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【bio-news】FDA发布了关于细胞病毒疫苗的指导规范
Pharmaceutical News
Published: Thursday, 28-Sep-2006
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The U.S. Food and Drug Administration (FDA) has issued new guidance to aid manufacturers in developing safe and effective cell-based viral vaccines.
FDA's goal is to facilitate the development and availability of safe and effective vaccines, including those to address emerging and pandemic threats.
"The guidance document released today is a vital part of our overall efforts to help manufacturers develop new vaccines that are critical to meeting global public health needs," said Acting Commissioner Andrew von Eschenbach, M.D., Food and Drugs. "This guidance promises to help modernize the development of life-saving vaccines for influenza and other diseases and facilitate the development of more plentiful, reliable supplies."
In the guidance, FDA provides manufacturers of viral vaccines with updated recommendations to the 1993 document "Points to Consider in the Characterization of Cell Lines Used to Produce Biologics." The updated guidance conveys information for determining the suitability of a cell culture for manufacturing, as well as testing and validating the safety and purity of the cells used in the development and production of viral vaccines. It also provides information on testing at different stages of production and quality-control test methods for cell substrate and adventitious agent issues.
Cell cultures are used to produce licensed vaccines that help protect against diseases such as measles, mumps and polio. Today's guidance outlines the best practices using current and emerging science.
Cell-based vaccine manufacturing holds the promise of a reliable and flexible alternate method of producing influenza vaccines, which are currently produced in chicken eggs by a technique developed more than 50 years ago.
With increasing demand for seasonal influenza vaccine and with the potential threat of a pandemic, as well as other emerging infectious diseases (for example, SARS), more flexible approaches that allow surge capacity in an emergency are critical. With cell-based manufacturing, cells can be frozen and stored and thawed as needed to produce more vaccine.
"This guidance document provides important advice for manufacturers on using cell cultures to produce needed vaccines against infectious diseases and to use modern technologies to assure that they meet the highest safety expectations," said Jesse Goodman, M.D., M.P.H., director, Center for Biologics Evaluation and Research, FDA. "The advice will assist manufacturers, including those that make influenza vaccine, both to develop new and better vaccines and to boost production capacity, making us better prepared for the threat of a future influenza pandemic and other infectious diseases."
A copy of the guidance, "Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases," is available at: www.fda.gov/cber/gdlns/vaccsubstrates.pdf. The public has 90 days to comment on the draft document. When finalized, the guidance will represent FDA's current thinking on this topic.
http://www.fda.gov 认领了 放弃了，没时间。不好意思：（ 试译!不是本专业,请大家批评指正!! FDA issues guidance for development of cell-based viral vaccines
Pharmaceutical News
Published: Thursday, 28-Sep-2006
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FDA发布了关于细胞病毒疫苗的指导规范
制药新闻
发布时间：星期二，2006年9月28日
The U.S. Food and Drug Administration (FDA) has issued new guidance to aid manufacturers in developing safe and effective cell-based viral vaccines.
FDA's goal is to facilitate the development and availability of safe and effective vaccines, including those to address emerging and pandemic threats.
为了开发安全有效的细胞病毒疫苗，美国食品与药品监督管理局(FDA)已经向制造商颁布了新的指导规范。
FDA的目的是为了加强安全有效的细胞病毒疫苗的开发和应用性，其中包括那些针对于那些目前广泛流行的重大疾病的疫苗。
"The guidance document released today is a vital part of our overall efforts to help manufacturers develop new vaccines that are critical to meeting global public health needs," said Acting Commissioner Andrew von Eschenbach, M.D., Food and Drugs. "This guidance promises to help modernize the development of life-saving vaccines for influenza and other diseases and facilitate the development of more plentiful, reliable supplies."
FDA代理委员Andrew von Eschenbach说,‘今天发布的指导规范文件是我们全部工作的至关重要的一部分，旨在帮助制造商开发满足世界公共健康的新型疫苗。’‘这份指导规范将会推动开发拯救生命的疫苗（如治疗流感等疾病的疫苗）的现代化，促进这些疫苗能够保证数量和质量的供应。’
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作者:admin@医学,生命科学 2011-08-13 05:11
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