DO YOU NEED A GMP VALIDATED POTENCY ASSAY?
Does the FDA or your Quality Department tell you that to release your manufactured lots you need a validated potency assay?
Marin Biologic Laboratories is here to help you propel your project forward. For an overview of the process, see designing and validating a GMP cell-based assay.
What does a potency assay entail?
A Contract Manufacturing Organization (CMO) performs various physical-chemical assays on a manufactured lot, such as protein concentration, purity, amino sequence, etc., but usually not its potency.
What is potency? Potency is the biological effect of the drug. To test the potency, the biological effect is measured with varying doses of the drug. The assay is preferably measured in cells (in vitro), not in animals (in vivo). Typical assays are growth or death of cells, production of a protein, change in a cell property, production of a messenger RNA, etc.
The FDA does not specify what readout to use, but they prefer the method to be mimetic of the chosen clinical disease. The objective is to have a method that can detect different biological properties of the drug, such as misfolding, not a simple binding to a target receptor with an appropriate affinity.
What goes into a GMP Validated Bioassay?
The method should be developed to be reproducible, specific to the drug, accurate and precise. The units of potency are usually described by the EC50 determination (effective concentration at 50% maximal) based on fitting the dose-response curve to a 4 Parameter fit (4P, sigmoid curve). A Reference Standard (Ref Std) and a new test sample are assayed in the same experiment, usually in the same 96 well plate. In the example below, a Ref Std and a test sample of a drug that induces the production of the cytokine IL-6 results in curves with well established upper plateau and lower plateau and generally parallel.
Comparison of two samples, a Reference Standard and a Test Sample
The test sample is given a Relative Potency (RP) value relative to the Ref Std, based on the ratio of the two EC50values. The FDA wants to know if a lot manufactured for an animal pre-clinical toxicity study is similar enough to a lot used in a human clinical clinical trial.
Why Choose Marin Biologic Laboratories?
Uncompromising Excellence: Our commitment is to eliminate obstacles in R&D and provide customized solutions that precisely address your unique requirements.
Accelerated Progress: Experience a dramatic reduction in timelines and boost in efficiency with our streamlined procedures and expert assistance.
Gain access to high-quality data: Meticulously validated data for accuracy and relevance, providing unparalleled insight into your research endeavors.
Rapid Regulatory Navigation: Seamlessly navigate regulatory routes and expedite your journey to clinical trials with our industry insights and regulatory expertise.
Unparalleled Communication: Our scientists work as your scientists and provide complete transparency for your understanding of all our data and conclusions.
Our Services:
- We deliver highly specialized cell-based assays to unlock the full potential of your drug discovery process, with over 27 years of expertise in delivering highly specialized cell-based assays. Link: https://www.marinbio.com/services/cell-based-assays/
- Our expertise includes the development and validation of cell-based assays for proliferation, toxicity, expression, and potency testing, ensuring the highest standards of quality and compliance. Link: https://www.marinbio.com/services/cell-based-assays/
