Author:
Wu Yuling,Akhgar Ahmad,Li Jia J,Yu Binbing,Chen Cecil,Lee Nancy,White Wendy I.,Roskos Lorin K.
Publisher
Springer Science and Business Media LLC
Reference15 articles.
1. Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods. 2008;333:1–9.
2. Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-Dupont P, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med. 2002;346:469–75.
3. U.S. Pharmacopeal Convention. Immunogenicity assays-design and validation of assays to detect anti-drug neutralizing antibody. 2014.
http://www.uspnf.com
/ Accessed 11 July 2017,
4. U.S. Department of Health and Human Services. Food and Drug Administration. Guidance for industry. Assay development for immunogenicity testing of therapeutic proteins. Draft guidance (2009). July 11, 2017. Available from:
https://www.regulations.gov/contentStreamer?documentId=FDA-2009-D-0539-0002&attachmentNumber=1&contentType=pdf
5. Finco D, Baltrukonis D, Clements-Egan A, Delaria K, Gunn GR III, Lowe J, et al. Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics. J Pharm Biomed Anal. 2011;54:351–8.
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