POTENCY ASSAYS FOR BIOPHARMACEUTICAL EVALUATION:
PRECISE TESTS FOR BIOLOGICAL ACTIVITY AND EFFICACY
POTENCY ASSAYS
Potency assays are tests designed to measure the biological activity of a pharmaceutical or biotechnological product, especially in the context of biologics such as vaccines, monoclonal antibodies, gene therapies, and other therapeutic products. These assays allow for the determination of how effective an active substance is in producing a specific effect, which is essential to ensure its efficacy and safety
BENEFITS
Quality Control
They are essential in quality assurance, as they verify the consistency and potency of each production batch. This is particularly important for biological products, whose activity may vary due to their complexity.
Patient Safety
By ensuring that a drug has the appropriate potency, they protect the patient from products that could be ineffective or toxic. Proper doing is based on the product’s potency, minimizing the risk of adverse effects.
Regulatory Compliance
Regulatory agencies such as the FDAor the EMArequire potency assays to approve and monitor pharmaceutical and biological products. They are an integral part of the requirements for batch release and the approval of new drugs.
Optimization of Drug Development
During the development of new products, potency assays help optimize formulation and manufacturing conditions. They facilitate the identification of the minimum effective dose and dose adjustment.
Monitoring Product Stability
Potency assays are useful for evaluating a product’s stability over time. They help determine the shelf life of drugs and ensure that they maintain their potency during storage.
Validation of Manufacturing Processes
They allow for the verification that changes in the manufacturing process do not affect the quality of the final product, ensuring reproducibility and consistency in large-scale production.
TYPES
Cell culture-based biological assays are experimental tests that use live cells grown in the laboratory to assess the biological activity, efficacy, potency, or toxicity of a substance. These assays are essential for understanding how a drug, compound, or biological agent (such as a protein or vaccine) affects cells and tissues.
Biochemical assays are experimental techniques used to measure the activity, concentration, or properties of specific molecules, such as proteins, enzymes, lipids, carbohydrates, or metabolites, within a biological sample. These assays are fundamental for studying biochemical reactions and understanding molecular processes within organisms.
METHOD
DROPLET DIGITAL PCR (DDPCR)
ddPCR is an advanced form of qPCR that enhances precision and sensitivity by partitioning the sample into thousands of tiny droplets. Each droplet is analyzed individually for amplification, enabling highly accurate and absolute quantification of DNA or RNA molecules. This level of precision makes ddPCR an invaluable tool for potency assays, where accurate quantification of nucleic acids is essential to evaluate the biological activity, consistency, and efficacy of gene and cell therapy products.
ELISA (ENZYME-LINKED IMMUNOSORBENT ASSAY)
ELISA is a widely used technique for detecting and quantifying proteins, antibodies, or other biomolecules. By leveraging antigen-antibody interactions, ELISA provides highly sensitive and specific measurements of target molecules. In the context of potency assays, ELISA plays a crucial role in evaluating the biological activity of therapeutic products by quantifying functional proteins, such as enzymes, cytokines, or monoclonal antibodies. This ensures consistency, efficacy, and quality of biology, including gene and cell therapies.
PERSONALIZED SERVICE
At QUATRE, we recognize that every project is unique, which is why we create bespoke solutions to meet your specific needs.
Our personalized service supports the development of your projects by offering assistancein the qualification and validation of your existing protocols. We ensure reliable, tailored results to help drive the success of your work.
Quality Advanced Therapies Research, S.L. holds the Authorizations for Type 2 contained use Facilities (A/ES/23/I-01 and A/ES/23/I-50) to work with genetically modified organisms (Activity Authorizations A/ES/23/01 and A/ES/23/140) granted by the Interministerial Council on Genetically Modified Organisms (CIOMG), affiliated with the Ministry of Agriculture, Fisheries, and Food of Spanish Government.
