Potency assays are essential for evaluating the effectiveness of biological products, measuring both their impact and consistency. In these assays, at least one test must quantify the product’s biological activity, enabling accurate conclusions about its efficacy.
Below are some of the most widely used techniques to quantify different biological activities:
- High-Performance Liquid Chromatography (HPLC)
HPLC is crucial for analyzing complex mixtures. This technique separates the compounds in a sample, allowing for the identification and quantification of each one. It’s especially useful when a product transforms or promotes the accumulation of a specific substance, providing a detailed measurement of changes in the sample.
- Quantitative and Digital PCR
For products that induce specific gene expression, quantitative (qPCR) and digital PCR (dPCR) are ideal. These methods quantify gene expression using primers and specific probes, providing precise data on how the product influences genetic activity.
- ELISA Assays
When a product acts as a ligand and triggers the production of a specific molecule, ELISA assays measure its concentration via a plate reader. To study the direct interaction between a ligand and its receptor, the ligand can be labeled with radioisotopes, and its binding quantified using a scintillation counter, which measures emitted radiation.
- Flow Cytometry
For products that impact cellular processes like proliferation or apoptosis, flow cytometry is highly effective. This method uses fluorescent probes that target key molecules in these cellular processes, allowing for a detailed analysis of how the product affects each cell in the sample.
Conclusion
These techniques enable detailed data on biological activity in potency assays, from molecular composition to cellular response. Choosing the right technique ensures the precision and effectiveness of these assays, supporting the development of reliable and effective biotechnology and pharmaceutical products.
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