Biopharmaceutical refers to substances used to prevent, treat, and diagnose human diseases, purposefully regulate human physiological functions, and provide indications or functional indications, usage, and dosage. Including traditional Chinese medicine, chemical raw materials and their preparations, antibiotics, biochemical drugs, radioactive drugs, serums, vaccines, blood products and diagnostic drugs. Sterile drugs refer to the preparations and drug substances that are listed in the statutory drug standards for sterility inspection items, including sterile drugs and sterile drug substances. Such drugs probably include the following categories: all injections, all implants, all plasters, sprays, gels and other preparations for wounds. Most bacteria are harmful to the human body because of endotoxins, so medicines that may come into contact with blood and body fluids need to strictly control endotoxins.
The testing and removal of the drug's endotoxin may be performed directly on the final drug, or it may be performed on the drug substance and the preparation process. Either way, it has strictly controlled the content of endotoxin.
Limulus amebocyte lysate testing kits have also been widely used, such as endpoint color development, limulus amebocyte lysate deformed cell lysate (LAL) measurement, dynamic turbidity LAL measurement, and kinetic color development LAL measurement. The Endosafe PTS test method is a rapid quantitative kinetic color development system that can obtain test results within 15 minutes. Many foreign reports have reported that it can be used to detect bacterial endotoxins in radioactive injected varieties, such as 123I-m-iodobenzidine and 18F, 11C and 13N labeled radiopharmaceuticals. Some studies have reported that this method is used to detect endotoxin in 18F-FDG injection. Comparative tests show that this method is fast and accurate. At present, the PTS detector provides a fast, simple and reliable method for detecting the content of bacterial endotoxin in radiopharmaceutical injections. The application of radioactive injection can detect bacterial endotoxins in time before administration to ensure the safety of drugs.
| Project name | Endotoxin testing in biopharmaceutical |
| Testing purpose | Biopharmaceutical will directly contact human tissues and organs, therefore， endotoxins must be tested before use. |
| Testing cycle | 3-5 days. |
| Service including | We provide you with raw data and test reports. |
| Price | Inquiry |
Creative BioMart offers a corresponding endotoxin testing service. You can purchase the corresponding endotoxin removal kit and related accessory products according to the needs of your own samples. We guarantee that all instruments, water, reagents, and consumables used in the experiment are free of endotoxins, and the experiment is conducted in a clean room to ensure that low levels of endotoxins are returned to the sample. In addition, we can also provide you with related services including:
