Freeze-dried human rabies vaccine was officially put into production in Chengdu
It was learned from the Sichuan Provincial Food and Drug Administration that the freeze-dried human rabies vaccine (human diploid cells) developed by Chengdu Biological Products Co., Ltd. had obtained the State Food and Drug Administration's drug registration approval and new drug certificate, and was officially put into production in Chengdu. This species is the first biological product new drug approved by the State Bureau in 2012, and it is also the first human rabies vaccine approved for production in China.
It is reported that the human diploid cell rabies vaccine is a universally recognized vaccine with the best immunity and safety. It uses a cell matrix that is homologous to humans, has no allergies, and has a long duration of antibodies. It has been used in Europe, America, Hong Kong, and Taiwan. There are sales in major developed countries and regions, but they have not yet been imported into China for sale. Before the variety was approved for marketing, the production of cell substrates for human rabies vaccine (including imported vaccines) in mainland China was mainly chicken embryos, hamsters, and African green monkey (VERO) cells.
After the human diploid cell rabies vaccine is put into production in Chengdu, it will make a positive contribution to reducing the morbidity and mortality of rabies in China.
As early as 2004, Chengdu Biological Products Co., Ltd. began to develop human diploid cell rabies vaccine. In 2011, it passed the on-site inspection of the State Food and Drug Administration. In May 2012, it obtained the SFDA production approval and new drug certificate (new drug certificate number: SFDA certificate S20120001).
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At present, China's vacuum freeze-drying equipment tends to be perfect, but compared with developed countries, the study of this technology's basic theory appears to be lagging behind and weak, impeding the improvement of the level of technical application. Therefore, the focus of the study is shifting to this aspect. At present, the focus of the research is on the study of vacuum freeze-drying parameters and its influencing factors, process parameters, process mechanism and model, and process optimization control.
The basic parameters of vacuum freeze-drying technology include physical parameters and process parameters, which are the basis for achieving the vacuum freeze-drying process. The lack of these data will make it difficult to optimize the raw materials for the drying process, and it will not be able to make full use of the system efficiency. Physical properties refer to the thermal conductivity, transfer coefficient, etc. of the material. The research contents in this area include the determination and measurement methods of physical parameter data, and the influence of environmental conditions such as pressure, temperature, relative humidity and material particle orientation on the physical properties. Process parameters include parameters such as refrigeration, heating, and material morphology. The study of the freezing process is intended to find the optimal freezing curve for the system. The research of heating process focuses on two aspects: one is the improvement of the raw material carrier; the other is the choice of heating method (heat transfer method and heat source). Determining the proper material form is also an important research content, which includes the particle form of the raw material and the thickness of the material layer.
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