Systematic evaluation of in vitro and in vivo adventitious virus assays for the detection of viral contamination of cell banks and biological products

Author:

Gombold James,Karakasidis Stephen,Niksa Paula,Podczasy John,Neumann Kitti,Richardson James,Sane Nandini,Johnson-Leva Renita,Randolph Valerie,Sadoff Jerald,Minor Phillip,Schmidt Alexander,Duncan Paul,Sheets Rebecca L.

Funder

National Institute of Allergy and Infectious Diseases

National Institutes of Health, Department of Health and Human Services

Publisher

Elsevier BV

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health,General Veterinary,General Immunology and Microbiology,Molecular Medicine

Reference17 articles.

1. Additional standards: poliovirus vaccine, live, oral;Porterfield;Federal Register Doc. Nov. 23,1960

2. Vaccine cell substrates 2004;Sheets;Expert Rev Vaccines,2004

3. US Food and Drug Administration Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications; 2010. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/default.htm, accessed 12/5/2012.

4. European Pharmacopoeia Version 7. Tests for extraneous agent in viral vaccines for human use. European Directorate for the Quality of Medicines and HealthCare of the Council of Europe; 2010.

5. International Conference on Harmonisation—Quality 5D, US Food and Drug Administration; 2012. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm, accessed 12/5/2012.

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3