Addressing the challenges of biomarker calibration standards in ligand-binding assays: a European Bioanalysis Forum perspective-Reference-Cited by-同舟云学术

Addressing the challenges of biomarker calibration standards in ligand-binding assays: a European Bioanalysis Forum perspective

Published:2017-10 Issue:19 Volume:9 Page:1493-1508
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Kunz Ulrich¹,Goodman Joanne²,Loevgren Ulf³,Piironen Timo⁴,Elsby Karen⁵,Robinson Paul⁶,Pihl Susanne⁷,Versteilen Amanda⁸,Companjen Arjen⁸,Fjording Marianne Scheel⁹,Timmerman Philip¹⁰

Affiliation:

1. Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Strasse 65, 88397 Biberach an der Riss, Germany

2. MedImmune, Aaron Klug Building, Granta Park, Cambridge, CB21 6GH, UK

3. Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, DK-2300 Copenhagen S, Denmark

4. Syrinx Bioanalytics Oy, Pansiontie 47, Biohouse D5, FI-20210 Turku, Finland

5. AstraZeneca R&D Alderley Park, Macclesfield, Cheshire, UK

6. LGC Ltd, CB7 5WW, UK

7. Ascendis Pharma A/S, Tuborg Boulevard 5, 2900 Hellerup, Denmark

8. Janssen Vaccines & Prevention B.V., Fakkelgras 10, 2224JT Katwijk, The Netherlands

9. NovoNordisk A/S, Novo Nordisk Park, DK-2760 Måløv, Denmark

10. European Bioanalysis Forum, Belgium

Abstract

The analysis of biomarkers by ligand-binding assays offers significant challenges compared with the bioanalysis of small and large molecule drugs. The presence of endogenous analyte is a commonly cited issue. Also the sourcing and application of appropriate calibration or reference standards can present many issues. One of the main challenges is ensuring the continuity and validity of biomarker data when the source or lot number of calibration standard changes within or between studies. Several strategies exist in attempting to deal with this and standardize the biomarker data through the assay life or looking for ways to compare and normalize biomarker data. In this manuscript, the European Bioanalysis Forum view on dealing with calibration standards in biomarker assays is described.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio-2017-0141

Reference18 articles.

1. Standardization and Calibration

2. Approach to maintaining comparability of biochemical data during long-term clinical trials

3. European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development

4. Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development

Cited by 6 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Overcoming Lot-to-Lot Variability in Protein Activity Using Epitope-Specific Calibration-Free Concentration Analysis;Analytical Chemistry;2024-04-11

2. Biomarker Assay Validation by Mass Spectrometry;The AAPS Journal;2022-05

3. Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?;The AAPS Journal;2022-05

4. Calibrator material selection: a key criteria during biomarker assay method development;Bioanalysis;2021-05

5. Update to the European Bioanalysis Forum recommendation on biomarkers assays; bringing context of use into practice;Bioanalysis;2020-10