Neutralizing Antibody Validation Testing and Reporting Harmonization.

Antibodies, Neutralizing Pharmaceutical Preparations Drug Tolerance
FDA anti-drug antibodies (ADA) immunogenicity neutralizing antibodies (NAb) regulatory guidance validation

Journal

The AAPS journal
ISSN: 1550-7416
Titre abrégé: AAPS J
Pays: United States
ID NLM: 101223209

Informations de publication

Date de publication:
08 07 2023
Historique:
received: 27 04 2023
accepted: 05 06 2023
medline: 10 7 2023
pubmed: 8 7 2023
entrez: 8 7 2023
Statut: epublish

Résumé

Evolving immunogenicity assay performance expectations and a lack of harmonized neutralizing antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sponsors on resolving filing queries. A team of experts within the American Association of Pharmaceutical Scientists' Therapeutic Product Immunogenicity Community across industry and the Food and Drug Administration addressed challenges unique to cell-based and non-cell-based neutralizing antibody assays. Harmonization of validation expectations and data reporting will facilitate filings to health authorities and are described in this manuscript. This team provides validation testing and reporting strategies and tools for the following assessments: (1) format selection; (2) cut point; (3) assay acceptance criteria; (4) control precision; (5) sensitivity including positive control selection and performance tracking; (6) negative control selection; (7) selectivity/specificity including matrix interference, hemolysis, lipemia, bilirubin, concomitant medications, and structurally similar analytes; (8) drug tolerance; (9) target tolerance; (10) sample stability; and (11) assay robustness.

Identifiants

DOI: 10.1208/s12248-023-00830-5 PMID: 37421491
pubmed: 37421491
doi: 10.1208/s12248-023-00830-5
pii: 10.1208/s12248-023-00830-5
doi:

Substances chimiques

Antibodies, Neutralizing 0
Pharmaceutical Preparations 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

69

Informations de copyright

© 2023. The Author(s).

