Effectiveness of Brucella abortus lipopolysaccharide as an adjuvant for tuberculin PPD [0.03%]
布鲁氏菌脂多糖作为结核菌素PPD佐剂的效果研究
Mostafa Jamalan,Susan Kaboudanian Ardestani,Majid Zeinali et al.
Mostafa Jamalan et al.
Bacterial lipopolysaccharide (LPS) has T-helper 1 (Th1) immunostimulatory activities but because of toxicity and pyrogenicity cannot be used as an adjuvant. Brucella abortus LPS has less toxicity and no pyrogenic properties in comparison to...
Comparability assessments of process and product changes made during development of two different monoclonal antibodies [0.03%]
两种不同的单克隆抗体在开发过程中对工艺和产品变更进行比较评估的方法
Anthony Lubiniecki,David B Volkin,Marcia Federici et al.
Anthony Lubiniecki et al.
To assess the impact of manufacturing changes on antibody structure and function during the course of product development, three comparability studies were performed for each of two different IgG1 monoclonal antibody product candidates. Com...
A two-stage, multilevel quality control system for serological assays in anthrax vaccine clinical trials [0.03%]
一种两阶段、多层次的质量控制体系在炭疽疫苗临床试验中的血清学检测中的应用
Stephen D Soroka,Jarad M Schiffer,Vera A Semenova et al.
Stephen D Soroka et al.
A two-stage, multilevel assay quality control (QC) system was designed and implemented for two high stringency QC anthrax serological assays; a quantitative anti-PA IgG enzyme-linked immunosorbent assay (ELISA) and an anthrax lethal toxin n...
Capacity of the manufacturing process of Flebogamma(®) DIF, a new human high purity intravenous immunoglobulin, to remove a TSE model-agent [0.03%]
Flebogamma(®) DIF人血浆高纯度静脉注射用免疫球蛋白生产工艺去除TSE模型病原的能力研究
José M Diez,Santiago Caballero,Francisco Belda et al.
José M Diez et al.
The variant Creutfeldt-Jakob disease (vCJD) is a transmissible spongiform encephalopathy (TSE) associated with the ingestion of cattle derived products affected with bovine spongiform encephalopathy. vCJD emerged in the UK, where most of th...
Intravenous administration of equine-derived whole IgG antivenom does not induce early adverse reactions in non-envenomed horses and cows [0.03%]
马血清全免疫球蛋白抗蛇毒制剂静脉给药对未被 snakes venom 掺毒的马和牛不产生早期不良反应
Ricardo Estrada,María Herrera,Alvaro Segura et al.
Ricardo Estrada et al.
Administration of antivenoms to treat snakebite envenomings has the potential risk of inducing early adverse reactions. The mechanisms involved in these reactions are unclear. In this study, polyspecific antivenom consisting of whole IgG pu...
Domain III peptides from flavivirus envelope protein are useful antigens for serologic diagnosis and targets for immunization [0.03%]
黄病毒包膜蛋白的III型结构城肽是血清学诊断有用的抗原和免疫接种的目标
Juliana Helena Chávez,Jaqueline Raymondi Silva,Alberto Anastacio Amarilla et al.
Juliana Helena Chávez et al.
The Flavivirus genus of the Flaviviridae family includes 70 enveloped single-stranded-RNA positive-sense viruses transmitted by arthropods. Among these viruses, there are a relevant number of human pathogens including the mosquito-borne den...
Enhanced potency of individual and bivalent DNA replicon vaccines or conventional DNA vaccines by formulation with aluminum phosphate [0.03%]
磷铝化合物可增强DNA复制子疫苗或传统DNA疫苗的个体和二聚活性
Yun-Zhou Yu,Wen-Bin Wang,Na Li et al.
Yun-Zhou Yu et al.
DNA vaccines against botulinum neurotoxin (BoNTs) induce protective humoral immune responses in mouse model, but when compared with conventional vaccines such as toxoid and protein vaccines, DNA vaccines often induce lower antibody level an...
Excipient exchange in the comparison of preparations of the same biologic made by different manufacturing processes: an exploratory study with recombinant human growth hormone (rhGH) [0.03%]
不同生产工艺制备的相同生物药制剂对比中的辅料交换：重组人生长激素(rhGH)的探索性研究
Mike Cauchy,Mary Alice Hefford
Mike Cauchy
Demonstrations of bio-similarity between subsequent entry (follow-on) biologics and innovator's formulated drug products may depend upon methods that either remove excipients completely or allow the exchange of excipients to give equivalent...
Application of the Three Rs to challenge assays used in vaccine testing: tenth report of the BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement [0.03%]
有关优化疫苗检测用挑战模型的“3R”应用的报告：英国兽医学院/帧有限公司/皇家防止残酷对待动物协会/大学基金会反虐待动物协会联合工作组第10份报告
Maggy Jennings,David B Morton,Emmanuelle Charton et al.
Maggy Jennings et al.
This report aims to facilitate the implementation of the Three Rs (reduction, refinement and replacement) in the testing of vaccines for regulatory and other purposes. The focus is predominantly on identification of reduction and refinement...