Potency assays
According to ICH Q6B, potency is the quantitative measure of a product’s biological activity, determined through a validated bioassay that reflects its mechanism of action.
Measuring the biological activity of your product with confidence
Potency assays, also known as bioassays, are essential throughout the development of biopharmaceutical products. They bridge the gap between a product’s analytical characterisation and its actual biological effect, providing the functional evidence of its efficacy. From early-stage studies to GMP compliant batch release testing, these assays ensure product consistency and integrity over time.
At Quality Assistance, we design, validate and execute potency assays that are tailored to your product’s mode of action and compliant with EMA and FDA expectations, giving you full confidence in your critical analytical decisions.
Analytical challenges we solve
Defining biological potency requires both precision and experience. Each molecule interacts differently with its target, meaning there is no “one-size-fits-all” approach. At Quality Assistance, we help you:
- Select a relevant model reflecting your product’s mechanism of action
- Design assays that remain robust despite biological variability
- Correlate potency with your product quality attributes
- Choose the appropriate read-out system (binding vs. functional)
- Validate methods according to international guidelines (ICH Q2(R2), Q14, USP <1033>)
- Ensure long-term consistency across GMP release and stability testing via method lifecycle management
Our teams apply a pragmatic and phase appropriate Quality by Design (QbD) approach, working collaboratively with you to define the Analytical Target Profile to ensure assay relevance, precision and robustness aligned with your development strategy.
Our approach to potency testing
We provide end-to-end support for potency assay development, from method design to routine use, in full compliance with ICH and USP guidance.
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Development and optimisation
- Custom assay design reflecting your product’s mechanism of action
- Risk-based identification of critical parameters
- Collaborative definition of assay acceptance criteria
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Method transfer
- Transfer from your laboratories or third-party labs under a defined protocol
- Optimisation of your existing assays within our GMP-compliant environment
- On-site training for seamless knowledge continuity
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Validation and routine use
- Validation under ICH Q2(R2) and USP <1033> for bioassays
- Preparation of regulatory-compliant protocols and reports
- Application to GMP batch release and stability testing
- Statistical trending for continuous performance monitoring
Two complementary approaches: Ligand-Binding and Cell-Based Assays
Because biological activity can be seen from different angles, we combine ligand-binding assays (LBA) and cell-based assays to capture a complete picture of your product’s potency.
Technologies and analytical environment
Our potency testing capabilities combine cutting-edge technologies with secure digital data management systems.
From binding kinetics to cell response quantification, all assays are developed under GMP-compliant environment, validated according to ICH and USP guidelines and performed across 4 dedicated in-house laboratories, for a total of 22 workstations.
Download our technical sheet to explore our full capabilities
Why innovators choose Quality Assistance
Partnering with us means working with an analytical CRO that understands your scientific and strategic priorities. What we offer:
- Comprehensive capacity: dedicated GMP-compliant bioassay labs
- Integrated expertise: from method development to batch release, on one site
- Regulatory understanding: assays validated in line with EMA/FDA expectations, compliant with ICH Q2(R2), Q6B, Q14, and USP <1033>
- Tailored partnership: collaborative assay design aligned with your product’s mode of action
- Strategic guidance: assays built for comparability, release and stability, with sound performance criteria (ATP)
- Data integrity: secured systems, full traceability and continuous performance trending
Ready to discuss your potency testing strategy?
Our experts help you define and validate potency assays that accurately reflect your product’s mechanism of action, ensuring regulatory compliance and accelerating your path to patients.