Impact of ELISA Immunoassay Development and Validation in Bioanalytical Laboratories
With a decrease in R&D returns and an increase in manufacturing costs for drug products, sponsors must diligently assess the drug discovery and development process. Immunoassay development and validation are one such processes that can guarantee the timely delivery of high-quality drug data. Speed and high-quality results are crucial for any bioanalytical development. While traditional ELISAs have been the gold standard in the drug development life cycle, automated bioanalytical services are the key to accelerating drug development timelines.
Matrix effects, data quality, inconsistent bioanalytical method and reagents, and time-consuming ELISA method development are primary challenges faced while using ligand binding assays. Hence, a well-developed approach with adequate method validation of an ELISA assay will significantly impact the conduct of bioanalytical laboratories. This article addresses some of these impacts of immunoassay development and validation on laboratories such as ELISA services and CROs.
ELISA immunoassay development and validation for bioanalytical laboratories
A robust bioanalytical approach is vital for drug discovery and development. A successful strategy establishes drug-target interaction, provides early safety data, identifies safe drug doses, and assists clinical trial designs. Hence, bioanalytical laboratories have developed a fit-for-purpose approach for ELISA method validation. This approach ensures that the developed assay meets the required acceptance criteria for its intended use in drug development. An ideal fit-for-purpose assay should provide precise and accurate measurements of analytes in biological samples. Besides, they should be highly selective and sensitive in analysis. Not to mention, the assay should produce reliable results every time the assay is used for analysis.
Immunoassay development and validation have forced laboratories to minimize errors in bioanalysis. Laboratories limit mistakes by reducing pipetting errors and placing samples in the correct wells. They have simplified the ELISA protocol as much as possible to reduce experimental errors. Today several laboratories employ automation to replace manual operations and reduce human errors. Besides, the advent of fit-for-purpose assays has reduced the developmental costs in drug development. However, several factors are involved in efficient method development, validation, and conduct of ELISA assays.
Immunoassay development and validation is a time-consuming yet crucial deciding factor in the success of a drug development project. Hence, sponsors often consider a ready-to-use ELISA kit that is verified, validated, and assessed through quality controls for high-quality results. Some sponsors also consider detailed information of assay development provided by a manufacturer that minimizes the extent of method development. If such kits are not available, bioanalytical laboratories carefully select a suitable immunoassay platform with very few variables for the rapid development of ELISA assays.
Furthermore, bioanalytical laboratories employ high-throughput platforms to reduce the assay’s turnaround time and give additional time for other vital tasks such as in-house research and data analysis. Besides, the accuracy, robustness, precision, and broad dynamic range from automated systems minimize the need for re-runs and provide parallel analysis of study data.
Conclusion
Immunoassay development and validation form a significant part of a drug discovery and development project. Hence, adequate development and validation of ELISA assays will help bioanalytical laboratories provide accurate and high-quality data to sponsors and regulatory submissions.
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