Stability of anti-immunotherapeutic antibodies in frozen human serum samples

Bioanalysis

Volumn 6, Issue 10, 2014, Pages 1395-1407

  Michaut, Lydia ^a   Laurent, Nathalie ^a   Kentsch, Kerstin ^a   Spindeldreher, Sebastian ^a   Deckert Salva, Fabienne ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN G ANTIBODY; IMMUNOGLOBULIN M ANTIBODY; ANTIBODY; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; VACCINE;

ANTIBODY TITER; ARTICLE; BLOOD ANALYSIS; BLOOD SAMPLING; CONTROLLED STUDY; ENZYME LINKED IMMUNOSORBENT ASSAY; FREEZE THAWING; HUMAN; HUMORAL IMMUNITY; IMMUNOGENICITY; MOLECULAR STABILITY; QUANTITATIVE ANALYSIS; RECEPTOR BINDING ASSAY; STORAGE TEMPERATURE; TEMPERATURE SENSITIVITY; VALIDATION STUDY; BLOOD; FINANCIAL MANAGEMENT; FREEZING; IMMUNOLOGY; METABOLISM; PROTEIN STABILITY; TEMPERATURE; TIME; VACCINATION;

ANTIBODIES; ENZYME-LINKED IMMUNOSORBENT ASSAY; FREEZING; HUMANS; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; OUTSOURCED SERVICES; PROTEIN STABILITY; TEMPERATURE; TIME FACTORS; VACCINATION; VACCINES;

EID: 84903309463     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.14.97     Document Type: Article

References (11)

1. Gorovitz B Antidrug antibody assay validation: Industry survey results. Meeting report. AAPS J. 1e(1) 133-138 (2009
2. Wiessner C, Wiederhold KH, Tissot AC et al. The second-generation active Abeta immunotherapy CAD106 reduces amyloid accumulation in APP transgenic mice while minimizing potential side effects. J. Neurosci. 31(25), 9323-9331 (2011
3. Winblad B, Andreasen N, Minthon L et al. Safety, tolerability, and antibody response of active Abeta immunotherapy with CAD106 in patients with Alzheimer's disease: Randomised, double-blind, placebo-controlled, firstin-human study. Lancet Neurol. 11(7), 597-604 (2012
4. EMA. Committee for Medical Products for Human Use. Guideline on Bioanalytical Method Validation. EMA, London, UK (2011
5. Fast DM, Kelley M, Viswanathan CT et al. Workshop report and follow-up-AAPS workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples-Implications of Crystal City recommendations. AAPS J. 11(2), 238-241 (2009
6. Collins AM, Jackson KJL. A temporal model of human IgE and IgG antibody function. Front. Immunol. 4, 235 (2013
7. Timmerman P, Luedtke S, van Amsterdam P et al. Incurred sample reproducibility: Views and recommendations by the European Bioanalysis Forum. Bioanalysis 1(6), 1049-1056 (2009
8. Hendriks J, Stals C, Versteilen A et al. Stability studies of binding and functional anti-vaccine antibodies. Bioanalysis 6(10), 1385-1393 (2014
9. USP Immunogenicity Testing Expert Panel. US Pharmacopeial Guidance on Immunogenicity assays-design and validation of immunoassays to detect anti-drug antibodies. First supplement to USP 36-NF 31 (2012). www.usp.org/usp-nf/ pharmacopeial-forum
10. Shankar G, Devanarayan V, Amaravadi L et al. Recommendation for the validation of immunoassays used for detection of host antibodies against biotechnology products. J. Pharm. Biomed. Anal. 48(5), 1267-1281 (2008
11. Pihl S, Michaut L, Hendriks J et al. EBF recommendation for stability testing of anti-drug antibodies; lessons learned from anti-vaccine antibody stability studies. Bioanalysis 6(10), 1409-1413 (2014.