Technology Digest: effective biomarker measurement is key for biotherapeutic development

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Biomarkers and their role in drug development

A hybrid of the word ‘biological marker’, biomarkers are a biologic or physiological characteristic that can act as a measurement of either normal or pathogenic biological processes or responses to a therapeutic/intervention [1]. Biomarkers can thus be utilized as important tools for disease diagnosis, prognosis and prediction, as well as an indicator of drug safety and efficacy [1,2].

When utilizing biomarkers in the drug development process, their fit-for-purpose validation is essential in ensuring that the biomarker effectively reveals the targeted outcome and that the characteristics used to assess biomarker assay performance are purposeful. Biomarkers have been identified as a critical player in the progress towards personalized or patient-centered medicine, tailoring therapeutics and drugs to a specific patient’s needs [2]. Proper clinical and analytical validation of biomarkers relies on carefully considering aspects such as reference standard sourcing, instrumentation, sample preparation strategies and matrix interference in biological matrices [2,3].

Download the eBook to continue reading and to learn more about biomarker measurement.

This eBook includes:

  • EDITORIAL: Evolving our thinking on biomarker assay validation: are we ready for the next leap?
  • POSTER: Extended sensitivity of microfluidic immunoassays for pharmacokinetic (PK) and biomarker analysis
  • PERSPECTIVE: Accelerating protein biomarker discovery and translation from proteomics research for clinical utility

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References

  1. Strimbu K, Tavel JA. What are biomarkers? Curr. Opin. HIV AIDS. 5(6), 463–466 (2010).
  2. Yu C, Bashaw ED. Regulatory perspective of biomarker bioanalysis during drug development. Bioanalysis, 11(7), 607–610 (2019).
  3. Taube SE, Clark GM, Dancey JE, McShane LM, Sigman CC, Gutman SI. A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment. J. Natl. Cancer Inst. 101(21), 1453–1463 (2009).

This feature has been brought to you in association with Gyros Protein Technologies. The opinions expressed in this feature are those of the author and do not necessarily reflect the views of Bioanalysis Zone or Future Science Group. 

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