Virus in deactivated bioproduct and method of removing toxin in bacteria

Abstract

The invention relates to an inactivation biological product virus and removing bacterial endotoxin method. The biological product or middle product is adjusted its pH value to 12.0+ / -0.2 by NaOH solution, hatched for at least one hour at 25+ / -1 centigrade degree, then adjusted its pH value to need by HCl solution. The method has good inactivation effect for all fat enveloped virus or non. It has done a lot of test for many viruses. And all of them have good inactivation effect. It is qualified tested by TAL and rabbit detection pyrogen.

Description

technical field [0001] The invention relates to a method for inactivating viruses in biological products and simultaneously removing bacterial endotoxins. It belongs to the field of virus inactivation of biological products. Background technique [0002] Products such as medicines, food, and health care products made from extracts of living organisms, biological organs, and blood are called biological products. Organisms, biological organs, especially blood contain various types of infectious viruses and bacterial endotoxins. Viruses mainly include DNA and RNA. From the perspective of virus structure, there are lipid-enveloped viruses and non-lipid-enveloped viruses. Specific viruses include: HBV, HCV, HIV-1, HIV-2, HTLV, and parvovirus B19, etc., are numerous. In order to ensure the safety of the use of biological products, it is necessary to remove / inactivate viruses and remove bacterial endotoxins on intermediate or finished products during the production process of bio...

AI Technical Summary

Problems solved by technology

[0004] 1. Pasteurization method (pasteurization method) and dry heat method (heating at 80°C for 72 hours), the inactivation effect is relatively certain, but sometimes it cannot be used due to the greater impact on the biological activity of some cytokines

[0005] 2. The organic solvent / detergent (S / D) treatment method has strict requirements for the whole process of inactivating viruses, and is ineffective for non-enveloped viruses

[0006] 3. The nano-membrane filtration method can only be used if the membrane pore size is smaller than the effective diameter of the virus, which has great limitations. The effect of inactivating the virus is easily affected by many factors and must be used in combination with other methods

[0007] 4. Low pH incubation method, this method can inactivate several lipid-enveloped viruses, but the inactivation effect is difficult to control

[0008] None of the above virus inactivation methods can be applied to both lipid-enveloped viruses and non-lipid-enveloped viruses, and the effect is not complete. Therefore, it is difficult to inactivate all viruses at once. Generally, several methods need to be used in combination

The implementation effect of the above method is affected by many factors, the stability is poor, and the pyrogen cannot be removed at the same time, and the removal of endotoxin cannot be taken into account.

Bacterial endotoxins need to be removed by ultrafiltration or chromatography. The former is mainly suitable for small molecular weight infusion drugs, such as water for injection, etc.; the latter has a wide range of applications, but the equipment is expensive and costly. limited quantity