Current Considerations on Characterization of Immune Response to Multi-Domain Biotherapeutics

Author:

Gorovits BorisORCID,Peng Kun,Kromminga Arno

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Reference93 articles.

1. Shankar G, Shores E, Wagner C, Mire-Sluis A. Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol. 2006;24(6):274–80.

2. 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(1–2):1–9.

3. Gorovits B, Wakshull E, Pillutla R, Xu Y, Manning MS, Goyal J. Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics. J Immunol Methods. 2014;408:1–12.

4. FDA. Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection. Guidance for Industry: U.S. Department of Health and Human Services Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER); 2019. https://www.fda.gov/media/119788/download . Accessed 17 Oct 2019.

5. Rosenberg AS. Immunogenicity of biological therapeutics: a hierarchy of concerns. Dev Biol. 2003;112:15–21.

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