Introduction
cost-effective solutions or a pharma company scaling complex workflows, we provide the expertise to move your science forward.
What is Assay Development?
Assay development is the process of designing and optimising tests that measure biological activity, compound potency, or target engagement. A well-developed assay provides the foundation for screening, lead optimisation, and decision-making throughout the drug development pipeline.
Why Validation Matters
Validation confirms that your assay performs consistently and accurately under defined conditions. It reduces risk, supports your discovery and development goals, and progresses through regulatory submissions, ensuring confidence in your data.
Our validation protocols align with FDA and EMA guidelines, providing high quality, reproducible data throughout all clinical phases , allowing your teams to continue with data analysis progressing your clinical trial.
Assay Formats
Cell-based, Immunology, Serology, Enzyme, ELISA, Multiplexed binding, Molecular Biology, Drug Potency
Platforms
ELISA, MSD, ELISpot, ddPCR QX700, Multiplex Cytokine Profiling MSD, NGS Illumina and DRAGEN pipeline, ddPCR, CTL Bacterial colony counter
Customisation
Regulatory Alignment
How hVIVO Can Solve Your Challenges
Our in-house team of cross-functional experts including consultancy, science, and laboratory operations will work with you on:
- Consultation & Design aspects
- Optimisation & Development
- Validation & Documentation
- Ongoing Support
Custom Assay Design: Where Scientific Creativity Meets Regulatory Precision
Drug developers working in infectious diseases, oncology, autoimmune and advance modalities like cell and gene therapy, ADCs, RNA therapeutics (mRNA/RNAi) increasingly face a familiar challenge: the assays they need often don’t yet exist. Off‑the‑shelf solutions rarely answer the specific mechanistic questions regulators ask, and standard diagnostic platforms offer little room for adaptation. As therapeutics become more complex, the tools required to evaluate them must evolve just as quickly. That’s where custom assay design becomes essential. It’s not simply a technical exercise — it’s a form of scientific problem‑solving that blends creativity, regulatory awareness, and deep understanding of the mechanism of action. And it’s becoming one of the most important ways to de‑risk early‑phase development.