Cell-Based Assays in Drug Development

CMIC Chicago Laboratory Cell-Based Assay Services

What are cell-based assays?

Cell-based assays are essential in bioanalytical drug development, offering invaluable tools to assess the efficacy, safety, and pharmacological properties of therapeutic candidates. These assays use living cells as functional units to mimic physiological responses, providing a biologically relevant assessment of drug activity. By investigating various biological processes, these assays can assess drug efficacy and examine mechanisms at the cellular level.

Key Benefits of Cell-Based Assays

  • Biological Relevance: Provides a realistic assessment of drug activity.
  • Versatility: Can be tailored to specific mechanisms of action.
  • Safety and Efficacy Assessment: Crucial for evaluating potential therapeutic candidates.

Our experts at CMIC have expertise with many different types of mammalian cell lines, both adherent and suspension. Assay performance is directly dependent on cell line performance. Our experience with multiple cell lines is an asset in ensuring well performing assays that are reproducible. Proper aseptic technique is crucial for proper maintenance and propagation of cells. By adhering to strict aseptic techniques, we maintain the validity of experimental results and uphold the highest standards of quality. These factors help limit variability in cell-based assays and produce consistent assay results.

Molecules under microscope

Capabilities

We have the knowledge and experience to develop or transfer cell-based assays based on the drug’s mechanism of action. Our capabilities include:

  • Absorbance, Luminescence, and Fluorescence: Utilizing Tecan, SpectraMax, and MSD plate readers.
  • Time-Resolved Fluorescence and Electrochemiluminescence (ECL): Advanced techniques for accurate results.
  • Immunogenicity Assays: Expertise in ADA and NAb assays, making CMIC the ideal partner for immunogenicity work

Cell-based Assays at CMIC Inc.

Neutralizing Antibody Assays (NAb)

Neutralizing antibody assays determine whether antibodies impact drug functionality. Often, a cell-based assay is required for this purpose. CMIC’s scientists have extensive experience in:

  • Development and Validation: Creating precise and sensitive cell-based assays.
  • Drug Tolerance Issues: Addressing and improving drug tolerance.
  • Regulatory Requirements: Understanding and meeting regulatory demands, especially in late-phase clinical trials.

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