Endotoxin Retest Verification Testing for Biologics
The integrity and safety of biologics are paramount in pharmaceutical testing. Endotoxin retest verification is a critical step to ensure that the products meet stringent regulatory requirements and quality standards. This service ensures that any biopharmaceutical or biosimilar undergoes rigorous testing to confirm its endotoxin levels comply with international standards.
Endotoxins are pyrogenic substances derived from gram-negative bacteria, which can be harmful if present in high concentrations in biologics like vaccines, monoclonal antibodies, and therapeutic proteins. Regulatory bodies such as the FDA, the EMA, and the ISO have set strict limits on endotoxin levels in these products. Compliance with these limits is essential for patient safety, regulatory compliance, and maintaining product quality.
The process of retesting and verification involves several key steps. The specimen must be thoroughly prepared according to established protocols, typically involving dilution or concentration based on the expected endotoxin level. This preparation ensures accurate results from the testing process. Once prepared, the sample is subjected to a LAL (Limulus Amoebocyte Lysate) test using a kinetic浊化<|im_start|><|im_start|>⚗️
