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Critical reagent inventory management system and web portal specifically optimized for supporting external clients

Bioanalysis, 2022-06, Vol.14 (12), p.869-879

2022

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Best practices on critical reagent characterization, qualification, and life cycle management for HCP immunoassays

Biotechnology and bioengineering, 2021-10, Vol.118 (10), p.3633-3639

2021

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Determination of label efficiency and label degree of critical reagents by LC-MS and native MS

Analytical biochemistry, 2023-03, Vol.664, p.115033-115033, Article 115033

2023

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Long term investigation of formulation buffers to mitigate stability issues of conjugated critical reagents

Journal of immunological methods, 2024-10, Vol.533, p.113742, Article 113742

2024

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Critical reagents: evolution of WRIB recommendations on critical reagents

Bioanalysis, 2021-05, Vol.13 (10), p.741-743

Amaravadi, Lakshmi

2021

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Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team

The AAPS journal, 2014-05, Vol.16 (3), p.504-515

2014

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Ligand Binding Assays in the 21st Century Laboratory: Recommendations for Characterization and Supply of Critical Reagents

The AAPS journal, 2012-06, Vol.14 (2), p.316-328

2012

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Monitoring CAR‐T cell kinetics in clinical trials by multiparametric flow cytometry: Benefits and challenges

Cytometry. Part B, Clinical cytometry, 2021-01, Vol.100 (1), p.72-78

2021

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EBF recommendation on practical management of critical reagents for antidrug antibody ligand-binding assays

Bioanalysis, 2019-10, Vol.11 (19), p.1787-1798

2019

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The importance of quality critical reagents for the entire developmental lifecycle of a biopharmaceutical: a pharmacokinetic case study

Bioanalysis, 2021-05, Vol.13 (10), p.817-827

2021

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A Case Study for Critical Reagent Qualification for Ligand Binding Assays Using Equivalence Test Methodology

The AAPS journal, 2023-09, Vol.25 (5), p.89-89, Article 89

2023

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Best practices for the development, analytical validation and clinical implementation of flow cytometric methods for chimeric antigen receptor T cell analyses

Cytometry. Part B, Clinical cytometry, 2021-01, Vol.100 (1), p.79-91

2021

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Why is it important to develop a critical reagent management strategy?

Bioanalysis, 2021-07, Vol.13 (13), p.1025-1027

Maundrell, Naamah

2021

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EBF recommendation on practical management of critical reagents for PK ligand-binding assays

Bioanalysis, 2018-10, Vol.10 (19), p.1557-1565

2018

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Simple method to determine the concentration and incorporation ratio of ruthenium-labeled antibodies

Bioanalysis, 2022-01, Vol.14 (1), p.19-28

2022

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Critical reagents in flow cytometry, instrumentation and application in drug discovery development

Bioanalysis, 2021-05, Vol.13 (10), p.841-846

2021

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Capillary mediated vitrification is a novel technique that enables storage of antibody critical reagents at ambient temperature: Impact on binding, structure, and laboratory sustainability

Journal of pharmaceutical and biomedical analysis, 2024-12, Vol.251, p.116409, Article 116409

2024

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Critical reagent characterization and re-evaluation to ensure long-term stability: two case studies

Bioanalysis, 2021-05, Vol.13 (10), p.807-815

2021

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12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity

Bioanalysis, 2019-06, Vol.11 (12), p.1129-1138

2019

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Critical reagent screening and characterization: benefits and approaches for protein biomarker assays by hybrid LC–MS

Bioanalysis, 2019-04, Vol.11 (8), p.785-795

2019

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Critical reagents issues & solutions for anti-drug antibody assays

Bioanalysis, 2021-05, Vol.13 (10), p.779-786

Vermet, Laurent

2021

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Current and effective strategies for critical reagent characterization, storage, stability, retesting and life cycle management for ligand-binding assays and flow cytometry

Bioanalysis, 2021-05, Vol.13 (10), p.737-740

2021

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Lot-to-lot reproducibility, stability and life cycle management of antibody reagents for flow cytometry

Bioanalysis, 2021-05, Vol.13 (10), p.745-759

Lanham, David F

2021

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A systematic and sensitive method for critical reagent antibody evaluation with PCA technology

Bioanalysis, 2022-12, Vol.14 (23), p.1479-1486

2022

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Magnetic bead extraction with acid dissociation immunoassay for the determination of serum CD80-Fc fusion protein

Bioanalysis, 2021-01, Vol.13 (2), p.89-100

2021

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Critical reagent inventory management system and web portal specifically optimized for supporting external clients

Best practices on critical reagent characterization, qualification, and life cycle management for HCP immunoassays

Determination of label efficiency and label degree of critical reagents by LC-MS and native MS

Long term investigation of formulation buffers to mitigate stability issues of conjugated critical reagents

Critical reagents: evolution of WRIB recommendations on critical reagents

Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team

Ligand Binding Assays in the 21st Century Laboratory: Recommendations for Characterization and Supply of Critical Reagents

Monitoring CAR‐T cell kinetics in clinical trials by multiparametric flow cytometry: Benefits and challenges

EBF recommendation on practical management of critical reagents for antidrug antibody ligand-binding assays

The importance of quality critical reagents for the entire developmental lifecycle of a biopharmaceutical: a pharmacokinetic case study

A Case Study for Critical Reagent Qualification for Ligand Binding Assays Using Equivalence Test Methodology

Best practices for the development, analytical validation and clinical implementation of flow cytometric methods for chimeric antigen receptor T cell analyses

Why is it important to develop a critical reagent management strategy?

EBF recommendation on practical management of critical reagents for PK ligand-binding assays

Simple method to determine the concentration and incorporation ratio of ruthenium-labeled antibodies

Critical reagents in flow cytometry, instrumentation and application in drug discovery development

Capillary mediated vitrification is a novel technique that enables storage of antibody critical reagents at ambient temperature: Impact on binding, structure, and laboratory sustainability

Critical reagent characterization and re-evaluation to ensure long-term stability: two case studies

12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity

Critical reagent screening and characterization: benefits and approaches for protein biomarker assays by hybrid LC–MS

Critical reagents issues & solutions for anti-drug antibody assays

Current and effective strategies for critical reagent characterization, storage, stability, retesting and life cycle management for ligand-binding assays and flow cytometry

Lot-to-lot reproducibility, stability and life cycle management of antibody reagents for flow cytometry

A systematic and sensitive method for critical reagent antibody evaluation with PCA technology

Magnetic bead extraction with acid dissociation immunoassay for the determination of serum CD80-Fc fusion protein

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