Cell-Based Assay (Activity, Infectivity, Binding)
Method Introduction
Cell-based assays are critical analytical techniques used to evaluate biopharmaceutical products’ biological activity, infectivity, and binding properties. These assays involve using living cells to test the functional properties of therapeutic proteins, small molecules, antibodies, and viral vectors. By mimicking the physiological environment, Cell-based assays provide relevant and accurate data on the efficacy and safety of biopharmaceuticals, ensuring their optimal performance in clinical applications.
Applications
Cell-based assays are extensively utilized in various stages of biopharmaceutical development and manufacturing. Key applications include:
- Assessing the biological activity of small molecules, therapeutic proteins and antibodies.
- Evaluating the infectivity and transduction efficiency of viral vectors.
- Testing the binding affinity and specificity of antibodies and receptor-ligand interactions.
- Supporting potency and stability studies by monitoring changes in biological activity over time.
- Conducting comparability studies for biosimilars by ensuring similar biological activity profiles.
Quality and Biosafety Level
We provide all our analytical services with the highest quality standards. Experienced scientists carry out each project, and a scientific reviewer comprehensively checks every report or data presentation.
We offer this technology with the following quality and biosafety levels:
Up to GMP Level
This method is available under GMP in dedicated labs with qualified equipment and full QA involvement.
Up to biosafety level 2
This method can be applied to nucleic acids, viruses, cells, viral vectors and more.
Analytical Method Development, Qualification and Validation
For common sample types, we can often apply standardized methods with little setup effort. However, when needed, our experienced analytical experts create or optimize custom methods tailored to your active pharmaceutical ingredient, product type and development phase.