Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

Journal of Immunological Methods

Volumn 289, Issue 1-2, 2004, Pages 1-16

  Mire Sluis, Anthony R ^a   Barrett, Yu Chen ^b   Devanarayan, Viswanath ^c   Koren, Eugene ^d   Liu, Hank ^e   Maia, Mauricio ^f   Parish, Thomas ^g   Scott, George ^h   Shankar, Gopi ⁱ   Shores, Elizabeth ^a   Swanson, Steven J ^d   Taniguchi, Gary ^j,l   Wierda, Daniel ^c   Zuckerman, Linda A ^k  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d AMGEN INC   (United States)

^e PFIZER INC   (United States)

^f PDL Inc   (United States)

^g Proctor and Gamble Pharmaceuticals   (United States)

^h MDS Inc   (Canada)

ⁱ CENTOCOR INC   (United States)

^j BIOMARIN PHARMACEUTICAL INC   (United States)

^k ZYMOGENETICS INC   (United States)

^l GENENTECH INC   (United States)

more..

Author keywords

Antibody; Assays; Immunogenicity

Indexed keywords

IMMUNOGLOBULIN F(AB) FRAGMENT; IMMUNOGLOBULIN FC FRAGMENT; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; IODINE 125; MONOCLONAL ANTIBODY;

ACCURACY; ANTIBODY AFFINITY; ANTIBODY DETECTION; ANTIBODY RESPONSE; ANTIBODY SCREENING; ANTIBODY TITER; BIOTECHNOLOGY; CHEMOLUMINESCENCE; DILUTION; ENZYME LINKED IMMUNOSORBENT ASSAY; HALF LIFE TIME; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH THROUGHPUT SCREENING; HUMAN; IMMUNOASSAY; IMMUNOBLOTTING; IMMUNOGENICITY; IMMUNOPRECIPITATION; ISOTOPE LABELING; OPTICAL DENSITY; PRIORITY JOURNAL; QUALITY CONTROL; RADIOACTIVITY; RADIOISOTOPE DECAY; REVIEW; SENSITIVITY ANALYSIS; STATISTICAL SIGNIFICANCE; SURFACE PLASMON RESONANCE;

EID: 3142534409     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jim.2004.06.002     Document Type: Article

References (6)

1. Finney D.J. Statistical Method in Biological Assay. 3rd edn. 1978;Charles Griffin, London
2. Findlay J.W.A., et al. Validation of immunoassays for bioanalysis: A pharmaceutical industry perspective. Journal of Pharmaceutical and Biomedical Analysis. 21:2000;1249-1273
3. International Committee for Harmonization. Q2A: Text on Validation of Analytical Procedures. Available at http://www.fda.gov/cder/guidance/index.htm
4. International Committee for Harmonization. Q2B: Validation of Analytical Procedures: Methodology. Available at http://www.fda.gov/cder/guidance/index.htm
5. Lee J.W., Smith W.C., Nordblom G.D., Bowsher R.R. Validation of assays for the bioanalysis of novel biomarkers. Bloom J.C., Dean R.A. Biomarkers in Clinical Drug Development. 2003;119-149 Marcel Dekker
6. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for Industry: Bioanalytical Method Validation (May 2001). Available at http://www.fda.gov/cder/guidance/index.htm