Recommendations for Selection and Characterization of Protein Biomarker Assay Calibrator Material

Cowan, Kyra J.; Amaravadi, Lakshmi; Cameron, Mark J.; Fink, Damien; Jani, Darshana; Kamat, Medha; King, Lindsay; Neely, Robert; Yan, Ni; Rhyne, Paul; Riffon, Renée; Zhu, Yuda

doi:10.1208/s12248-017-0146-9

Cited by 17 publications

(8 citation statements)

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“…Key concepts related to biomarker assay development at various phases of drug development include an understanding of the reference standard characterization required (when NIST, WHO or USP standards are not available); understanding the difference between endogenous biomarkers and the calibrator material used in assays; key parameters such as parallelism, relative accuracy, precision, stability, sample integrity; and finally, the use and interpretation of biomarker data (qualitative, relative quantitative versus quantitative) -among others [44].…”

Section: Level Of Validation Required For Biomarkers That Are Not Part Of the C-path White Papermentioning

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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Section: Level Of Validation Required For Biomarkers That Are Not Part Of the C-path White Papermentioning

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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“…LBA biomarker assays are typically not absolute quantitation; however, they are relative quantitation to the calibrator material being utilized. Therefore, where possible effort must be made to select calibrator material that represents the endogenous form of the analyte [5]. Also, reagent antibodies must be selected for their ability to not just bind calibrator material but also endogenous material.…”

Section: Charting the Path On Biomarker Assay Methods Developmentmentioning

confidence: 99%

Exploratory Biomarker Assays: Key Assay Parameters to Evaluate in the Face of Evolving Biomarker Context-of-Use

Thankamony

Zhang

2019

Bioanalysis

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“…In most quantitative biomarker assays, the calibrator material is usually not equivalent to the endogenous analyte of interest. There may be no reference standard such as a WHO standard and even when such a standard is available, there can be variation between the batches that needs to be carefully controlled [18,19]. Therefore, most quantitative biomarker assays where the calibrator curve may be well-defined will fall into the relative quantitative category.…”

Section: Types Of Bm Assaysmentioning

confidence: 99%

Update to the European Bioanalysis Forum Recommendation on Biomarkers Assays; Bringing Context of Use Into Practice

et al. 2020

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In 2012, the European Bioanalysis Forum published a recommendation on biomarker method development and the bioanalysis of biomarkers in support of drug development. Since then, there has been significant discussion on how to bring the topic of context of use of biomarker assays to the forefront so that the purpose of the assay, the use of the data and the decisions being made with the data are well defined and clearly understood, not just by the bioanalytical scientist, but across all stakeholders. Therefore, it is imperative that discussions between the bioanalytical laboratory and the end users of the data happen early (and regularly) in the drug development process to enable the right assays to be developed and appropriately validated to generate the correct data and allow suitable decisions to be made. This updated refinement to the previous European Bioanalysis Forum recommendation will highlight the items to consider when discussing context of use for biomarker assay development and validation, thus enabling the correct conversations to occur and the move away from the misapplication of PK assay validation criteria to biomarker assays.

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Recommendations for Selection and Characterization of Protein Biomarker Assay Calibrator Material

Cited by 17 publications

References 32 publications

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)

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)

Exploratory Biomarker Assays: Key Assay Parameters to Evaluate in the Face of Evolving Biomarker Context-of-Use

Update to the European Bioanalysis Forum Recommendation on Biomarkers Assays; Bringing Context of Use Into Practice

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