Références

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.
pubmed: 15251407
Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods. 2008;333(1–2):1–9.
pubmed: 18275969
Draft Guidance for Industry. Immunogenicity assessment for therapeutic protein products. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); 2013.
Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products Guidance for Industry, Draft Guidance. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH). 2016.
Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); 2019.
Guideline on Immunogenicity assessment of therapeutic proteins. European Medicines Agency, EMEA/CHMP/BMWP/14327/2006 Rev 1; 2017.
Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use European Medicines Agency, EMA/CHMP/BMWP/86289/2010; 2012.
Wu B, Chung S, Jiang XR, McNally J, Pedras-Vasconcelos J, Pillutla R, et al. Strategies to determine assay format for the assessment of neutralizing antibody responses to biotherapeutics. AAPS J. 2016;18(6):1335–50.
pubmed: 27495119
Gupta S, Devanarayan V, Finco D, Gunn GR 3rd, Kirshner S, Richards S, et al. Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics. J Pharm Biomed Anal. 2011;55(5):878–88.
pubmed: 21531522
Finco D, Baltrukonis D, Clements-Egan A, Delaria K, Gunn GR 3rd, Lowe J, et al. Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics. J Pharm Biomed Anal. 2011;54(2):351–8.
pubmed: 20863644
Wu Y, Akhgar A, Li JJ, Yu B, Chen C, Lee N, et al. Selection of a ligand-binding neutralizing antibody assay for benralizumab: comparison with an antibody-dependent cell-mediated cytotoxicity (ADCC) cell-based assay. AAPS J. 2018;20(3):49.
pubmed: 29541868
Hu J, Wala I, Han H, Nagatani J, Barger T, Civoli F, et al. Comparison of cell-based and non-cell-based assay platforms for the detection of clinically relevant anti-drug neutralizing antibodies for immunogenicity assessment of therapeutic proteins. J Immunol Methods. 2015;419:1–8.
pubmed: 25795420
Stevenson L, Richards S, Pillutla R, Torri A, Kamerud J, Mehta D, et al. 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). Bioanalysis. 2018;10(24):1973–2001.
pubmed: 30488726
Gupta S, Richards S, Amaravadi L, Piccoli S, Desilva B, Pillutla R, et al. 2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays). Bioanalysis. 2017;9(24):1967–96.
pubmed: 29205064
Xu W, Maas B, Roadcap B, Swarup A, Steinmetz T, Luo L, et al. Neutralization activity of anti-drug antibodies against a biotherapeutic can be predicted from a comprehensive pharmacokinetics, pharmacodynamics, and anti-drug antibody data analysis. AAPS J. 2022;24(6):102.
pubmed: 36167856
Myler H, Pedras-Vasconcelos J, Phillips K, Hottenstein CS, Chamberlain P, Devanaryan V, et al. Anti-drug antibody validation testing and reporting harmonization. AAPS J. 2021;24(1):4.
pubmed: 34853961
Gupta S, Indelicato SR, Jethwa V, Kawabata T, Kelley M, Mire-Sluis AR, et al. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J Immunol Methods. 2007;321(1–2):1–18.
pubmed: 17307199
Devanarayan V, Smith WC, Brunelle RL, Seger ME, Krug K, Bowsher RR. Recommendations for systematic statistical computation of immunogenicity cut points. AAPS J. 2017;19(5):1487–98.
pubmed: 28733862
Hoffman D, Berger M. Statistical considerations for calculation of immunogenicity screening assay cut points. J Immunol Methods. 2011;373(1–2):200–8.
pubmed: 21906599
Pharmacopeia US. United States Pharmacopeia. General Chapter, 〈1106〉 Immunogenicity assays—design and validation of immunoassays to detect anti-drug antibodies. . Rockville, MD: United States Pharmacopeia 2022.
Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal. 2008;48(5):1267–81.
pubmed: 18993008
Shen M, Dong X, Tsong Y. Statistical evaluation of several methods for cut-point determination of immunogenicity screening assay. J Biopharm Stat. 2015;25(2):269–79.
pubmed: 25356783
Song S, Yang L, Trepicchio WL, Wyant T. Understanding the supersensitive anti-drug antibody assay: unexpected high anti-drug antibody incidence and its clinical relevance. J Immunol Res. 2016;2016:3072586.
pubmed: 27340678 pmcid: 4906211
Zhang L, Zhang JJ, Kubiak RJ, Yang H. Statistical methods and tool for cut point analysis in immunogenicity assays. J Immunol Methods. 2013;389(1–2):79–87.
pubmed: 23305975
Shen M, Dai T. Statistical methods of screening cut point determination in immunogenicity studies. Bioanalysis. 2021;13(7):551–63.
pubmed: 33755515
Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. AAPS J. 2014;16(4):658–73.
pubmed: 24764037 pmcid: 4070270
Tan CY, Steeno GS, You Z, Gaitonde P, Cai CH, Kamerud J, et al. Criteria to reevaluate anti-drug antibody assay cut point suitability in the target population. AAPS J. 2020;22(2):19.
pubmed: 31900604
Schneider AK, Vainshtein I, Roskos LK, Chavez C, Sun B, Liang M. An immunoinhibition approach to overcome the impact of pre-existing antibodies on cut point establishment for immunogenicity assessment of moxetumomab pasudotox. J Immunol Methods. 2016;435:68–76.
pubmed: 27220271
Kumar SC, DelCarpini JA, Qu Q, Kane M, Gorovits B. Mitigation of pre-existing antibodies to a biotherapeutic in non-clinical species when establishing anti-drug antibody assay cutpoint. AAPS J. 2017;19(1):313–9.
pubmed: 27873117
Lofgren JA, Wala I, Koren E, Swanson SJ, Jing S. Detection of neutralizing anti-therapeutic protein antibodies in serum or plasma samples containing high levels of the therapeutic protein. J Immunol Methods. 2006;308(1–2):101–8.
pubmed: 16356511
Xu W, Jiang H, Titsch C, Haulenbeek JR, Pillutla RC, Aubry AF, et al. Development and characterization of a pre-treatment procedure to eliminate human monoclonal antibody therapeutic drug and matrix interference in cell-based functional neutralizing antibody assays. J Immunol Methods. 2015;416:94–104.
pubmed: 25445325
