Bacterial endotoxin should also be tested during the preparation of biological agents. There are many kinds of biological agents, including vaccines, vaccines, blood products, and interferon (IFN). How do they detect bacterial endotoxin?

1、 Vaccine

During the preparation of the vaccine, it will be more or less contaminated by endotoxin, especially the gram-negative vaccine, which will be more contaminated by endotoxin. In order to better detect bacterial endotoxin in the vaccine, the Limulus test method with high sensitivity, fast detection speed, accuracy, and quantification can be used. It was found that when the bacterial endotoxin content of the polysaccharide vaccine was detected by limulus test, the highest level of endotoxin content was found in the vaccine (14000ng endotoxin/100 μ g) Its fever reaction rate is also the highest, and the anal temperature of 1.8~1.9% is more than 38.5 ℃; But the vaccine with low bacterial endotoxin content (600ng/100 μ g) The reaction is also low.

According to this test, it can be seen that the Limulus test method used to detect bacterial endotoxin can effectively improve the production technology of the vaccine, and its reaction rate will also be reduced so that the vaccine can achieve a satisfactory purification effect. Therefore, the Limulus test method is an infallible method for bacterial endotoxin detection of the vaccine.

2、 Vaccines

At present, the Limulus test method is highly popular and efficient, and reliable in the test. The Limulus test method has also been successfully used in the quality control of influenza vaccines to detect the bacterial endotoxin content in the influenza vaccine. A researcher carried out a bacterial endotoxin test on 26 batches of influenza vaccines produced by 6 manufacturers in the United States and found that the bacterial endotoxin content of this influenza vaccine was very different between batches. Therefore, the FDA of the United States specially prepared a batch of standard influenza vaccines for safety testing and use, requiring that the bacterial endotoxin content of all newly produced A/swine influenza vaccines used for human immunization should not exceed 6ng/ml. This regulation has greatly improved the quality of the A/swine influenza vaccine.

3、 Blood preparation

The Limulus test method is also used in the quality control of blood products. Because of the presence of endotoxin inhibitor protein in plasma or serum, the blood preparation must be pretreated before the bacterial endotoxin test by the Limulus test. The detection of bacterial endotoxin content in blood preparations by the Limulus test can effectively eliminate the possibility of bacterial endotoxin contamination and effectively ensure the safety of blood preparations.

1、 Interferon (IFN)

Lymphocytes stimulated by inducers in vitro will produce a glycoprotein, which is our common interferon (IFN). More and more studies have found that interferon (IFN) can cause fever, stimulate B lymphocytes, inhibit T lymphocytes and other symptoms, and has many of the same reactions as bacterial toxins. However, some people believe that the same symptoms as bacterial endotoxin can occur because interferon (IFN) is contaminated by bacterial endotoxin during the preparation process. So using the Limulus test to detect the bacterial endotoxin content of interferon (IFN) can effectively reduce the side effects of interferon (IFN).

In a word, the use of limulus lysate method to detect the bacterial endotoxin content of biological agents can better ensure the use safety of biological agents.