Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics
The administration of biological therapeutics can evoke some level of immune response to the drug product in the receiving subjects. An immune response comprised of neutralizing antibodies can lead to loss of efficacy or potentially more serious clinical sequelae. Therefore, it is important to monit...
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| Published in | Journal of immunological methods Vol. 321; no. 1; pp. 1 - 18 |
|---|---|
| Main Authors | , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Amsterdam
Elsevier B.V
10.04.2007
Elsevier |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0022-1759 1872-7905 |
| DOI | 10.1016/j.jim.2006.12.004 |
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| Abstract | The administration of biological therapeutics can evoke some level of immune response to the drug product in the receiving subjects. An immune response comprised of neutralizing antibodies can lead to loss of efficacy or potentially more serious clinical sequelae. Therefore, it is important to monitor the immunogenicity of biological therapeutics throughout the drug product development cycle. Immunoassays are typically used to screen for the presence and development of anti-drug product antibodies. However, in-vitro cell-based assays prove extremely useful for the characterization of immunoassay-positive samples to determine if the detected antibodies have neutralizing properties. This document provides scientific recommendations based on the experience of the authors for the development of cell-based assays for the detection of neutralizing antibodies in non-clinical and clinical studies. |
|---|---|
| AbstractList | The administration of biological therapeutics can evoke some level of immune response to the drug product in the receiving subjects. An immune response comprised of neutralizing antibodies can lead to loss of efficacy or potentially more serious clinical sequelae. Therefore, it is important to monitor the immunogenicity of biological therapeutics throughout the drug product development cycle. Immunoassays are typically used to screen for the presence and development of anti-drug product antibodies. However, in-vitro cell-based assays prove extremely useful for the characterization of immunoassay-positive samples to determine if the detected antibodies have neutralizing properties. This document provides scientific recommendations based on the experience of the authors for the development of cell-based assays for the detection of neutralizing antibodies in non-clinical and clinical studies.The administration of biological therapeutics can evoke some level of immune response to the drug product in the receiving subjects. An immune response comprised of neutralizing antibodies can lead to loss of efficacy or potentially more serious clinical sequelae. Therefore, it is important to monitor the immunogenicity of biological therapeutics throughout the drug product development cycle. Immunoassays are typically used to screen for the presence and development of anti-drug product antibodies. However, in-vitro cell-based assays prove extremely useful for the characterization of immunoassay-positive samples to determine if the detected antibodies have neutralizing properties. This document provides scientific recommendations based on the experience of the authors for the development of cell-based assays for the detection of neutralizing antibodies in non-clinical and clinical studies. The administration of biological therapeutics can evoke some level of immune response to the drug product in the receiving subjects. An immune response comprised of neutralizing antibodies can lead to loss of efficacy or potentially more serious clinical sequelae. Therefore, it is important to monitor the immunogenicity of biological therapeutics throughout the drug product development cycle. Immunoassays are typically used to screen for the presence and development of anti-drug product antibodies. However, in-vitro cell-based assays prove extremely useful for the characterization of immunoassay-positive samples to determine if the detected antibodies have neutralizing properties. This document provides scientific recommendations based on the experience of the authors for the development of cell-based assays for the detection of neutralizing antibodies in non-clinical and clinical studies. |
| Author | Gupta, Shalini Mire-Sluis, Anthony R. Richards, Susan M. Swanson, Steven J. Jethwa, Vijay Rup, Bonita Kelley, Marian Shores, Elizabeth Wakshull, Eric Indelicato, Stephen R. Kawabata, Thomas |
| Author_xml | – sequence: 1 givenname: Shalini surname: Gupta fullname: Gupta, Shalini email: shalinig@amgen.com organization: Clinical Immunology, Amgen Inc., Thousand Oaks, CA 91320, USA – sequence: 2 givenname: Stephen R. surname: Indelicato fullname: Indelicato, Stephen R. organization: PharmSci Quality-Quality Systems Improvement Office, Schering Plough Research Institute, Kenilworth, NJ, 07033, USA – sequence: 3 givenname: Vijay surname: Jethwa fullname: Jethwa, Vijay organization: Bioanalytical QC RTP, Biogen Idec, Research Triangle Park, NC 27709, USA – sequence: 4 givenname: Thomas surname: Kawabata fullname: Kawabata, Thomas organization: Safety Sciences, Pfizer Global Research and Development, Groton, CT 06340, USA – sequence: 5 givenname: Marian surname: Kelley fullname: Kelley, Marian organization: Clinical Pharmacology & Experimental Medicine, Centocor R&D Inc., Radnor, PA 19087, USA – sequence: 6 givenname: Anthony R. surname: Mire-Sluis fullname: Mire-Sluis, Anthony R. organization: Corporate Operations, Amgen Inc., Thousand Oaks, CA 91320, USA – sequence: 7 givenname: Susan M. surname: Richards fullname: Richards, Susan M. organization: Immunology, Cell & Protein Therapeutics R&D, Genzyme Corp. Framingham, MA 01701, USA – sequence: 8 givenname: Bonita surname: Rup fullname: Rup, Bonita organization: Bioanalytical R&D, Wyeth Research, Andover, MA 01810, USA – sequence: 9 givenname: Elizabeth surname: Shores fullname: Shores, Elizabeth organization: Division of Therapeutic Protein, Office of Biotechnology Product, Center for Drug Evaluation and Research, FDA, MD 20892, USA – sequence: 10 givenname: Steven J. surname: Swanson fullname: Swanson, Steven J. organization: Clinical Immunology, Amgen Inc., Thousand Oaks, CA 91320, USA – sequence: 11 givenname: Eric surname: Wakshull fullname: Wakshull, Eric organization: Clinical Science & Technology, Biogen Idec, Cambridge, MA 02142, USA |
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| Keywords | EPO PRCA SPA Immunogenicity assay mRNA FACS MTT TNF NAb MAb GFP HSA Cell-based assay EIA Neutralizing antibody bioassay IL-1 RIA KIRA ECL rHuEPO Serum-based bioassay CV CAT MGDF NAb assay BrdU Ig ELISA Bioassay Immune response Neutralizing antibody Optimization Immunological method Biological compound Immunogenicity Serum Detection Humoral immunity |
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| Title | Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics |
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