Bioassays – Custom Potency Testing, Validation & Assay Transfer
We develop and produce customized Functional Bioassays to precisely evaluate the biological activity, efficacy, or neutralization capacity of drug substances, vaccines, or diagnostics. We combine cell-based and bacterial systems with validated detection methods according to ISO 13485 standards – tailored to your specific research questions.
Whether for research, clinical development, or IVDR-compliant quality control – we support you with validated assays, method transfer, and application-specific expertise.
Our Bioassay Platforms Include
- Coupling of mammalian cells – for specific detection or neutralization assays
- Coupling of bacterial strains (e.g., lactic acid bacteria) – for targeted immune responses or activity testing
Do you need additional quantitative data to evaluate your bioassay results? Our Study Sample Analysis provides precise measurements for a reliable assessment of your study samples.
Your Benefits with ASKA's Bioassay Development
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Certified to ISO 13485 – Your guarantee for top-tier quality and full IVDR compliance.
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Flexible customization – tailored to your target cells, mechanisms, and test formats
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Fast implementation – short development timelines from concept to functional assay
Our Services in Bioassay Development
- Feasibility Studies & Assay Design: Assessment of technical feasibility and development of a suitable functional test concept
- Cell & Strain Selection: Selection and cultivation of suitable mammalian cells or bacterial strains – tailored to your application
- Assay Development & Validation: Establishment of functional bioassays with defined parameters and standardized readouts
- Optimization & Scaling: Adjustment of test conditions for maximum reproducibility – including high-throughput adaptation
- Technology Transfer: Transfer of bioassays into your lab systems – including documentation and training
Your Bioassay Project – We Develop the Right Solution!
Do you need functional bioassays for drug testing or want to further develop an existing system? Then get in touch with us. Our experienced team will advise you individually, analyze your requirements, and develop customized bioassays – precise, efficient, and to the highest quality standards.
In combination with our Immunoassay Services, specific biomarkers can be detected even more precisely and selectively.
FAQ – Frequently Asked Questions about our Functional Bioassay Services
What types of functional bioassays do you develop?
We develop customized cell-based and microbial bioassays. This includes potency assays, neutralization assays (NAB), proliferation/apoptosis assays, and reporter gene assays to reflect the specific Mode of Action (MoA) of your drug candidate.
How long does it take to establish and validate a bioassay?
The timeline typically ranges from 3 to 6 months for development and qualification. This covers feasibility, method optimization, and final validation for routine use (e.g., for batch release testing).
Can you optimize or transfer existing bioassays (Tech Transfer)?
Yes. We specialize in assay transfer and optimization. We improve existing protocols regarding sensitivity, signal-to-noise ratio, reduced variability (CV), and robustness to ensure reliable results.
Can we provide our own cell lines or proprietary reagents?
Yes. We integrate your proprietary cell lines, antibodies, or proteins. We can also assist with cell banking (MCB/WCB) and characterization to ensure the long-term stability of the assay system.
What is your production capacity for bioassay kits or batches?
We offer flexible scalability. Whether you need small batches for R&D or large-scale production of assay plates for routine QC testing, we adapt the batch size to your specific throughput requirements.
Which quality standards apply to your bioassay services?
Our bioassay development and manufacturing are performed under ISO 13485:2016. As a German contract manufacturer, we ensure full traceability and compliance, suitable for IVD and regulatory submissions.