Stability studies of binding and functional anti-vaccine antibodies

Bioanalysis

Volumn 6, Issue 10, 2014, Pages 1385-1393

  Hendriks, Jenny ^a   Stals, Coby ^a   Versteilen, Amanda ^a   Mommaas, Bregje ^a   Verhoeven, Mariëlle ^a   Tirion, Felicia ^a   Haak, Mariskater T ^a   Ribbens, Wolf ^a   Bosch, Marije ^a   Trommel, Martijn ^a   Kostense, Stefan ^a  

^a CRUCELL HOLLAND BV   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN G; IMMUNOGLOBULIN G ANTIBODY; MALARIA VACCINE; NEUTRALIZING ANTIBODY; POLYCLONAL ANTIBODY; CIRCUMSPOROZOITE PROTEIN, PROTOZOAN; PROTOZOAL PROTEIN; VACCINE;

ANTIBODY BLOOD LEVEL; ARTICLE; BIOASSAY; DRUG BINDING; DRUG STABILITY; DRUG STORAGE; ENZYME LINKED IMMUNOSORBENT ASSAY; FREEZE THAWING; HEAT INACTIVATION; HEPATITIS A VIRUS; HEPATITIS B VIRUS; IMMUNOGENICITY; PHARMACOLOGICAL PARAMETERS; PRACTICE GUIDELINE; ROOM TEMPERATURE; TEMPERATURE SENSITIVITY; ADENOVIRIDAE; BLOOD; FREEZING; HUMAN; IMMUNOLOGY; PROTEIN STABILITY; REGRESSION ANALYSIS; TEMPERATURE; TIME;

ADENOVIRIDAE; ANTIBODIES, NEUTRALIZING; ENZYME-LINKED IMMUNOSORBENT ASSAY; FREEZING; HEPATITIS A VIRUS; HEPATITIS B VIRUS; HUMANS; PROTEIN STABILITY; PROTOZOAN PROTEINS; REGRESSION ANALYSIS; TEMPERATURE; TIME FACTORS; VACCINES;

EID: 84903314778     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.14.96     Document Type: Article

References (15)

1. Plotkin SA. Correlates of protection induced by vaccination. Clin. Vaccine Immunol. 17(7), 1055-1065 (2010
2. WHO. Correlates of Vaccine-Induced Protection: Methods and Implications WHO, Geneva, Switzerland (2013
3. Kostense S, Hendriks J. Challenges of immunogenicity assays for vaccines. Bioanalysis 4(4), 397-406 (2012
4. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine. Guidance for Industry-Bioanalytical Method Validation. (2001). www.fda.gov/downloads/Drugs/ Guidances/ucm070107.pdf
5. EMA. Guideline on bioanalytical method validation. EMEA/CHMP/ EWP/192217/2009. EMA, London, UK (2012
6. Viswanathan CT, Bansal S, Booth B et al. Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays. Pharm. Res. 24(10), 1962-1973 (2007
7. Lee JW, Devanarayan V, Barrett YC et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23(2), 312-328 (2006
8. Shankar G, Devanarayan V, Amaravadi L et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J. Pharm. Biomed. Anal. 48(5), 1267-1281 (2008
9. ISBER (International Society for Biological and Environmental Repositories). Best practices for repositories I: Collection, storage, and retrieval of human biological materials for research. Cell Preserv. Technol. 3, 5-48 (2005
10. Kostense S, Mommaas B, Hendriks J et al. A peptide-based Plasmodium falciparum circumsporozoite assay to test for serum antibody responses to pre-erythrocyte malaria vaccines. Clin. Vaccine Immunol. 18(5), 776-782 (2011
11. Sprangers MC, Lakhai W, Koudstaal W et al. Quantifying adenovirus-neutralizing antibodies by luciferase transgene detection: Addressing preexisting immunity to vaccine and gene therapy vectors. J. Clin. Microbiol. 41, 5046-5052 (2003
12. Walker E, Nowacki AS. Understanding equivalence and noninferiority testing. J. Gen. Intern. Med. 26(2), 192-196 (2011
13. Kratz A, Ferraro M, Sluss PM et al. Laboratory reference values. N. Engl. J. Med. 351(15), 1548-1563 (2004
14. van Epps DE, Williams RC. Serum chemotactic inhibitory activity: Heat activation of chemotactic inhibition. Infect. Immun. 13(3), 741-749 (1976
15. World Health Organization. WHO Technical Report, Series No. 924. WHO, Geneva, Switzerland (2004.