Ligand binding assay critical reagents and their stability: Recommendations and best practices from the global bioanalysis consortium harmonization team

AAPS Journal

Volumn 16, Issue 3, 2014, Pages 504-515

  King, Lindsay E ^a   Farley, Esme ^b   Imazato, Mami ^c   Keefe, Jeannine ^d   Khan, Masood ^e   Ma, Mark ^f   Pihl, K Susanne ^g   Sriraman, Priya ^h  

^a PFIZER INC   (United States)

^b IQVIA   (United States)

^c NOVARTIS PHARMA K K   (Japan)

^d BIOGEN   (United States)

^e KCAS   (United States)

^f AMGEN INC   (United States)

^g H LUNDBECK A S   (Denmark)

^h CELGENE CORPORATION   (United States)

Author keywords

critical reagents; ligand binding assays; lot changes; recommendations; stability

Indexed keywords

DRUG ANTIBODY; REAGENT; BIOLOGICAL MARKER; DYES, REAGENTS, INDICATORS, MARKERS AND BUFFERS; LIGAND;

ARTICLE; CALIBRATION; CONJUGATION; CROSS REACTION; DOCUMENTATION; IMMUNOGENICITY; INVENTORY CONTROL; MOLECULAR STABILITY; QUALITY CONTROL; RECEPTOR BINDING ASSAY; SHELF LIFE; STORAGE; VALIDATION PROCESS; CHEMISTRY; HUMAN; PHARMACOKINETICS; STANDARD; STANDARDS; SUPPLY AND DISTRIBUTION;

BIOLOGICAL MARKERS; DOCUMENTATION; HUMANS; INDICATORS AND REAGENTS; LIGANDS; PHARMACOKINETICS; REFERENCE STANDARDS;

EID: 84900308760     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-014-9583-x     Document Type: Article

References (33)

1. DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res. 2003;20(11):1885-900. (Pubitemid 37449466)
2. Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods. 2004;289(1-2):1-16. (Pubitemid 38900899)
3. Nowatzke W, Woolf E. Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples. AAPS J. 2007;9(2):E117-22. (Pubitemid 46690951)
4. Rup B, O'Hara D. Critical ligand binding reagent preparation/selection: when specificity depends on reagents. AAPS J. 2007;9(1):E148-55. (Pubitemid 46812920)
5. Staack RF, Stracke JO, Stubenrauch K, Vogel R, Schleypen J, Papadimitriou A. Quality requirements for critical assay reagents used in bioanalysis of therapeutic proteins: what bioanalysts should know about their reagents. Bioanalysis. 2011;3(5):523-34. doi:10.4155/bio.11.16.
6. O'Hara DM, Theobald V, Egan AC, Usansky J, Krishna M, TerWee J, et al. Ligand binding assays in the 21st century laboratory: recommendations for characterization and supply of critical reagents. AAPS J. 2012;14(2):316-28. doi:10.1208/s12248-012-9334-9.
7. US 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. Fed Regist. 2001;66(100):28526.
8. European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on bioanalytical method validation. EMEA/CHMP/EWP/192217/2009 21 Jul 2011.
9. Clinical Laboratory Standards Institute (Formerly NCCLS). Assessing the quality of immunoassay systems: radioimmunoassays and enzyme, fluorescence, and luminescence immunoassays; approved guideline. NCCLS I/LA23-A 2004;24 (16).
10. Geist BJ, Egan AC, Yang TY, Dong Y, Shankar G. Characterization of critical reagents in ligand-binding assays: enabling robust bioanalytical methods and lifecycle management. Bioanalysis. 2013;5(2):227-44. doi:10.4155/bio.12.304.
11. Polifke T. Introduction to biochemicals and chemical reagents. IVD Technology [Internet]. 2010 Oct 16(6). http://www.ivdtechnology.com/article/ introduction-biochemicals-and-chemical-reagents-0.
12. Ezzelle J, Rodriguez-Chavez IR, Darden JM, Stirewalt M, Kunwar N, Hitchcock R, et al. Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. J Pharm Biomed Anal. 2008;46(1):18-29. (Pubitemid 350216340)
13. Khan MN, Dass PD, Leete JH, Schuman RF, Gunsior M, Sadhu C. Development of ligand-binding assays for drug development support. In: Khan MN, Findlay JW, editors. Ligand-binding assays: development, validation, and implementation in the drug development Arena. Hoboken: Wiley; 2009. p. 39-79.
14. Miller WG, Erek A, Cunningham TD, Oladipo O, Scott MG, Johnson RE. Commutability limitations influence quality control results with different reagent lots. Clin Chem. 2011;57(1):76-83.
15. Myler HA, Phillips KR, Dong H, Tabler E, Shaikh M, Coats V, et al. Validation and life-cycle management of a quantitative ligand-binding assay for the measurement of Nulojix®, a CTLA-4-Fc fusion protein, in renal and liver transplant patients. Bioanalysis. 2012;4(10):1215-26.
16. van Amsterdam P, Companjen A, Brudny-Kloeppel M, Golob M, Luedtke S, Timmerman P. The European Bioanalysis Forum community's evaluation, interpretation and implementation of the European Medicines Agency guideline on bioanalytical method validation. Bioanalysis. 2013;5(6):645-50.
17. Anderson G, Scott M. Determination of product shelf life and activation energy for fi ve drugs of abuse. Clin Chem. 1991;37(3):398-402. (Pubitemid 21892661)
18. Kirkwood TB. Predicting the stability of biological standards and products. Biometrics. 1977;33(4):736-42. (Pubitemid 8236344)
19. Wang W, Singh S, Zeng DL, King K, Nema S. Antibody structure, instability, and formulation. J Pharm Sci. 2007;96(1):1-26. (Pubitemid 46087335)
20. Haldar S, Mitra S, Chattopadhyay K. Role of protein stabilizers on the conformation of the unfolded state of cytochrome c and its early folding kinetics: investigation at single molecular resolution. J Biol Chem. 2010;285(33):25314-23. doi:10.1074/jbc.M110.116673.
21. Falconer RJ, Chan C, Hughes K, Munro T. Stabilization of a monoclonal antibody during purification and formulation by addition of basic amino acid excipients. J Chem Technol Biotechnol. 2011;86:942-8.
22. Chang BS, Yeung B. Physical stability of protein pharmaceuticals. In: Jameel F, Hershenson S, editors. Formulation and process development strategies for manufacturing biopharmaceuticals. Hoboken: Wiley; 2010. p. 69-104.
23. van de Weert M, Randolph TW. Physical instability of peptide and proteins. In: Hovgaard L, Frokjaer S, van de Weert M, editors. Pharmaceutical formulation development of peptides and proteins. Boca Raton: Taylor and Francis; 2012. p. 107-30.
24. Meyer BK, Ni A, Hu B, Shi L. Antimicrobial preservative use in parenteral products: past and present. J Pharm Sci. 2007;96(12):3155-67.
25. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: container closure systems for packaging human drugs and biologics. Chemistry, manufacturing, and controls documentation. Fed Regist. 1999;64(129):36694.
26. ICH Harmonised Tripartite Guideline. Bracketing and matrixing designs for stability testing of new drug substances and products. Q1D. US Fed Regist 16 Jan 2003;68(11) 2339. CPMP/ICH/4104/00 February 2002. MHLW PFSB/ELD Notification No. 0731004 31 Jul 2002.
27. Westgard JO, Klee GG. Quality management. In: Burtis CA, Ashwood ER, editors. Tietz textbook of clinical chemistry. 3rd ed. Philadelphia: W.B. Saunders; 1999. p. 407.
28. Krause PR. Goals of stability evaluation throughout the vaccine life cycle. Biologicals. 2009;37(6):369-78.
29. US Department of Health and Human Services, Food and Drug Administration. Good laboratory practice for nonclinical laboratory studies. 21CFR 58. Fed Regist. 1976;41(225):51206 (Proposed Regulations) and
30. Federal Register 43(247) 59986 22 December 1978 (Final Rule).
31. ICH Harmonised Tripartite Guideline. Validation of analytical procedures: text and methodology Q2(R1). US Fed Regist 19 May 1997;62(96) 27463. CPMP/ICH281/95 December 1996. MHLW PMSB/ELD Notification No. 338 October 1997.
32. Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, et al . Workshop/conference report - quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 2007;9(1):E30-42. (Pubitemid 46296546)
33. Bunk DM, Welch MJ. Characterization of a new certified reference material for human cardiac troponin I. Clin Chem. 2006;52(2):212-9. (Pubitemid 43185481)