Clinical Immunogenicity Risk Assessment Strategy for a Low Risk Monoclonal Antibody
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmaceutical Science
Link
http://link.springer.com/content/pdf/10.1208/s12248-020-00440-5.pdf
Reference61 articles.
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2. Shankar G, Pendley C, Stein KE. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat Biotechnol. 2007;25(5):555–61.
3. Strand V, Balsa A, Al-Saleh J, Barile-Fabris L, Horiuchi T, Takeuchi T, et al. Immunogenicity of biologics in chronic inflammatory diseases: a systematic review. BioDrugs. 2017;31(4):299–316.
4. Nelson AL, Dhimolea E, Reichert JM. Development trends for human monoclonal antibody therapeutics. Nat Rev Drug Discov. 2010;9(10):767–74.
5. Araujo J, Zocher M, Wallace K, Peng K, Fischer SK. Increased rheumatoid factor interference observed during immunogenicity assessment of an fc-engineered therapeutic antibody. J Pharm Biomed Anal. 2011;55(5):1041–9.
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