What does potency assay mean?
A potency assay is the quantitative measure of biological activity, ideally it measures the ability of the product to elicit a specific response in a disease-relevant system (Figure 1; [1-4]).
What is a bioactivity assay?
In general, bioassays examine the response of a whole animal, an isolated tissue / cell line or an organism, to a given extract (or drug, chemical or pollutant) in order to evaluate the bioactivity or toxicity or both. Paradoxically the difference between a ‘cure’ and a ‘poison’ is quantity.
Why is potency assay important?
Bioactivity & Potency Assays. Potency testing is necessary to ensure the quality, safety, and efficacy of biopharmaceutical products, as well as the confirmation of biocomparability between an innovator and biosimilar product.
How many types of assay are there?
Assays can be divided into three main categories based on the type of sample used – ligand-binding assays that measure binding between a ligand and a receptor, immunoassays that detect antibody-antigen binding, and bioassays that measure biological activity in response to certain stimuli.
What is the difference between potency and purity?
Purity is a measure of how much of some substance is “what it says on the tin”. Potency in contrast refers to the dose necessary for a substance to exert its effect on the body.
How do you assess potency?
The traditional approach for assessing the potency of biological products is to develop a quantitative biological assay (bioassay) that measures the activity of the product related to its specific ability to effect a given result, and that also meets the criteria listed in Section II.
What are cell-based potency assays?
Cell-based assays determine the relative potency of a product by comparing the biological response/activity, related to its mode of action, with a control/reference preparation (USP, WHO or in-house reference standard).
What is biological potency?
(general) The ability or capacity to perform something. (biology) The ability of a stem cell to differentiate into different cell types. (pharmacology) The measure of the activity of a drug in a biological system.
How is potency measured?
Potency is therefore calculated from the concentration of both molecules, according to the following equation: % Total THC = % THC + (% THCA x 0.877).
What is relative potency?
Relative potency is a term used in bioassay to refer to the ability of a test sample, of unknown potency, to produce the desired response compared to a reference sample, when tested under the same conditions.
What are the different types of bioassays?
There are two types of bioassays: (1) direct assays and (2) indirect assays. In direct assays, the doses of the standard and test preparations are “directly measured” for (or until) an “event of interest”.
What is meant by bioactivity?
Bioactivity is defined as the property of materials to develop a direct, adherent, and strong bonding with the bone tissue.