Erythropoietin (EPO) is a glycoprotein hormone produced by the kidneys to regulate red blood cell production. Recombinant EPO is used in treating anemia due to chronic kidney disease or chemotherapy. The USP standard supports bioidentity and potency testing using validated cell-based assays.
The USP biologics proteins category provides critical standards and reference materials necessary for the development and manufacturing of therapeutic proteins. These proteins, which can be naturally derived or genetically engineered, are essential in treating various diseases and conditions, ensuring that they meet quality, safety, and efficacy standards.
The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.
| MDL number | MFCD00015392 |
|---|---|
| NACRES | NA.24 |
| UNSPSC Code | 41116107 |
| grade | pharmaceutical primary standard |
| agency | USP |
| API family | erythropoietin |
| form | solid |
| manufacturer/tradename | USP |
| application(s) | USP Biologicspharmaceutical |
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