Potency Assay Services
We develop, qualify, and validate mechanism-driven potency assays for gene therapies and ATMPs across the entire development lifecycle.
Potency assays for gene therapies and ATMPs rarely behave ideally. Biological systems introduce variability that cannot be eliminated — only understood and managed. We design and execute potency assays that remain robust under real biological conditions:
- Non-ideal dose-response behavior
- Batch-to-batch variability
- Low transduction efficiency
Our approach ensures that potency readouts remain reliable, reproducible, and scientifically meaningful — even when biology is challenging.
Reduce your regulatory risk
With assays designed for regulator acceptance from day one.
Avoid late-stage assay redesign
With GMP constraints, robustness, statistical models and references standards all considered early in development.
Save time across the lifecycle
Through early identification of biological variability and assay limitations — enabling robust development and a smoother progression.
Minimize dead ends
We help clients anticipate biological and statistical challenges, and provide expert support when batch-to-batch variability or unexpected assay behavior occurs.
Reduce your regulatory risk
With assays designed for regulator acceptance from day one.
Avoid late-stage assay redesign
With GMP constraints, robustness, statistical models and references standards all considered early in development.
Save time across the lifecycle
Through early identification of biological variability and assay limitations — enabling robust development and a smoother progression.
Minimize dead ends
We help clients anticipate biological and statistical challenges, and provide expert support when batch-to-batch variability or unexpected assay behavior occurs.
Achieving precision with cell-based potency assays
In the below example, cells were transduced across a range of MOI, and supernatants tested for protein activity (colorimetric assay).
Transduction signal increases with MOI, generating the characteristic sigmoidal dose–response shape comprising a lower asymptote, linear range, and upper asymptote. Reference and test samples overlay closely across the MOI range, demonstrating consistent assay performance and robust transduction.
Triplicate measurements at each MOI demonstrate excellent precision, with low intra‑assay variability.
| MOI | Average % CV of triplicates |
|---|---|
| 8.40E+05 | 6.1 |
| 4.20E+05 | 6.0 |
| 1.05E+05 | 4.2 |
| 3.50E+04 | 4.4 |
| 1.17E+04 | 6.0 |
| 2.33E+03 | 10.0 |
| 4.67E+02 | 10.3 |
| 9.33E+01 | 14.9 |
Our validated assays typically demonstrate low intermediate precision variability, with operator‑to‑operator and day‑to‑day differences remaining tightly controlled
6% CV
(Validation MOI 1.17E+04)
What makes Ascend different?
Operational Excellence
Highly trained operators with deep assay understanding and real-time troubleshooting capability. The same experts who develop the assay execute it under GMP — ensuring full continuity and no loss of knowledge.
Scientific Depth
Extensive experience in complex potency assays and systems with inherent biological variability.
Supported by advanced statistical expertise (full-curve and linear-range PLA, factor-to-reference approaches).
Strategic Understanding
Deep regulatory experience across clinical phases enables phase-appropriate potency strategies and ensures GMP readiness from early development. Built on a developer mindset, with a clear understanding of program risk and long-term assay scalability.
Operational Excellence
Highly trained operators with deep assay understanding and real-time troubleshooting capability. The same experts who develop the assay execute it under GMP — ensuring full continuity and no loss of knowledge.
Scientific Depth
Extensive experience in complex potency assays and systems with inherent biological variability.
Supported by advanced statistical expertise (full-curve and linear-range PLA, factor-to-reference approaches).
Strategic Understanding
Deep regulatory experience across clinical phases enables phase-appropriate potency strategies and ensures GMP readiness from early development. Built on a developer mindset, with a clear understanding of program risk and long-term assay scalability.
Potency Assay Service Overview
Assay Strategy & Development
Potency assay design grounded in the biology of your therapeutic, including:
- Mechanism‑driven assay concepts tailored to your product
- Selection and evaluation of physiologically relevant cell models
- Development of functional readouts aligned with your mode of action
- Thoughtful reference standard strategy to enable long‑term comparability
- Flexible statistical approaches that best fits your assay biology, material availability, and development stage.
Deliverable:
- A scientifically sound assay that is fit for purpose
Non‑GMP Qualification
To ensure the assay is reliable and fit for early‑phase use.
Deliverables:
- Qualified, phase‑appropriate potency assay
- A comprehensive qualification report
ICH-Compliant GMP Validation
For later clinical phases and regulatory submission, we execute full method validation aligned with ICH guidelines.
Deliverable:
- A complete validation package ready for regulatory filing
Life Cycle Support
We support your overall potency assurance strategy, through assay implementation and ongoing commercial readiness with:
- Seamless transfer into the GMP environment
- SOP creation and analyst training
- Reference standard management
- Assay trending and monitoring
- Post‑approval lifecycle support
- Comparability strategies to maintain product consistency
Ready to speak to a member of the team about your potency assay requirements?
Please contact us using the form below.
Potency Assay Form
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