Assay Development & Validation

Custom assay development is essential for addressing unique research, diagnostic, and clinical questions. At WaveCyte BioLabs, we specialize in designing, developing, qualifying, and validating bespoke bioanalytical assays to meet the specific needs of all stages of drug development

Our Custom Assay Services

• Cell-Based Assays: Functional characterization of cells, including proliferation, cytotoxicity, and receptor activation.

• ELISA and Cytokine Multiplexing: Single and multi-analyte quantification with high sensitivity and specificity.

• Molecular Assays: PCR/RT-PCR, next-generation sequencing (NGS), and nucleic acid quantification.

• Flow Cytometry-Based Assays: Phenotypic and functional analyses of cells in complex samples.

• Reporter Gene Assays: Quantifying transcriptional activity or gene expression.

• Receptor Phosphorylation & Toxin Neutralization Assays: Evaluating signaling pathways and neutralization potential.

• Luminescence and Fluorescence Technologies

Our Process

Collaborative Design

We begin by working closely with your team to understand your objectives and customize the assay to suit your specific needs.

Assay Development

• Selection of the most appropriate assay format and reagents.

• Integration of advanced platforms such as luminescence, fluorescence, and 3D cell culture systems.

Assay Validation

• Thorough qualification and validation to ensure compliance with regulatory standards (GLP, ICH guidelines, and 21 CFR Part 11).

• Validation of accuracy, precision, sensitivity, specificity, and robustness.

Automation and High-Throughput Solutions

We offer assay automation solutions using high-throughput platforms to enhance reproducibility and efficiency.

Statistical Optimization

• Integration of statistical design of experiments (DOE) to optimize assay robustness.

• Advanced data analytics to ensure consistent and reliable outcomes.

Robust, reproducible results at every stage of drug development. Specializing in cell-based assays, ELISA, and qPCR/RT-PCR, we utilize high-throughput automation and advanced 3D cell culture models. Adhering to stringent regulatory standards (GLP, ICH, 21 CFR Part 11), we deliver precise, actionable data to accelerate your drug pipeline with confidence.

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