On September 3, the A-type H1N1 flu vaccine produced by Beijing Kexing Biological Products Co., Ltd. was awarded the drug approval number issued by the State Food and Drug Administration. This is also the world's first A-type H1N1 flu vaccine that has obtained the production batch number. The entire vaccine development cycle took only 87 days from the company's June 8 virus strain obtained directly from the World Health Organization for vaccine production.
Development, trial production, clinical trials, on-site inspection, registration inspection, review and approval... In order to complete the development of influenza A H1N1 vaccine in a short time, China's vaccine production enterprises, drug testing and supervision institutions, health and disease control departments and other joint operations In order to achieve the goal of letting the people vaccinate one day earlier, go all out.
“Is the vaccine developed one day earlier, so that the people can be protected one day earlierâ€
In April 2009, the H1N1 flu virus spread from North America to the world, and a sudden flu campaign was launched. As one of the effective means to prevent and control influenza spread, the development and production of influenza A H1N1 vaccine is expected. Whether the vaccine can be developed one day earlier means that the people can be protected one day earlier.
Obtaining the strains provided by the World Health Organization is the basis for the development of vaccines for enterprises. At 20:00 on June 3, with the cooperation of the customs and quality inspection departments, the production of the H1N1 influenza vaccine produced by the laboratory approved by WHO was delivered to the Hualan Biological Engineering Co., Ltd., which is headquartered in Henan. the company. As the first vaccine manufacturer in China to obtain strains, Hualan Bio started the development of the influenza A H1N1 vaccine at * time.
"Either scientific research, management personnel, or front-line workers, from this moment on, every minute is inevitable." Looking back over the past three months, Fan Lan, executive vice president of Hualan Bioengineering Co., Ltd. said with emotion, for the H1N1 With the development of the flu vaccine, almost all the staff members have taken the business as their own, and they work day and night, and it is not uncommon to eat.
On September 1st, the H1N1 influenza split vaccine developed by Hualan Biological passed the expert review of the National Drug Evaluation Center and is expected to obtain the drug approval number issued by the State Food and Drug Administration before September 4. This is only a three-month period from the company to get the standard strain, almost in sync with Beijing Kexing.
“The large population is a major challenge for China compared to other countries. The vaccine can be put into use one day earlier. Protecting key populations and susceptible people as early as possible can minimize the losses caused by influenza pandemics.†Beijing Kexing Biological Products Yin Weidong, director of the company, said.
At the same time as companies step up research and development, government departments are also active. From June to August, the State Food and Drug Administration issued a series of documents such as the Notice on Preparing for the Production of Influenza A H1N1 Influenza and the Emergency Work Plan for Special Approval of Pandemic Influenza Vaccines for approval of vaccine review. The work laid the foundation for the policy.
Under the principle of “no reduction in procedures and no reduction in standardsâ€, the State Food and Drug Administration requires “three synchronizations†in the review and approval process for influenza A H1N1 influenza vaccine, that is, the drug review center will divide the technical review and the enterprise. The segment declaration is synchronized, and the drug certification management center synchronizes the production site inspection with the production process of the enterprise. The China National Institute for the Control of Pharmaceutical and Biological Products synchronizes the clinical samples and batch issuance inspection with the self-inspection of the enterprise.
"It is the deployment of science that realizes the zui optimization of work flow and the work efficiency, and strives for the development and production of the influenza A H1N1 flu vaccine." Zhang Wei, director of the Drug Registration Department of the State Food and Drug Administration said .
"No matter how much pressure on the head, we only believe in one principle, that is science."
Influenza A (H1N1) is a brand new virus. In the early days of the epidemic, the world did not have enough knowledge of the virus.
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