K Steven Cook,Kevin Bullock,Timothy Sullivan
K Steven Cook
N-linked glycosylation can influence the biological activity and safety of an antibody as well as be a measure of the consistency of the production process. The released N-glycans is an important part of the development of a therapeutic ant...
Ivo Laidmäe,Jevgenia Belozjorova,Evelyn S Sawyer et al.
Ivo Laidmäe et al.
Fibrin sealants and topical thrombin preparations are often used for haemostatic and sealing applications in clinical practice. Some of these preparations contain coagulation factors from bovine sources. To minimize the risk of infection an...
Evaluation of a Rapid Immunochromatographic Diagnostic Test for the detection of rabies from brain material of European mammals [0.03%]
评估一种快速免疫层析诊断试验检测欧洲哺乳动物大脑组织中狂犬病毒的能力
Alexandre Servat,Evelyne Picard-Meyer,Emmanuelle Robardet et al.
Alexandre Servat et al.
The surveillance of rabies relies on investigations conducted on dead suspected animals or animals showing clinical signs suggestive of rabies. An immunochromatographic method based on lateral flow principle has been evaluated against a col...
Application of deglycosylation to SDS PAGE analysis improves calibration of influenza antigen standards [0.03%]
应用脱糖基技术改善SDS-PAGE分析以提高流感抗原标准品的标定效果
Ruth Harvey,Michelle Hamill,James S Robertson et al.
Ruth Harvey et al.
Each year the production of seasonal influenza vaccines requires antigen standards to be available for the potency assessment of vaccine batches. These are calibrated and assigned a value for haemagglutinin (HA) content. The calibration of ...
A need for careful evaluation of endotoxin contents in acellular pertussis-based combination vaccines [0.03%]
亟需仔细评估无细胞百日咳联合疫苗中的内毒素含量
Michiyo Kataoka,Masaki Ochiai,Akihiko Yamamoto et al.
Michiyo Kataoka et al.
Two batches each of diphtheria-tetanus-acellular pertussis vaccine (DTaP) and that combined with inactivated polio vaccine purchased from foreign markets were tested by mouse body weight decreasing (BWD) toxicity test and Limulus amaebocyte...
Zuben E Sauna,Gouri Shankar Pandey,Nisha Jain et al.
Zuben E Sauna et al.
The infusion of plasma-derived or recombinant factors to treat bleeding disorders such as hemophilia A and B is a success story in the management of a chronic disease. The effectiveness of this approach is however limited by challenges with...
Johanna C Wiersum-Osselton,Tanneke Marijt-van der Kreek,Wim L A M de Kort
Johanna C Wiersum-Osselton
Donor vigilance is the systematic monitoring of adverse reactions and incidents in blood donor care with a view to improving quality and safety for blood donors. Standard international definitions are available for surveillance purposes. In...
Derivation of non-infectious envelope proteins from virions isolated from plasma negative for HIV antibodies [0.03%]
用血源性HIV抗体阴性病毒颗粒分离物制备非感染性包膜糖蛋白分子复合物及其制剂
Girish N Vyas,Cheryl A Stoddart,M Scott Killian et al.
Girish N Vyas et al.
Natural membrane-bound HIV-1 envelope proteins (mHIVenv) could be used to produce an effective subunit vaccine against HIV infection, akin to effective vaccination against HBV infection using the hepatitis B surface antigen. The quaternary ...
Development of a fast ELISA for quantifying polio D-antigen in in-process samples [0.03%]
一种快速测定生产过程样本中脊灰D型抗原的ELISA方法的建立
R ten Have,Y E Thomassen,M R J Hamzink et al.
R ten Have et al.
A fast ELISA was developed and qualified for analysis of polio D-antigen. The original 20 h-protocol was optimized by minimizing the total incubation time to 1 h, and by replacing the signal reagent 3,3',5,5'-tetramethylbenzidine by a chemi...
Jay S Epstein
Jay S Epstein
The need for blood regulation arises from the inherent risks of blood transfusion, which are minimized through implementation of standards. Regulatory oversight is advocated by the World Health Organization (WHO) as an essential element of ...