Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics-Reference-Cited by-同舟云学术

Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics

Published:2011-07 Issue:5 Volume:55 Page:878-888
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Gupta Shalini,Devanarayan Viswanath,Finco Deborah,Gunn George R.,Kirshner Susan,Richards Susan,Rup Bonita,Song An,Subramanyam Meena

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference19 articles.

1. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics;Gupta;J. Immunol. Methods,2007

2. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs;Shankar;Nature Biotechnol.,2007

3. Pharmacokinetics and antibody responses to the CD 3 antibody otelixizumab used in the treatment of type 1 diabetes;Hale;J. Clin. Pharmacol.,2010

4. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products;Mire-Sluis;J. Immunol. Methods,2004

5. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products;Koren;J. Immunol. Methods,2008

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