Importance of Hemolysis Test in Cell Factory

cell factories play an irreplaceable role in cell culture, and the hemolysis test is a vital measure to ensure their quality and safety. Only cell factories that have passed stringent hemolysis testing can provide a stable and reliable environment for cell culture, driving continuous progress in life science research.

In cell culture experiments, a sterile environment, precise control of gas and pH levels, and suitable osmotic pressure are all essential conditions for the healthy growth of cells. In large-scale cell culture applications such as vaccine preparation and monoclonal antibody production, the cell factory plays a critical role due to its efficiency and stability. However, the quality of the cell factory directly impacts the growth state of the cells, making strict quality control particularly crucial.

The hemolysis test, as an important component of quality inspection for cell factories, aims to evaluate the potential impact of their materials on blood cells. When cells come into contact with the surface of the device or are exposed to material extracts, hemolysis may occur—a phenomenon where the cell membrane ruptures, leading to the leakage of intracellular contents. This not only damages cell health but may also disrupt the entire cell culture process.

In accordance with international and national standards such as ISO 10993-4:2017 and GB/T 16886.4-2003, we conduct hemolysis tests for cell factories. By exposing the test sample, negative control, and positive control to fresh rabbit anticoagulated blood and measuring absorbance using a UV-visible spectrophotometer, we calculate the hemolysis rate of the test sample. Only when the hemolysis rate does not exceed 5% can the safety of the cell factory material be ensured.

Cell Factory 10 Layers TC-treated

The hemolysis test is not only a rigorous inspection of the material quality of cell factories but also a strong safeguard for the safety of cell culture. Through this test, we can promptly identify and eliminate leachable compounds that may cause in vitro hemolysis of red blood cells, thereby preventing cell hemolysis caused by unqualified culture containers.

In summary, cell factories play an irreplaceable role in cell culture, and the hemolysis test is a vital measure to ensure their quality and safety. Only cell factories that have passed stringent hemolysis testing can provide a stable and reliable environment for cell culture, driving continuous progress in life science research.