Inactivation and removal of influenza A virus H1N1 during the manufacture of plasma derivatives [0.03%]
甲型H1N1流感病毒灭活及去除在血浆衍生物制品生产过程中的消除与清除研究
Eun Kyo Jeong,Hark Mo Sung,In Seop Kim
Eun Kyo Jeong
Although transmission of pandemic influenza A virus H1N1 2009 is still occurring globally, little has been reported about how this outbreak has affected the safety of plasma derivatives. To evaluate the safety of plasma derivatives, dedicat...
Evaluation of fourth international standard for whole cell pertussis vaccine [0.03%]
第四代国际标准百日咳菌体疫苗的评价
R Gaines Das,P Newland,C Asokanathan et al.
R Gaines Das et al.
Whole cell pertussis vaccine is still widely used in many countries. An International Standard is needed for its potency control. The Third International Standard for Pertussis Vaccine was prepared about 40 years ago and its replacement was...
The long term immunological response of swine after two exposures to a salmon thrombin and fibrinogen hemostatic bandage [0.03%]
猪两次暴露于大麻哈鱼凝血酶和纤维蛋白原止血带后的长期免疫反应
Stephen W Rothwell,Timothy Settle,Shannon Wallace et al.
Stephen W Rothwell et al.
Experimental salmon thrombin/fibrinogen dressings have been shown to provide effective hemostasis in severe hemorrhage situations. The hypothesis for this study was that swine would still remain healthy without coagulopathy six months after...
Meeting report on protein particles and immunogenicity of therapeutic proteins: filling in the gaps in risk evaluation and mitigation [0.03%]
蛋白颗粒与治疗性蛋白免疫原性的会议报告：风险评估和缓解中的不足之处
John Carpenter,Barry Cherney,Anthony Lubinecki et al.
John Carpenter et al.
This meeting was successful in achieving its main goals: (1) summarize currently available information on the origin, detection, quantification and characterization of sub-visible particulates in protein products, available information on t...
Applicability of bacterial endotoxins test to various blood products by the use of endotoxin-specific lysates [0.03%]
利用内毒素特异性裂解物对各种血液制品进行细菌内毒素试验的适用性研究
Masaki Ochiai,Akihiko Yamamoto,Seishiro Naito et al.
Masaki Ochiai et al.
Endotoxin contamination is a serious threat to the safety of parenteral drugs, and the rabbit pyrogen test has played a crucial role in controlling this contamination. Although the highly sensitive endotoxin test has replaced the pyrogen te...
Donald P Francis
Donald P Francis
The impact that vaccines have had on world health has been great. The misery prevented and the lives saved have been impressive. But all has not been good. As one looks at the success, one can also see the missed opportunities. This discuss...
Coexpression of double or triple copies of the rabies virus glycoprotein gene using a 'self-cleaving' 2A peptide-based replication-defective human adenovirus serotype 5 vector [0.03%]
采用基于“自我切割”2A肽的复制缺陷型人5型腺病毒载体同时共表达狂犬病病毒糖蛋白双拷贝或三拷贝
Yeping Tan,Hongru Liang,Aie Chen et al.
Yeping Tan et al.
Rabies virus glycoprotein (RVG) is a major structural protein and antigen of rabies virus that induces a highly immunogenic response. In the present study, we have used 2A self-cleaving sequence of the foot-and-mouth disease virus (FMDV) to...
Mode of action of adjuvants: implications for vaccine safety and design [0.03%]
佐剂的作用机制：对疫苗安全性和设计的启示
Béatris Mastelic,Sohail Ahmed,William M Egan et al.
Béatris Mastelic et al.
For decades, the search for new vaccine adjuvants has been largely empirical. A series of new adjuvants and related formulations are now emerging that are acting through identified immunological mechanisms. Understanding adjuvant mechanism ...
Collaborative study for the calibration of a replacement international standard for diphtheria toxoid adsorbed [0.03%]
白喉类毒素吸附国际标准替代品校准的协作研究
Paul Stickings,Peter Rigsby,Laura Coombes et al.
Paul Stickings et al.
We present the results of a collaborative study for the characterization of a preparation of diphtheria toxoid adsorbed, and its calibration in terms of the 3rd International Standard (IS) for Diphtheria Toxoid Adsorbed. Calibration was per...