Cell-based bioassays for the functional evaluation of biologics
We develop and perform cell-based bioassays to evaluate the biological activity, potency, and mechanism of action of biologic products, generating relevant functional data for development, comparability, and control purposes.
- Potency assays
- Functionality and mechanism of action assays
- Potency and functionality assays
- Method development, transfer, and validation
Each study is designed according to the molecule’s mechanism of action, integrating functional results with other analytical strategies to better characterize the product’s biological behavior.
The cellular models used allow us to measure relevant biological responses and support studies on potency, comparability, change control, and batch release.
We design assays aligned with the biological relevance of the product to assess potency, consistency, and activity in complex molecules and programs with specific analytical needs.
What are cell-based bioassays?
Cell-based bioassays are in vitro assays that use living cells to measure the biological response to a drug, allowing direct evaluation of its:
- Biological potency
- Functional activity
- Mechanism of action (MoA)
- Interaction with the cellular target
The challenge of cell-based bioassays
Poorly optimized assays can generate variability and non-comparable results. Functional evaluation of biologics requires:
- Robust and well-characterized cellular systems
- Controlled experimental conditions
- Reproducible methods across assays and batches
- Specific and quantitative readouts
Integrated cell culture platform
At Netpharmalab, we have a cell culture laboratory with BSL-2 infrastructure, equipped with:
- Biosafety cabinets
- CO₂ incubators
- Monitoring and control systems
- Standard operating procedures (SOPs)
What does our cell-based bioassay service include?
1. Cell culture facilities
- Handling of adherent and suspension cell lines
- Establishment of reporter cell lines (luciferase, fluorescence)
- Cell culture maintenance and control
- Evaluation of morphology, viability, and cell density
2. Cell-based functional bioassays
Design and execution of assays adapted to the biologic’s mechanism of action:
- Potency assays (proliferation, inhibition, apoptosis, signaling)
- Reporter gene assays (luciferase, fluorescence)
- Immune response assays (cytokine release)
- Receptor-mediated binding and internalization assays
3. Main applications
- Batch release and biological potency control
- Mechanism of action (MoA) studies
- Batch and biosimilar comparability
- Stability studies with functional readouts
- Process change evaluation
4. Bioassay development, transfer, and validation
We provide full support across the bioassay lifecycle:
- Development from concept or preliminary protocol
- Method transfer from the client
- Optimization of critical conditions
- Method qualification and validation
Parameters evaluated:
- Precision
- Linearity
- Range
- Robustness
- Intra-/inter-day variability
Technologies and capabilities
- Controlled-environment cell culture platforms
- Reporter systems (luciferase, fluorescence)
- In vitro functional assays
- Quantitative and reproducible readouts
Regulatory compliance and quality
Our bioassays comply with:
- EMA (European Medicines Agency)
- FDA (Food and Drug Administration)
- BSL-2 environments
- ALCOA+ data integrity principles
- Complete SOPs and qualified equipment (IQ/OQ)
Frequently Asked Questions (FAQ)
- What is the difference between a cell-based bioassay and an analytical assay?: Cell-based bioassays measure the functional activity of the drug, while analytical assays evaluate its structure or composition.
- What types of products can be evaluated?: Monoclonal antibodies, recombinant proteins, oligonucleotides, viral vectors, and other biologics.
- What is a potency assay?: It is an assay that measures the ability of a drug to produce a specific biological effect.
- Can assays be adapted to the mechanism of action?: Yes, bioassays are specifically designed based on the product’s MoA.
- Are these assays required for registration?: Yes, functional bioassays are critical for quality control, batch release, and regulatory development.
Request more information about our biologics testing services
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