Zoghbi J, Xu Y, Grabert R, Theobald V, Richards S. A breakthrough novel method to resolve the drug and target interference problem in immunogenicity assays. J Immunol Methods. 2015;426:62–9.
pubmed: 26255760
Xiang Y, Kamerud J, Donley J, Olson K, Caiazzo T, Yeung D, et al. Approaches to resolve false reporting in neutralizing antibody assays caused by reagent leaching from affinity capture elution solid phase. AAPS J. 2018;21(1):4.
pubmed: 30402825
Jiang Z, Kamerud J, Zhang M, Ruiz CC, Guadiz C, Fichtner A, et al. Strategies to develop highly drug-tolerant cell-based neutralizing antibody assay: neutralizing antidrug antibodies extraction and drug depletion. Bioanalysis. 2020;12(18):1279–93.
pubmed: 32945693
Wickramarachchi D, Steeno G, You Z, Shaik S, Lepsy C, Xue L. Fit-for-purpose validation and establishment of assay acceptance and reporting criteria of dendritic cell activation assay contributing to the assessment of immunogenicity risk. AAPS J. 2020;22(5):114.
pubmed: 32839919
Smith HW, Butterfield A, Sun D. Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation (SPEAD) sample treatment prior to ELISA. Regul Toxicol Pharmacol. 2007;49(3):230–7.
pubmed: 17869396
Wu B, Schnarr M, Devlin JL, Brown S, Yang TY. Approaches to improve drug tolerance and target tolerance in the assessment of neutralizing anti-drug antibodies. Bioanalysis. 2019;11(22):2061–74.
pubmed: 31829737
Bourdage JS, Cook CA, Farrington DL, Chain JS, Konrad RJ. An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug. J Immunol Methods. 2007;327(1–2):10–7.
pubmed: 17716682
Zhong ZD, Clements-Egan A, Gorovits B, Maia M, Sumner G, Theobald V, et al. Drug target interference in immunogenicity assays: recommendations and mitigation strategies. AAPS J. 2017;19(6):1564–75.
pubmed: 29063411
Ghermezi M, Li M, Vardanyan S, Harutyunyan NM, Gottlieb J, Berenson A, et al. Serum B-cell maturation antigen: a novel biomarker to predict outcomes for multiple myeloma patients. 2017;102(4):785–95.
Mistry P, Reid J, Pouliquen I, McHugh S, Abberley L, DeWall S, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose antiinterleukin- 18 mAb GSK1070806 in healthy and obese subjects. Int J Clin Pharmacol Ther. 2014;52(10):867–79.
pubmed: 25109413
Lachmann HJ, Lowe P, Felix SD, Rordorf C, Leslie K, Madhoo S, et al. In vivo regulation of interleukin 1beta in patients with cryopyrin-associated periodic syndromes. J Exp Med. 2009;206(5):1029–36.
pubmed: 19364880 pmcid: 2715040
Pouliquen IJ, Kornmann O, Barton SV, Price JA, Ortega HG. Characterization of the relationship between dose and blood eosinophil response following subcutaneous administration of mepolizumab. Int J Clin Pharmacol Ther. 2015;53(12):1015–27.
pubmed: 26445140 pmcid: 4647865
Pihl S, Michaut L, Hendriks J, Loebbert R, Ryding J, Nemansky M, et al. EBF recommendation for stability testing of anti-drug antibodies; lessons learned from anti-vaccine antibody stability studies. Bioanalysis. 2014;6(10):1409–13.
pubmed: 24958124
Michaut L, Laurent N, Kentsch K, Spindeldreher S, Deckert-Salva F. Stability of anti-immunotherapeutic antibodies in frozen human serum samples. Bioanalysis. 2014;6(10):1395–407.
pubmed: 24958123
Cowan KJ, Erickson R, Sue B, Delarosa R, Gunter B, Coleman DA, et al. Utilizing design of experiments to characterize assay robustness. Bioanalysis. 2012;4(17):2127–39.
pubmed: 23013395
Pihl S, van der Strate BW, Golob M, Vermet L, Jaitner B, Goodman J, et al. EBF recommendation on practical management of critical reagents for PK ligand-binding assays. Bioanalysis. 2018;10(19):1557–65.
pubmed: 30226086
Guideline on bioanalytical method validation. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP); 2011.
Bioanalytical Method Validation Guidance for Industry. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM); 2018.
Bioanalytical Method Validation and Study Sample Analysis M10. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; 2022.
Booth B, Vazvaei F, Fluhler E, Myler H, Woolf E. AAPS Workshop Report on ICH M10. AAPS J. 2019;22(1):10.
pubmed: 31823177
Kim JS, Kim SH, Kwon B, Hong S. Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13). Expert Rev Clin Immunol. 2015;11(Suppl 1):S33-41.
pubmed: 26395835
Lofgren JA, Dhandapani S, Pennucci JJ, Abbott CM, Mytych DT, Kaliyaperumal A, et al. Comparing ELISA and surface plasmon resonance for assessing clinical immunogenicity of panitumumab. J Immunol. 2007;178(11):7467–72.
pubmed: 17513798
Mora JR, White JT, Chilewski SD, Qu Q, Stocker D, Luo L, et al. Strategies for method comparison when changes in the immunogenicity method are needed within a clinical program. Bioanalysis. 2020;12(7):431–43.
pubmed: 32343147
Peng K, Siradze K, Quarmby V, Fischer SK. Clinical immunogenicity specificity assessments: a platform evaluation. J Pharm Biomed Anal. 2011;54(3):629–35.
pubmed: 21035975
Qiu ZJ, Ying Y, Lewin-Koh SC, Coleman D, Brignoli S, Hendricks R, et al. Strategies to compare clinical antitherapeutic antibody data when changing assay platforms: a case study. Bioanalysis. 2015;7(14):1775–83.
pubmed: 26270784
Chamberlain P. Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers. Bioanalysis. 2019;11(17):1581–92.
pubmed: 30767660
Xue L, Clements-Egan A, Amaravadi L, Birchler M, Gorovits B, Liang M, et al. Recommendations for the assessment and management of pre-existing drug-reactive antibodies during biotherapeutic development. AAPS J. 2017;19(6):1576–86.
pubmed: 29110222
Gorovits B, Clements-Egan A, Birchler M, Liang M, Myler H, Peng K, et al. Pre-existing antibody: biotherapeutic modality-based review. AAPS J. 2016;18(2):311–20.
pubmed: 26821802 pmcid: 4779092
In Vitro Companion Diagnostic Devices. Guidance for industry and food and drug administration staff. food and drug administration, center for devices and radiological health; 2014.

