa UK Limited
Link
https://www.tandfonline.com/doi/pdf/10.4155/bio-2023-0184
Reference32 articles.
1. International Conference on Harmonisation; addendum to International Conference on Harmonisation Guidance on S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; availability;US Food and Drug Administration;Notice. Fed Regist.,2012
2. European Medicines Agency . Guideline on Immunogenicity assessment of therapeutic proteins. 1–24 (2017).
3. US Food and Drug Administration . Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection. 1–33 (2019).
4. Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies
5. Immunogenicity and other problems associated with the use of biopharmaceuticals
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