Testing of raw materials and process auxiliary materials
For quality control of raw materials with different risk levels, the safety risks of exogenous factor contamination from animal (or human) biological raw materials should be fully considered.
Raw materials used in biopharmaceutical production are classified into risk levels based on their source, production process, potential toxicity to biopharmaceuticals, and the risk of exogenous factor contamination. For raw materials of different risk levels, the safety risks of potential exogenous factor contamination should be fully considered during testing.
HyQure BioTech can specifically test the raw materials used in the production process, using tests for sterility, mycoplasma, viral exogenous agents, endotoxins, etc., to demonstrate the quality of cell culture components, additives, and trypsin enzymes in the production process.