Auteurs

Heather Myler (H)

Bioanalytical and Biomarker Science and Technologies, Takeda, Cambridge, MA, 02139, USA. heather.myler@takeda.com.
25 Creekview Ln, Yardley, Pennsylvania, 19067, USA. heather.myler@takeda.com.

João Pedras-Vasconcelos (J)

Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20903, USA.

Todd Lester (T)

BioAgilytix Labs, Durham, North Carolina, 27713, USA.

Francesca Civoli (F)

Coherus BioSciences, 333 Twin Dolphin Drive, Redwood City, California, 94065, USA.

Weifeng Xu (W)

Regulated Global Bioanalytics, Merck & Co., Inc, Rahway, New Jersey, 07065, USA.

Bonnie Wu (B)

Bioanalytical Discovery and Development Sciences, Janssen Research and Development, Spring House, Pennsylvania, 19477, USA.

Inna Vainshtein (I)

Discovery and Translational Research, Exelixis, 1851 Harbor Bay Pkwy, Alameda, California, 94502, USA.

Linlin Luo (L)

Regulated Global Bioanalytics, Merck & Co., Inc, Rahway, New Jersey, 07065, USA.

Mohamed Hassanein (M)

Early Clinical Development, Precision Medicine, Pfizer Inc, Cambridge, Massachusetts, USA.

Susana Liu (S)

Global Product Development, , Pfizer Inc, 17300 Trans Canada Hwy, Kirkland, Quebec, Canada.

Swarna Suba Ramaswamy (SS)

Regulated Bioanalysis Department, B2S Life Sciences, 97 East Monroe Street, Franklin, Indiana, 46131, USA.

Johanna Mora (J)

Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA.

Jason Pennucci (J)

Quantitative Bioanalytics, Moderna, 200 Technology Square, Cambridge, Massachusetts, 02139, USA.

Fred McCush (F)

Clinical Pharmacology, Pfizer Inc, Eastern Point Road, Groton, CT, 06379, USA.

Amy Lavelle (A)

Bioanalytical Lab, PPD Clinical Research, , 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA.

Darshana Jani (D)

Preclinical and Clinical Bioanalysis, , Moderna Tx, 200 Technology Square, Cambridge, Massachusetts, 02142, USA.

Angela Ambakhutwala (A)

Immunology Sciences, Kriya Therapeutics, 4105 Hopson Road, Morrisville, North Carolina, 27560, USA.

Daniel Baltrukonis (D)

Clinical Pharmacology, Pfizer Inc, Eastern Point Road, Groton, CT, 06379, USA.

Breann Barker (B)

Drug Metabolism and Biopharmaceuticals, Incyte Corporation, 1801 Augustine Cut-Off, Wilmington, Delaware, 19803, USA.

Rebecca Carmean (R)

Bioanalytical Lab, PPD Clinical Research, , 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA.

Shan Chung (S)

Department of BioAnalytical Sciences, Genentech Inc, South San Francisco, California, USA.

Sheng Dai (S)

Quantitative Clinical Pharmacology & Translational Sciences (QCP), Daiichi Sankyo, Inc, 211 Mt. Airy Road, Basking Ridge, New Jersey, 07920, USA.

Stephen DeWall (S)

Bioanalytical Sciences, Scholar Rock, 301 Binney Street, 3rd Floor, Cambridge, Massachusetts, 02142-1071, USA.

Sanjay L Dholakiya (SL)

Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA.

Robert Dodge (R)

Novartis Institutes for BioMedical Research, 1 Health Plaza, East Hanover, New Jersey, 07936, USA.

