Potency testing is a term used to describe the process of measuring biological activity in a product. Many methods exist to determine the potency of a biopharmaceutical such as ligand and receptor binding assays, cell culture based assays, and animal based assays.
Determining potency is a very important step in the biopharmaceutical development cycle, requiring a significant amount of time and effort. In early development, binding assays are most often preferred, whereas toward the end of development cell based assays are preferred.
Once an assay to determine the potency has been developed it must be validated to prove it is suitable for its intended use. This usually requires demonstration proving accuracy and precision. Degredation studies are often commonly done to confirm stability.
Requests for Potency Testing of Biopharmaceuticals Received by Contract Laboratory
- Europe pharma needs bioanalytical laboratory for potency assay testing of human growth hormone
- Pharmaceutical preclinical laboratory needed for in vitro potency testing of COX 1-2 inhibitors
- IEC 17025:2005, FDA cGMP laboratory needed for analytical chemistry and microbiology testing of Coleus forskohlii / Plectranthus barbatus food supplements -Potency/extract level -Microbiological contaminants -Heavy metals -etcetera
- FDA Pharmaceutical Laboratory needed for USP Testing: antibiotic potency test as per USP <81> verification and release for one type of antibiotic using the cylinder method
- Microbiology Laboratory needed for sterility, endotoxin and potency testing for sodium tetradecyl sulfate, polidocanol, and glycerin
- Pharmaceutical Microbiology Laboratory needed for USP sterility testing services including but not limited to: sterility and endotoxin validation, potency over time, endpoint sterility testing, and release testing (sterility, endotoxin, and potency) to USP standards For a current research study, we are compounding synthetic peptide manufactured using synthetic amino acid derivatives, as well as solvents and reagents of non-human and non-animal sources.
- ISO 17025:2005, FDA registered , cGMP USA pharmaceutical analytical chemistry laboratory needed for potency testing for Hyaluronidase Human Chorionic Gonadotropin (hCG) (monograph available online) Phosphatidylcholine/Deoxycholic acid (PPC/DC)
- and more can be seen on our website!
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