Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays

Kubiak, Robert; Lee, Nancy; Zhu, Yuan; Franch, William R.; Levitskaya, S. V.; Krishnan, Surekha R.; Abraham, Varghese; Akufongwe, P. F.; Larkin, Christopher; White, Wendy I.

doi:10.1155/2016/1485615

Cited by 20 publications

(17 citation statements)

References 13 publications

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“…To sum up, the aforementioned result proves that the proposed AuNPs–GO–anti-IgG probe has good stability and repeatability that allows the preparation of the sensing probes without a tight schedule. For long-term storage purposes, numerous studies in the literature have reported convenient and widely used methods for long-term storage of proteins [ 38 , 43 , 44 , 45 , 46 , 47 ]. These preservation methods will be explored in our future sensor prototype development to improve preservation time and stability.…”

Section: Resultsmentioning

confidence: 99%

Integrated Graphene Oxide with Noble Metal Nanoparticles to Develop High-Sensitivity Fiber Optic Particle Plasmon Resonance (FOPPR) Biosensor for Biomolecules Determination

Chen

Chiang

et al. 2021

Nanomaterials

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In this research, a direct, simple and ultrasensitive fiber optic particle plasmon resonance (FOPPR) biosensing platform for immunoglobulin G (IgG) detection was developed using a gold nanoparticle/graphene oxide (AuNP/GO) composite as signal amplification element. To obtain the best analytical performance of the sensor, experimental parameters including the surface concentration of GO on the AuNPs, formation time of the GO, the concentration of the anti-IgG and incubation time of anti-IgG were optimized. The calibration plots displayed a good linear relationship between the sensor response (ΔI/I0) and the logarithm of the analyte concentrations over a linear range from 1.0 × 10−10 to 1.0 × 10−6 g/mL of IgG under the optimum conditions. A limit of detection (LOD) of 0.038 ng/mL for IgG was calculated from the standard calibration curve. The plot has a linear relationship (correlation coefficient, R = 0.9990). The analytical performance of present work’s biosensor was better than that of our previously reported mixed self-assembled monolayer of 11-mercaptoundecanoic acid/6-mercapto-1-hexanol (MUA/MCH = 1:4) method by about three orders of magnitude. The achieved good sensitivity may be attributed to the synergistic effect between GO and AuNPs in this study. In addition, GO could immobilize more antibodies due to the abundant carboxylic groups on its surface. Furthermore, we also demonstrated that the results from this sensor have good reproducibility, with coefficients of variation (CVs) < 8% for IgG. Therefore, the present strategy provides a novel and convenient method for chemical and biochemical quantification and determination.

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Section: Resultsmentioning

confidence: 99%

Integrated Graphene Oxide with Noble Metal Nanoparticles to Develop High-Sensitivity Fiber Optic Particle Plasmon Resonance (FOPPR) Biosensor for Biomolecules Determination

Chen

Chiang

et al. 2021

Nanomaterials

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“…Ruthenium complex reagents can be prone to aggregation [37], which can impact ADA assay performance, and therefore SECbased characterization is recommended. Formulation conditions can impact stability and aggregation, especially during freeze-thaw [38]. For example, pH can influence aggregation.…”

Section: Critical Reagent Characterizationmentioning

confidence: 99%

2018 White Paper on Recent Issues in Bioanalysis: Focus on Flow Cytometry, Gene Therapy, Cut Points and Key Clarifications on Bav (Part 3 – Lba/Cell-Based Assays: Immunogenicity, Biomarkers and Pk Assays)

et al. 2018

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The remaining list of author names, affiliations and Regulatory Agencies Disclaimer can be found at the end of the articleThe 2018 12 th Workshop on Recent Issues in Bioanalysis took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day full immersion in bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small-and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS and LBA/cell-based assays approaches. This 2018 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2018 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for large molecule bioanalysis, biomarkers and immunogenicity using LBA and cell-based assays. Part 1 (LCMS for small molecules, peptides, oligonucleotides and small molecule biomarkers) and Part 2 (hybrid LBA/LCMS for biotherapeutics and regulatory agencies' inputs) are published in volume 10 of Bioanalysis, issues 22 and 23 (2018), respectively.

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“…EZ-Link biotin sulfo-N-hydroxysuccinimide ester was purchased from Thermo Scientific (IL, USA). Preparation of biotinylated and ruthenylated drug conjugates closely followed the procedures described elsewhere [13]. All data described here were obtained during clinical development of monoclonal antibody drug candidates 1 through 11 conducted by AstraZeneca (Table 1).…”

Section: Reagentsmentioning

confidence: 99%

Confirmatory Cut Point has Limited Ability to Make Accurate Classifications in Immunogenicity Assays

et al. 2020

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Aim: Competitive inhibition with excess unlabeled drug is used to confirm the presence of antidrug antibodies (ADA) in study samples. We evaluated specific and nonspecific responses from both drug-naive and drug-treated subjects to identify conditions required by the confirmatory assay to make accurate ADA classifications. Results: Nonspecific signal measured in drug-naive samples used to determine assay cut points was uniformly low and close to the screening cut point. Confirmatory assays performed on incurred study samples with nonspecific responses significantly above the level observed during cut point determination resulted in incorrect ADA classifications. Conclusion: Intensity of confirmatory response should be proportional to the screening response and therefore, to ensure accurate ADA classifications, the confirmatory responses cannot be considered as independent but need to be evaluated in relation to the screening responses.

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Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays

Cited by 20 publications

References 13 publications

Integrated Graphene Oxide with Noble Metal Nanoparticles to Develop High-Sensitivity Fiber Optic Particle Plasmon Resonance (FOPPR) Biosensor for Biomolecules Determination

Integrated Graphene Oxide with Noble Metal Nanoparticles to Develop High-Sensitivity Fiber Optic Particle Plasmon Resonance (FOPPR) Biosensor for Biomolecules Determination

2018 White Paper on Recent Issues in Bioanalysis: Focus on Flow Cytometry, Gene Therapy, Cut Points and Key Clarifications on Bav (Part 3 – Lba/Cell-Based Assays: Immunogenicity, Biomarkers and Pk Assays)

Confirmatory Cut Point has Limited Ability to Make Accurate Classifications in Immunogenicity Assays

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