Investigation of xenotropic murine leukemia virus-related virus (XMRV) in human and other cell lines [0.03%]
人及其他细胞系中偶异型鼠白血病病毒相关病毒(XMRV)的调查研究
Dhanya K Williams,Teresa A Galvin,Hailun Ma et al.
Dhanya K Williams et al.
Xenotropic murine leukemia virus-related virus (XMRV) was discovered in human prostate tumors and later in some chronic fatigue syndrome (CFS) patients. However, subsequent studies have identified various sources of potential contamination ...
Glycan analysis of glycoprotein pharmaceuticals: Evaluation of analytical approaches to Z number determination in pharmaceutical erythropoietin products [0.03%]
甘蛋白药物糖链分析：对药品促红细胞生成素产品中Z值测定分析方法的评估
Chun-Ting Yuen,Yong Zhou,Qing-Zhou Wang et al.
Chun-Ting Yuen et al.
N-Glycosylation of many glycoprotein drugs is important for biological activity and should therefore be the target of specific and quantitative analytical methods. In this study, we focus on the two N-glycan mapping approaches that are used...
Risk perception, risk management and safety assessment: what can governments do to increase public confidence in their vaccine system? [0.03%]
风险感知、风险管理及安全性评价：政府应如何提高民众对疫苗接种系统的信心？
Noni E MacDonald,Jennifer Smith,Mary Appleton
Noni E MacDonald
For decades vaccine program managers and governments have devoted many resources to addressing public vaccine concerns, vaccine risk perception, risk management and safety assessment. Despite ever growing evidence that vaccines are safe and...
Comparative efficacy of live replicating sheeppox vaccine strains in Ovines [0.03%]
绵羊痘活疫苗株在绵羊体内的比较效力研究
R Yogisharadhya,V Bhanuprakash,M Hosamani et al.
R Yogisharadhya et al.
In the present study, two sheeppox vaccines made from strains [sheeppox virus-Srinagar (SPPV-Srin) and Ranipet (SPPV-R)] indigenous to India and adapted to Vero cells were compared in terms of their safety, potency, efficacy and antigenic v...
Effectiveness of mouse minute virus inactivation by high temperature short time treatment technology: a statistical assessment [0.03%]
高温短时间灭活法制备鼠细小病毒的失活效果统计分析
Marie Murphy,Guillermo Miro Quesada,Dayue Chen
Marie Murphy
Viral contamination of mammalian cell cultures in GMP manufacturing facility represents a serious safety threat to biopharmaceutical industry. Such adverse events usually require facility shutdown for cleaning/decontamination, and thus resu...
Collaborative study for the calibration of a replacement International Standard for Tetanus Toxoid Adsorbed [0.03%]
破伤风类毒素吸附国际标准替代品校准的协作研究
Rob Tierney,Paul Stickings,Jason Hockley et al.
Rob Tierney et al.
We present the results of a collaborative study for the establishment of a replacement International Standard (IS) for Tetanus Toxoid Adsorbed. Two candidate preparations were included in the study, one of which was established as the 4th I...
Epidemiological designs for vaccine safety assessment: methods and pitfalls [0.03%]
疫苗安全性评价的流行病学设计：方法与陷阱
Nick Andrews
Nick Andrews
Three commonly used designs for vaccine safety assessment post licensure are cohort, case-control and self-controlled case series. These methods are often used with routine health databases and immunisation registries. This paper considers ...
Vaccination of sex reversed hybrid tilapia (Oreochromis niloticus × O. aureus) with an inactivated Vibrio vulnificus vaccine [0.03%]
用灭活的威氏气单胞菌疫苗免疫性别转换的尼罗罗非鱼（Oreochromis niloticus×奥利亚罗非鱼）杂交种
Craig A Shoemaker,Benjamin R Lafrentz,Phillip H Klesius
Craig A Shoemaker
Vibrio vulnificus causes disease in economically important aquaculture raised fish and is an opportunistic human pathogen. This study reports on the isolation of V. vulnificus from diseased hybrid tilapia (Oreochromis niloticus × O. aureus...
Validation of model virus removal and inactivation capacity of an erythropoietin purification process [0.03%]
验证促红细胞生成素纯化工艺模型病毒去除和灭活能力
Mayté Pérez,Elias Rodríguez,María Rodríguez et al.
Mayté Pérez et al.
Human erythropoietin (hEpo) production requires mammalian cells able to make complex post-translational modifications to guaranty its biological activity. As mammalian cell can be reservoir of pathogenic viruses and several animal origin co...
Post-licensure evaluation of vaccine safety: current status and future directions. Symposium organised by the International Alliance for Biological Standardization (IABS) in Barcelona, Spain, 27-28 April 2011 [0.03%]
疫苗上市后安全性评价现状及未来展望国际生物标准联盟(IABS)于2011年4月27-28日在西班牙巴塞罗那组织召开研讨会
Steven Black,William Egan,Paul-Henri Lambert
Steven Black
Adverse events following immunization, while rare, unfortunately do occur. And when they do, the public's faith in vaccines waves. It's a known fact, for example, that vaccine safety concerns are among the most important factors contributin...