𧬠Cell-Based Assay Development for Potency and Drug Screening β‘
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Cell-based assays are powerful tools inΒ drug discovery, potency testing, and therapeutic evaluation. Unlike biochemical assays that only measure isolated interactions, these assays mimic the cellular environment β providing a more accurate reflection of how a drug behaves in living systems. π±
π What are Cell-Based Assays?
Cell-based assays use living cells to assess the biological activity of compounds, antibodies, or biologics. They capture cellular responses such as proliferation, cytotoxicity, apoptosis, receptor binding, or signaling pathway activation. These responses give researchers insights into drug efficacy and safety before clinical testing. π
π§ͺ Steps in Cell Assay Development
- π Define the Objective β Identify whether the assay is for potency testing, biomarker readout, or mechanism-of-action studies.
- π Choose the Right Cell Line β Select primary cells or immortalized cell lines relevant to the target biology.
- π Assay Design β Decide between reporter assays, viability assays, or functional readouts (e.g., calcium flux, cytokine release).
- π Optimization β Adjust seeding density, incubation times, and detection reagents to maximize sensitivity and reproducibility. βοΈ
- π Validation β Perform precision, accuracy, specificity, and robustness testing to meet regulatory expectations.
π‘ Applications in Drug Screening
- πΉ High-Throughput Screening (HTS) β Rapidly screens thousands of compounds for biological activity.
- πΉ Potency Assays β Measures drug activity against a defined standard to ensure consistency.
- πΉ Mechanistic Studies β Helps in understanding how drugs modulate pathways or targets inside cells.
- πΉ Biologics Evaluation β Essential for antibody, CAR-T, and cell therapy potency testing. π§ͺ
π Advantages of Cell-Based Assays
βοΈ Physiologically relevant results
βοΈ Ability to capture complex signaling events
βοΈ Flexible design for multiple drug classes
βοΈ Direct link to clinical relevance
π Future of Cell Assay Development
With the rise of 3D cell culture, organoids, and CRISPR-edited models, cell-based assays are becoming more predictive and personalized. This evolution will enhance precision medicine and accelerate safe drug approvals. π§¬β¨
π Related Reading: π Assay Development (Pillar) | π Biomarker Assay Development