Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team
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The L4 Global Harmonization Team on reagents and their stability focused on the management of critical reagents for pharmacokinetic, immunogenicity, and biomarker ligand binding assays. Regulatory guidance recognizes that reagents are important for ligand binding assays but do not address numerous aspects of critical reagent life cycle management. Reagents can be obtained from external vendors or developed internally, but regardless of their source, there are numerous considerations for their reliable long-term use. The authors have identified current best practices and provided recommendations for critical reagent lot changes, stability management, and documentation.
KEY WORDScritical reagents ligand binding assays lot changes recommendations stability
We would like to acknowledge and thank the many scientists who provided feedback on the draft recommendations and completed the survey questionnaire. The feedback and information we received were very important in framing our final recommendations. We would also like to thank those who critically and carefully reviewed the final recommendations and manuscript.
- 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.PubMedCrossRefGoogle Scholar
- 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.Google Scholar
- 8.European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on bioanalytical method validation. EMEA/CHMP/EWP/192217/2009 21 Jul 2011.Google Scholar
- 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).Google Scholar
- 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.
- 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.CrossRefGoogle Scholar
- 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.PubMedCrossRefGoogle Scholar
- 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.PubMedCrossRefGoogle Scholar
- 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.PubMedCentralPubMedCrossRefGoogle Scholar
- 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.Google Scholar
- 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.Google Scholar
- 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.Google Scholar
- 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.Google Scholar
- 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 Federal Register 43(247) 59986 22 December 1978 (Final Rule).Google Scholar
- 30.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.Google Scholar