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Dr. Afshin Safavi
Posted by Dr. Afshin Safavi BioAgilytix Insight, Biomarkers

The Challenges of Standardizing Commercial Kits for Biomarker Quantification in Drug Development: Part 1

The Challenges of Standardizing Commercial Kits for Biomarker Quantification in Drug Development: Part 1

Commercial immunoassay kits are an increasingly popular solution for pharmaceutical and biotechnology companies to expedite the drug development process during the discovery, preclinical and clinical study phases, and to rein in growing drug development costs in their organization. However, issues can arise when working with commercial immunoassay kits, because the way in which kit manufacturing companies characterize, describe, and market their kits is not standardized, and this can sometimes negatively impact the quality of the data produced. I believe that as an industry, we need to move towards a more systematic approach for the assessment, method adaptation, evaluation, and validation of commercial immunoassay kits for quantification of biomarkers in drug development. The end goal would be to specifically define these methods to standardize and harmonize as much as possible user practices, allowing scientists across the industry and around the world to better contribute to reliable biomarker data.

Addressing Drug Development Challenges with Biomarkers
The pharmaceutical and biotechnology industries are faced with various challenges in developing new and innovative medical products, including increased drug development costs, decreasing rate of drug approvals by the FDA, and on top of all that, the need to contend with the societal pressure to reduce healthcare costs that has come with healthcare reform legislation. In response, the FDA launched the Critical Path Initiative (CPI) with the goal to “stimulate and facilitate a national effort to modernize and streamline the scientific process through which a potential human drug or biological product is transformed from discovery or ‘proof of concept’ into an approved medical product.”

Part of streamlining the drug development process includes the use of biomarkers to combat the realities that the industry is facing. Biomarker data have been used to make decisions to improve safety and efficacy of potential drugs, as well as to guide decision making for personalized medicine throughout the drug development process. The potential benefits that biomarkers have to offer in this space have resulted in increased industry buy-in, but all of these potential decisions based on biomarker data can only be made with confidence when the quality of the data is consistently excellent. This is where harmonized practices become vital in producing high-quality data.

Why Commercial Kit Usage is On the Rise
Developing novel biomarker assays requires a great deal of time, a high level of expertise, and often comes at an incredibly high expense. These factors have contributed to the growing popularity of commercial immunoassay kits. Commercially available biomarker assay kits are a less resource-intensive alternative to support drug development programs at a lower price point. These kits also offer the benefits of portability, expedited analytical solutions, and in most cases, ease of operation.

However, not all kits are created equal. Remember that commercially available immunoassay kits are generally designed and marketed for broad applications across species, as well as variable matrices, rather than for specific applications in drug development clinical trials. Understanding this reality prompts knowledgeable scientists to specifically evaluate, select, adapt, and validate possible kits for drug development use so that they fit each study’s exact purpose.

This post is just the first in a series where I will discuss how to develop and follow a defined framework that can be used for standardizing the selection and validation process of commercial kit-based assays for your organization. This will involve discussion around defining the different types of immunoassay kits, and how to develop an appropriate method to use them. I will also share my opinions on choosing the appropriate kit and kit vendor. Finally, you’ll learn how to customize your kit through method adaptation and validation.

Check back weekly to learn more about our process recommendations and how they can provide higher quality data to positively impact the development of new, much needed biotherapeutics.

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