Establishment of a replacement batch for the Ph. Eur. Heparin low-molecular-mass for calibration CRS [0.03%]
《欧洲药典》肝素低分子量批次校准替代品的建立
A Costanzo,J Hogwood
A Costanzo
The European Pharmacopoeia (Ph. Eur.) prescribes that low-molecular-mass heparin products be calibrated for their molecular mass distribution using a reference preparation with a defined molecular mass calibration. Heparin low-molecular-mas...
Collaborative study for the establishment of Ph. Eur. Biological Reference Preparation for Human tetanus immunoglobulin batch 2 [0.03%]
人破伤风免疫球蛋白第二批欧洲药典适应性生物参考品协作研究
S Jouette,D Le Tallec,A Niewiadomska-Cimicka et al.
S Jouette et al.
A study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) to establish a replacement batch for the current European Pharmacopoeia (Ph. Eur.) Human Anti-D immunoglobulin Biological ...
B Cowper,D Le Tallec,A Costanzo
B Cowper
Here we report the outcome of a collaborative study aimed at demonstrating the suitability of the candidate Chemical Reference Substance (CRS) as a replacement reference (batch 2) for the physicochemical methods in European Pharmacopoeia mo...
Establishment of hepatitis A virus coating reagent batch 2 for in vitro potency assay of hepatitis A vaccines by ELISA [0.03%]
建立一种甲型肝炎病毒包被试剂批号2用于体外ELISA法测定甲型肝炎疫苗效价
S Morgeaux,I Manniam,D Le Tallec et al.
S Morgeaux et al.
The European Pharmacopoeia (Ph. Eur.) prescribes that hepatitis A vaccine (HAV) batches be tested for their potency before being released onto the European market. An enzyme-linked immunosorbent assay (ELISA) method for determination of ant...
Collaborative study for the establishment of Golimumab Biological Reference Preparation Batch 1 [0.03%]
戈利木单抗生物参考品第一批次的确立协作研究
M Wadhwa,P Rigsby,M-E Behr-Gross
M Wadhwa
A candidate preparation of the fully human anti-tumour necrosis factor (TNF) monoclonal antibody golimumab was formulated and lyophilised at the Medicines and Healthcare products Regulatory Agency (MHRA) prior to evaluation in a collaborati...
Validation of an ELISA method for determination of physical particle titre of AAV2-based vector preparations [0.03%]
AAV2载体物理颗粒滴度测定的ELISA方法验证
A Costanzo,E Regourd,V Ridoux
A Costanzo
Recombinant adeno-associated viruses (AAV) are widely used as gene therapy vectors in human gene therapy. Reliable and accurate quantification of the physical particle titre is one of the parameters to be determined for precise dosing, whic...
Collaborative Study for the Calibration of the Ph.Eur. Prekallikrein Activator in Albumin Biological Reference Preparation batches 8, 9 and 10 [0.03%]
人血清白蛋白生物参考物第8、9和10批前期颗粒凝集素活性协作定值研究
C Kefeder,S Eichmeir,D Le Tallec et al.
C Kefeder et al.
An international collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) to calibrate replacement batches for the current European Pharmacopoeia (Ph. Eur.) Prekallikr...
Collaborative study for the characterisation of the BINACLE Assay for in vitro detection of tetanus toxicity in toxoids - Part 1 [0.03%]
用于破伤风类毒素中破伤风毒性体外检测的Binacle试验表征协作研究第一部分
H Behrensdorf-Nicol,B Krämer,D Le Tallec et al.
H Behrensdorf-Nicol et al.
For several decades the European Pharmacopoeia monographs Tetanus vaccine (adsorbed) (0452) and Tetanus vaccine for veterinary use (0697) required that Specific toxicity and Absence of toxin and irreversibility of the toxoidof each bulk of ...
Collaborative study for the characterisation of the BINACLE Assay for in vitro detection of tetanus toxicity in toxoids - Part 2 [0.03%]
用于破伤风类毒素中破伤风毒性体外检测的BINACLE试验表征合作研究-第二部分
H Behrensdorf-Nicol,D Le Tallec,N Sinitskaya et al.
H Behrensdorf-Nicol et al.
Tetanus vaccines for human and veterinary use are produced by formaldehyde-induced inactivation of tetanus neurotoxin (TeNT) purified from Clostridium tetani cultures. Due to the high morbidity caused by exposure to TeNT it is essential tha...
Joint WHO/EDQM Collaborative study for the establishment of WHO 3rd International Standard and Ph. Eur. Biological Reference Preparation for Prekallikrein activator in albumin batch 7 [0.03%]
世卫组织/欧洲药典委员会联合协作研究建立第3国际标准和欧洲药典生物参考试剂（批号7）血浆前激酶促活性物测定人血清白蛋白制品的研究报告
B Fox,E Regourd,P Rigsby et al.
B Fox et al.
An international collaborative study was jointly organised by the World Health Organization (WHO) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish the WHO 3rd International Standard (IS) for Prekall...