Review & Monography

Progress and technical requirements for ligand binding analysis of singlicate analysis in bioanalysis

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  • Shanghai Center for Drug Evaluation and Inspection, Shanghai 201210, China

Revised date: 2023-03-07

  Online published: 2024-06-25

Abstract

Replicate analysis is the standard practice of ligand binding analysis(LBA) in bioanalysis, which is to reduce the variability of the analysis. With the progress of analytical instrument technology and the improvement of reagent quality, especially the automation application, the precision of LBA has been significantly improved, the bioanalysis industry is asking whether LBA could also be single-pore assayed as LC-MS. In recent years, ICH M10 (Draft for comment) has accepted the singlicate analysis, and several industry organizations or research institutions have carried out comparative studies of singlicate and replicate analysis. The results show that the use of singlicate analysis did not significantly affect the key parameters of toxicology kinetics(TK) and/or pharmacokinetics(PK), the critical values and sensitivity of anti drug antibody(ADA). This paper summarizes the research progress of existing literature, and propose the technical requirements of singlicate analysis application, in order to provide reference for the application of singlicate analysis in TK/PK and ADA study,and further promote the technical standards of drug registration in line with international standards.

Cite this article

LI Shuai, LI Gang, WU Hao, CHEN Gui-liang . Progress and technical requirements for ligand binding analysis of singlicate analysis in bioanalysis[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(4) : 550 -557 . DOI: 10.16155/j.0254-1793.2023.04.02

References

[1] KHA N, MASOOD N, JOHN WA. Findlay. Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena[M]. Hoboken: John Wiley & Sons, Inc, 2009: 40
[2] YALOW RS, BERSON SA. Immunoassay of endogenous plasma insulin in man[J]. J Clin Invest, 1960, 39(7):1157
[3] MIDGLEY AR JR, NISWENDER GD, REBAR RW. Principles for the assessment of the reliability of radioimmunoassay methods(precision, accuracy, sensitivity, specificity)[J]. Acta Endocrinol Suppl (Copenh), 1969, 142: 163
[4] BANKS P. The Microplate Market Past, Present and Future: Microplates Today-The Global Market[EB/OL].[2009-04-15]. https://www.ddw-online.com/t/high-throughput-screening/
[5] CLARK TH, YATES PD, CHUNYK AG, et al. Feasibility of singlet analysis for ligand binding assays: a retrospective examination of data generated using the gyrolab platform[J]. AAPS J, 2016, 18(5):1300
[6] PILLUTLA R, GOROVITS B, GLEASON C, et al. Recommendations for singlet-based approach in ligand binding assays: an IQ consortium perspective[J]. Bioanalysis, 2020, 12(12):823
[7] BIRNBOECK HF, SCHICK E, JUSTIES N. Singlicate analysis in regulated bioanalysis using ligand-binding assays: where are we heading?[J]. Bioanalysis, 2017, 9(18):1357
[8] YE Z, TU J, MIDDE K, et al. Singlicate analysis: should this be the default for biomarker measurements using ligand-binding assays?[J]. Bioanalysis, 2018, 10(12):909
[9] DUDAL S, BALTRUKONIS D, CRISINO R, et al. Assay formats: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team[J]. AAPS J, 2014, 16(2):194
[10] ICH Expert Working Group. Bioanalytical Method Validation and Study Sample Analysis M10[EB/OL].[2022-05-24]. https://database.ich.org/sites/default/files/M10_Guideline_Step4_2022_0524.pdf
[11] 中华人民共和国药典2020年版. 四部[S]. 2020: 466
ChP 2020.Vol Ⅳ[S]. 2020: 466
[12] The Office of Clinical Pharmacology in the Center for Drug Evaluation and Research and the Center for Veterinary Medicine at the Food and Drug Administration. Bioanalytical Method Validation Guidance for Industry[EB/OL].[2020-04-29]. https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf
[13] The Efficacy Working Party. Guideline on Bioanalytical Method Validation[EB/OL].[2012-02-01]. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf
[14] The Ministry of Health, Labour and Welfare. Guideline on Bioanalytical Method(Ligand Binding Assay) Validation in Pharmaceutical Development[EB/OL].[2014-05-30]. http://www.nihs.go.jp/drug/BMV/260530_LBA-GL_E.pdf
[15] BARFIELD M, GOODMAN J, HOOD J, et al. European Bioanalysis Forum recommendation on singlicate analysis for ligand binding assays: time for a new mindset[J]. Bioanalysis, 2020, 12(5):273
[16] DONALDSON D, PURUSHOTHAMA S, DAVID E, et al. Well-developed ligand-binding assays demonstrate robust performance using singlet analysis[J]. Bioanalysis, 2019, 11(22):2075
[17] JIANG Z, KAMERUD J, YOU Z, et al. Feasibility of singlicate-based analysis in bridging ADA assay on meso-scale discovery platform: comparison with duplicate analysis[J]. Bioanalysis, 2021, 13(14):1123
[18] STANTA JL, CRAIG H, SMITH C, et al. Comparing singlet and duplicate immunogenicity assay in human plasma for pembrolizumab using Gyrolab®[J]. Bioanalysis, 2021, 13(11):891
[19] JIANG H, KOZHICH A, CUMMINGS J, et al. Singlicate ligand binding assay using an automated microfluidic system: a clinical case study[J]. AAPS J, 2017, 19(5):1461
[20] WÄTZIG H, OLTMANN-NORDEN I, STEINICKE F, et al. Data quality in drug discovery: the role of analytical performance in ligand binding assays[J]. J Comput Aided Mol Des, 2015, 29(9):847
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