Kit for removing bacterial endotoxin in biological product, method thereof, and preparation method of biological product

Abstract

The invention discloses a kit for removing bacterial endotoxin in a biological product, a method for removing the bacterial endotoxin in the biological product by using the kit, and a preparation method of the endotoxin removed biological product. The kit includes an anionic surfactant and a potassium salt. The methods commonly comprise the following steps: fully combining the anionic surfactant with the endotoxin in the biological product to form a conjugate, adding the potassium salt to precipitate the conjugate, filtering to remove the obtained precipitate in order to obtain an endotoxin removed biological product solution, and separating the biological product from the biological product solution. The kit can be used to simply and efficiently remove the endotoxin in the biological product and has a low cost, and the endotoxin removal method has the advantages of easy operation, no influences on the bioactivity of the biological product, and only use of compounds allowed in the medicine industry. The content of the endotoxin in the biological product prepared by using the methods accords with clinic pharmacy standards, and the loss of active substances is less.

Description

technical field [0001] The invention relates to the field of separation and purification of biological products, in particular to a kit for removing bacterial endotoxin from biological products, a removal method and a preparation method of biological products for removing endotoxin. Background technique [0002] With the wide application of modern biotechnology, more and more attention has been paid to the safety of biological products, especially the stricter control of pyrogens in biological products. However, in the production process of biological products, pyrogens are often introduced due to factors such as raw materials and auxiliary materials, production environment, and personal operation. Release active substances and introduce a large number of pyrogens, contaminating biological products. Therefore, in addition to taking effective process control and strict preventive measures in the production process to reduce the source of pyrogens, how to remove pyrogens in b...

AI Technical Summary

Problems solved by technology

Common removal methods include ultrafiltration, various column chromatography (such as hydrophobic chromatography, ion exchange), affinity adsorption (polymyxin B, L-histidine, poly-L-lysine, poly-L-lysine, Poly-γ-L-glutamic acid cross-linking medium) and cloud point extraction (Triton X-114), etc., these methods can remove or inactivate part of endotoxin, but there are certain shortcomings

For example, ultrafiltration can only be applied to small-molecule drugs. If the drug molecules (such as antibodies) and endotoxin molecules are close in size, they cannot be effectively separated; column chromatography is costly and inefficient, and is not suitable for large-scale production of bacterial endotoxins. removal of the same negatively charged biomolecules by anion exchange resins; cloud point extraction (Triton X-114) [4] There are also great disadvantages such as the need for multiple extractions during the operation, resulting in the loss of active substances in the plasmid; the temperature needs to be switched during processing, and after the phase transition, Triton X-114 forms very fine droplets and exists in the water phase, which requires high-speed centrifugation , difficult to industrial operation and control, etc.

Images