Deborah Finco (D)

Deborah Finco Consulting LLC, 101 Prospect Hill Road, Groton, Connecticut, 06340, USA.

Haoheng Yan (H)

Global Regulatory Affairs, Shanghai Henlius Biotech. Inc, 430 N. McCarthy Blvd, Milpitas, California, 95035, USA.

Amanda Hays (A)

BioAgilytix Labs, Durham, North Carolina, 27713, USA.

Zheng Hu (Z)

Translation Safety & Bioanalytical Science, Amgen Inc, Thousand Oaks, California, 91360, USA.

Cynthia Inzano (C)

Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA.

Lynn Kamen (L)

BioAgilytix Labs, Durham, North Carolina, 27713, USA.

Ching-Ha Lai (CH)

Bioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA.

Erik Meyer (E)

Immunogenicity, GSK Pharmaceuticals, 1250 South Collegeville Road, Collegeville, Pennsylvania, 19426, USA.

Robert Nelson (R)

Bioanalytical Services, Labcorp Drug Development, Otley Road, Harrogate, HG3 1PY, UK.

Amrit Paudel (A)

Research Center Pharmaceutical Engineering GmbH (RCPE), Inffeldgasse 13, 8010, Graz, Austria.

Kelli Phillips (K)

Clinical Pharmacology, Pfizer Inc, Eastern Point Road, Groton, CT, 06379, USA.

Marie-Eve Poupart (ME)

Immunology, Charles River Laboratories, Montreal ULC, Transcanada Highway, Senneville, Quebec, 22022, Canada.

Qiang Qu (Q)

Quantitative Bioanalytics, Moderna, 200 Technology Square, Cambridge, Massachusetts, 02139, USA.

Mohsen Rajabi Abhari (MR)

Office of Clinical PharmacologyOffice of Translational SciencesCenter for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20903, USA.

Janka Ryding (J)

Bioanalysis-Biologics, Lundbeck A/S, Ottiliavej 9, 2500, Valby, Denmark.

Curtis Sheldon (C)

Technical Operations, , IVERIC Bio, Inc, 8 Sylvan Way, Parsippany, New Jersey, 07054, USA.

Franklin Spriggs (F)

Spriggs Bioanalytical Consulting LLC, 15632 W 83rd Terrace, Lenexa, Kansas, 66219, USA.

Dominic Warrino (D)

Bioanalytical and Biomarker Services, KCAS, 10830 S Clay Blair Blvd, Olathe, Kansas, 66061, USA.

Yuling Wu (Y)

Integrated Bioanalysis, , AstraZeneca, Gaithersburg, Maryland, 20878, USA.

Lin Yang (L)

Bioanalytical Sciences, REGENXBIO Inc, 9804 Medical Center Drive, Rockville, Maryland, 20850, USA.

Stephanie Pasas-Farmer (S)

BioData Solutions, 1021 ½ Massachusetts Street, Lawrence, Kansas, 66044, USA.

Articles similaires

Impact of supply chain disruptions and drug shortages on drug utilization: A scoping review protocol.

Araniy Santhireswaran, Martin Ho, Kaitlin Fuller et al.
1.00
Humans Pharmaceutical Preparations Drug Utilization Prescription Drugs

Auto-Abs neutralizing type I IFNs in patients with severe Powassan, Usutu, or Ross River virus disease.

Adrian Gervais, Paul Bastard, Lucy Bizien et al.
1.00
Humans Interferon Type I Ross River virus Encephalitis, Tick-Borne Antibodies, Neutralizing

Absolute concentration estimation of COVID-19 convalescent and post-vaccination IgG antibodies.

Melvin E Klegerman, Tao Peng, Ira Seferovich et al.
1.00
Humans COVID-19 Immunoglobulin G Antibodies, Viral SARS-CoV-2

Ad5-nCoV boosted vaccine and reinfection-induced memory T/B cell responses and humoral immunity to SARS-CoV-2: based on two prospective cohorts.

Aidibai Simayi, Yuxin Chen, Jinjin Chu et al.
1.00
Humans COVID-19 SARS-CoV-2 Antibodies, Viral Immunity, Humoral

Classifications MeSH

questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Globulines › Sérum-globulines › Immunoglobulines › Anticorps › Anticorps neutralisants › Neutralizing Antibody Validation Testing and...
questionsmedicales.fr › Préparations pharmaceutiques › Neutralizing Antibody Validation Testing and...
questionsmedicales.fr › Phénomènes physiologiques › Phénomènes pharmacologiques et toxicologiques › Phénomènes pharmacologiques › Tolérance aux médicaments › Neutralizing Antibody Validation Testing and...