As one of the critical points of quality control in the biopharmaceutical process, filtration technology has been widely used in the biopharmaceutical field. Filtration products are also widely used in the production of antibiotics and amino acids, the clarification of fermentation broth and culture solution, the sterilization of biological products, the removal of pyrogens and the enrichment of polypeptides, proteins, enzymes, cells, viruses and other macromolecules. Jiuwu Hi-Tech membrane filtration equipment is also widely used in product concentration and purification, Chinese medicine extract preparation and Chinese medicine extraction process. In addition, filtration technology is also widely used in process water, bottle washing water, oral liquid, water for injection, pure water, ultrapure water and Chinese medicine injections in the pharmaceutical production process.
The rapid development of life sciences and biotechnology provides new opportunities for the development of vaccines: the rapid mass production of vaccines, the continuous improvement of quality standards, and the development and application of new technologies have become the technological development trend of the industry. The emerging hollow fiber membrane filtration technology has the advantages of mild and low shear force, high dust holding capacity, flexible operation, long life, low cost, and easy amplification, which solves the big technical problems of easy clogging of the membrane when virus particles are concentrated and sensitivity to shear force with easy aggregation, so it is widely used in the fields of biopharmaceutical and life science research such as vaccines. The new hollow fiber membrane filtration technology is beneficial to improve the quality of vaccine products and increase production efficiency. The combination of hollow fiber membrane filtration technology, micro-carrier cell ball transfer amplification culture technology and high-selectivity chromatography new filler technology can better adapt to the challenges of large-scale vaccine production.
Vaccine is one of the most important biological products. Vaccines against viral diseases include inactivated virus vaccines, live attenuated vaccines, subunit vaccines and nucleic acid vaccines. In the unpurified antigen stock solution, there are a large number of substances in the nutrient solution, and impurities such as nucleic acid, protein and lipid of the host. These impurities are usually used as a heat source, causing adverse reactions after injection of animals. In order to improve the purity of the vaccine, it is necessary to purify the vaccine to meet the safety and effectiveness requirements of the vaccine. In the process of vaccine purification, ultracentrifugation, ultrafiltration, and chromatography are often used to achieve sufficient purity and antigen concentration.
Hollow fiber has excellent chemical stability, long life span, and low cost per membrane area. It is also widely used in the concentration of veterinary virus vaccines such as foot-and-mouth disease and rabies, which can improve product quality. The hollow fiber membrane can fully trap the rabies virus, achieve high antigen yield, and effectively remove bovine serum albumin, improving the safety, effectiveness and stability of the vaccine.
At present, most domestic veterinary vaccine manufacturers still use more traditional production processes, such as spinner cultivation, silk cloth filtration, dialysis, and there is an urgent need to introduce new modern biotechnology to improve existing production processes. The production process combined with hollow fiber membrane separation technology and the chromatographic technology, through the optimization and control of the process parameters, is not only beneficial to protect the activity of the virus macromolecules, but also can better remove various impurities, greatly improve the product quality and significantly improve the production efficiency.
Increasingly prominent vaccine safety issues require vaccine manufacturers to strictly control the production process and process parameters. The upstream and downstream processes need to be considered comprehensively, and on the basis of maintaining the stability of the upstream culture process, the removal rate of impurities in each step of the operation should be improved as much as possible to ensure the quality of the final product.