Development and Validation of Ligand‐Binding Assays for Biomarkers

Lee, Jean W.; Pan, Mengqi; O’Brien, Peter J.; Sc, M

doi:10.1002/9780470541517.ch6

Cited by 5 publications

(6 citation statements)

References 25 publications

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“…The rough category of exploratory or advanced application is a wide spectrum that demands flexibility in method validation rigor. Appropriate experiments should be carried out on sample collection, relative accuracy, precision, range finding, parallelism, selectivity, specificity and stability [20]. Biomarker bioanalysis and method validation are continuous processes for accumulating knowledge through the development of inter-related biomarkers and understanding protein-protein interactions of biomarkers and biotherapeutics of similar mechanisms.…”

Section: Reproducibility Demonstrated By Incurred Sample or Sample Comentioning

confidence: 99%

“…It is necessary to select the potential biomarkers and the corresponding biological matrix, define the intended purpose and decide the type of method validation that suits the application. A work plan may be used to clarify the purpose and lay out the experiments to be conducted [20]. Stability of the analytes in stock solution and biological matrix during the processes of sample collection, storage, shipping, freezing/thawing and throughout the last assay should be evaluated for drug compounds and biomarkers [21].…”

Section: Pre-analytic Considerations That Impact Biomarker Ana Lysismentioning

confidence: 99%

“…Then, the reference material is spiked into each matrix lot, at a level comparable to that of the basal concentration. The spike concentration cannot be substantially lower than the baseline and the spiked volume should not exceed 5% of the individual matrix volume [20]. Spike recovery is calculated after subtraction of the basal value and compared with the nominal spike concentration or the mean of the test lots.…”

Section: Standard Calibrator Matrix and Selectivity: Matrix Effect Mattmentioning

confidence: 99%

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Method Validation and Application of Protein Biomarkers: Basic Similarities and Differences from Biotherapeutics

Lee

2009

Bioanalysis

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Protein drug development and biomarkers share common bioanalytical technologies that are applied for different purposes. A fit-for-purpose approach should be used for biomarker assays at various stages of novel biomarker development and their application to drug development. Biomarker quantifications can be absolute or relative, depending upon the characteristics of the standard curve, which include the reference standard, substituted matrix and parallelism. Appropriate method-validation experiments should be carried out on sample collection, relative accuracy and precision, range finding, parallelism, selectivity, specificity and stability in order to meet the need for exploratory or advanced application that is specified for a study. The interaction of a biotherapeutic with the target ligand or inter-related biomarkers should be taken into consideration for method platform choice and validation. Direct adoption of commercial diagnostic kits can produce confounding data. Therefore, kit comparison, modification and appropriate validation experiments are often carried out to meet the specific purpose for drug development. Multiplex assays and physicochemical methods can complement the single-analyte ligand-binding assay for protein drugs and biomarkers.

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Section: Reproducibility Demonstrated By Incurred Sample or Sample Comentioning

confidence: 99%

Section: Pre-analytic Considerations That Impact Biomarker Ana Lysismentioning

confidence: 99%

Section: Standard Calibrator Matrix and Selectivity: Matrix Effect Mattmentioning

confidence: 99%

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Method Validation and Application of Protein Biomarkers: Basic Similarities and Differences from Biotherapeutics

Lee

2009

Bioanalysis

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“…Signal suppression from plasma binding proteins often occurs, resulting in a negative bias. Since health status and collection conditions may lead to variability of binding protein types and levels, selectivity tests should be conducted on several individual lots from the target population against the calibrators that are prepared in a protein-buffer or a single matrix pool [27,93,94].…”

Section: Selectivity Testsmentioning

confidence: 99%

Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis☆

Lee

Hall

2009

Journal of Chromatography B

Self Cite

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“…Assay validation requires the selection of the intended biological matrix, including the potential effects of interfering substances and dilution. Evaluations for assay validation include (1) accuracy, (2) calibration curve, (3) precision, (4) total error, (5) lower and upper level of quantification (LLOQ and ULOQ, respectively) to determine assay range (LLOQ ‐ ULOQ), (6) sensitivity, (7) limit of detection (LOD), (8) dynamic range (range of linearity), (9) specificity, and (10) analyte stability …”

Section: Summary Of Best Practice Recommendationsmentioning

confidence: 99%

Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries

Tomlinson

Boone

Ramaiah

et al. 2013

Veterinary Clinical Pathol

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The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines) and published recommendations for best practices in veterinary toxicologic clinical pathology, particularly in the pharmaceutical and biotechnology industries, and to utilize the combined experience of ASVCP RAC to provide updated recommendations. Discussion points include (1) instrumentation, validation, and sample collection, (2) routine laboratory variables, (3) cytologic laboratory variables, (4) data interpretation and reporting (including peer review, reference intervals and statistics), and (5) roles and responsibilities of clinical pathologists and laboratory personnel. Revision and improvement of current practices should be in alignment with evolving regulatory guidance documents, new technology, and expanding understanding and utility of clinical pathology. These recommendations provide a contemporary guide for the refinement of veterinary toxicologic clinical pathology best practices.

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Development and Validation of Ligand‐Binding Assays for Biomarkers

Cited by 5 publications

References 25 publications

Method Validation and Application of Protein Biomarkers: Basic Similarities and Differences from Biotherapeutics

Method Validation and Application of Protein Biomarkers: Basic Similarities and Differences from Biotherapeutics

Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis☆

Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries

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