Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development-Reference-Cited by-同舟云学术

Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development

Published:2017-11 Issue:6 Volume:19 Page:1576-1586
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Xue Li,Clements-Egan Adrienne,Amaravadi Lakshmi,Birchler Mary,Gorovits Boris,Liang Meina,Myler Heather,Purushothama Shobha,Manning Marta Starcevic,Sung Crystal

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/article/10.1208/s12248-017-0153-x/fulltext.html

Reference58 articles.

1. Turano A, et al. Natural human antibodies to gamma interferon interfere with the immunomodulating activity of the lymphokine. Proc Natl Acad Sci U S A. 1992;89(10):4447–51.

2. Caruso A, Turano A. Natural antibodies to interferon-gamma. Biotherapy. 1997;10(1):29–37.

3. Xue L, et al. Pre-existing biotherapeutic-reactive antibodies: survey results within the American Association of Pharmaceutical Scientists. AAPS J. 2013;15(3):852–5.

4. Bendtzen K. Autoantibodies to cytokines. Eur J Clin Investig. 1998;28(4):300–1.

5. Soos JM, et al. Identification of natural antibodies to interleukin-18 in the sera of normal humans and three nonhuman primate species. Clin Immunol. 2003;109(2):188–96.

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