Establishment of a candidate equine influenza Florida Clade 2 strain A/eq/Richmond/1/07 horse antiserum as Ph. Eur. Biological Reference Preparation/OIE International Reference Reagent [0.03%]
A/eq/Richmond/1/07马匹抗血清候选流感病毒佛罗里达谱系2型标准株作为欧洲药典生物参考品/世界动物卫生组织国际参考试剂的建立
R Paillot,E Regourd,M-E Behr-Gross
R Paillot
Equine influenza (EI) is an important respiratory disease of horses, with welfare and economic consequences. Vaccination remains one of the most efficient prevention methods available. Equine influenza virus (EIV) is constantly evolving and...
Collaborative study for the validation of cell line assays for in-process toxicity and antigenicity testing of Clostridium septicum vaccine antigens - Part 1 [0.03%]
肉毒杆菌疫苗抗原制备过程中的毒性及抗原性检测的细胞实验验证协作研究（第一部分）
A Daas,M-E Behr-Gross,L Bruckner et al.
A Daas et al.
Large numbers of mice are used in testing during the production of Clostridial vaccines. Previous work has indicated that cell line assays could replace mouse tests for certain aspects of this testing. Replacement assays have been developed...
Collaborative study for the establishment of Infliximab Biological Reference Preparation Batch 1 [0.03%]
英夫利西单抗生物参考标准第一批量建立协作研究
M Wadhwa,P Rigsby,M-E Behr-Gross
M Wadhwa
Two preparations of the chimeric anti-Tumour Necrosis Factor (TNF) monoclonal antibody Infliximab were formulated and lyophilised at the National Institute for Biological Standards & Control (NIBSC) prior to evaluation in a collaborative st...
Collaborative study for the establishment of the 3rd international standard for amphotericin B [0.03%]
制备两性霉素B国际参考标准第三号的协作研究
Sylvie Jorajuria,Manuela Fernandes,Michèle Vees et al.
Sylvie Jorajuria et al.
An international collaborative study was organised to establish the 3rd World Health Organization (WHO) International Standard (IS) for amphotericin B. Sixteen laboratories from different countries participated. Potencies of the candidate m...
Collaborative study for the establishment of the 3rd international standard for erythromycin [0.03%]
红霉素第3国际标准的制定协作研究
Sylvie Jorajuria,Chantal Raphalen,Gwenaëlle Cozic et al.
Sylvie Jorajuria et al.
An international collaborative study was organised to establish the 3rd World Health Organization (WHO) International Standard (IS) for Erythromycin. Fifteen laboratories from different countries participated. Potencies of the candidate mat...
Assessment of methods for determination of glycan composition of erythropoietin [0.03%]
评估用于确定促红细胞生成素寡糖组成的方法的功效
B Cowper,C Burns,A F Bristow et al.
B Cowper et al.
Erythropoietin (EPO) is a monomeric, highly glycosylated, protein hormone (molecular size around 30-35 kD), produced mainly in adult kidneys, which acts principally on red blood cell progenitors and precursors to promote red cell production...
Collaborative study for the establishment of erythropoietin BRP batch 5 [0.03%]
人促红素生物参考品第5批协作定值研究报告
J Ferguson,C J Burns,E Regourd et al.
J Ferguson et al.
The European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for erythropoietin (EPO) is used as a working standard for potency determination of EPO preparations by in vivo bioassay as prescribed in Ph. Eur. monograph 1316 '...
Establishment of an erythropoietin CRS with stable measurable dimer content for SEC system suitability qualification [0.03%]
用于SEC系统适用性鉴定的含稳定可测二聚体含量的促红细胞生成素参比标准品的建立
P Matejtschuk,C Duru,A F Bristow et al.
P Matejtschuk et al.
The European Pharmacopoeia (Ph. Eur.) monograph 1316 'Erythropoietin concentrated solution' prescribes that the dimer content of therapeutic erythropoietin (EPO) preparations must not exceed 2% as determined by Size-Exclusion Chromatography...
Establishment of detection antibodies BRRs batch 5 for in vitro potency assay of hepatitis A vaccines by ELISA [0.03%]
用于体外检测甲肝灭活疫苗效力的抗体检定批5（BRRs Batch 5）的确立
S Morgeaux,A Koy,I Manniam et al.
S Morgeaux et al.
The European Pharmacopoeia (Ph. Eur.) standard ELISA method for determination of antigen content of hepatitis A vaccines (HAV) requires specific coating and detection Biological Reference Reagents (BRRs). The 4th batch of detection antibodi...
Calibration of pertussis toxin BRP batch 1 in a standardised CHO cell-based clustering assay [0.03%]
百日咳毒素BRP批号1的校准——基于CHO细胞聚集的标准化检测方法
K Markey,A Douglas-Bardsley,J Hockley et al.
K Markey et al.
The European Pharmacopoeia (Ph. Eur.) pertussis toxin (PT) Biological Reference Preparation (BRP) is used as a working standard for safety testing of acellular pertussis vaccines as prescribed in the Ph. Eur. monographs 1356 "Pertussis vacc...