Validation of a qPCR method for determination of viral genome titres of AAV2-based vector preparations [0.03%]
用于测定AAV2载体制品滴度的qPCR方法验证
V Ridoux,S Laurens,S Venturini et al.
V Ridoux et al.
The viral genome titre is universally used for the dosing of adeno-associated virus (AAV)-based vectors used for gene therapy. To standardise this determination, the development of a common method would be valuable to facilitate comparison ...
Establishment of Ph. Eur. Hepatitis C Virus RNA for NAT testing BRP batch 2 [0.03%]
人用药品注册技术要求国际协调会乙型肝炎病毒RNA标准品第二批标化研究
G Pisani,D Le Tallec,A Costanzo
G Pisani
The European Pharmacopoeia (Ph. Eur.) monographs Human plasma for fractionation (0853) and Human plasma (pooled and treated for virus inactivation) (1646) require that plasma pools be tested for hepatitis C virus (HCV) RNA presence by nucle...
Assay discrepancies using human coagulation factor VIII chromogenic kits: Results from a plasma-derived factor VIII collaborative study (BSP112) [0.03%]
人源性VIII因子定值血浆中 Factor VIII 活性的色谱法检测结果的差异：参与巴德年会 112 研究的各实验室之间的对比研究
S Raut,A Daas,P Rigsby et al.
S Raut et al.
Chromogenic assay discrepancies were reported at General European Official Medicines Control Laboratories Network (GEON) meetings by laboratories testing FVIII-products. The objectives of the present investigation were to carry out a contro...
Validation of an ELISA method for quantification of the major Timothy grass pollen allergen Phl p 5a (BSP090) [0.03%]
ELISA检测方法的验证用于定量豚草花粉主要过敏原Phl p 5a(BSP090)
J Zimmer,S Schmidt,A Costanzo et al.
J Zimmer et al.
Progress towards standardisation of allergen products has been made in recent years. Nevertheless, no standardised test method to quantify the allergen content of grass pollen allergen products is available at present. One aim of the BSP090...
Collaborative study for the establishment of Ph. Eur. Human immunoglobulin for electrophoresis BRP batch 4 [0.03%]
人免疫球蛋白BRP批4电泳参考品建立协作试验研究报告
M-E Behr-Gross,E Regourd,W Holtkamp
M-E Behr-Gross
Due to the diminished stocks of the third batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human immunoglobulin for electrophoresis, in 2020 the European Directorate for the Quality of Medicines & He...
Establishment of Ph. Eur. Somatropin/desamidosomatropin resolution mixture Chemical Reference Substance batch 2 [0.03%]
人促生长激素/脱乙酰人促生长激素化学对照品第2批的确立
S Jorajuria,M Vees,S Pierre et al.
S Jorajuria et al.
The control of somatropin products according to the monographs of the European Pharmacopoeia (Ph. Eur.) requires a system suitability preparation for the test for related proteins by liquid chromatography. A preparation consisting in a mixt...
Collaborative study for the calibration of Ph. Eur. Heparin Low-Molecular-Mass for Assay Biological Reference Preparation batch 11 [0.03%]
欧洲药典低分子量肝素测定生物参考标准品11批校准协作研究
E Terao,E Regourd
E Terao
European Pharmacopoeia (Ph. Eur.) monograph 0828 prescribes two in vitro assays to evaluate the biological activity of low-molecular-mass heparin products. These assess the capacity of low-molecular-mass heparins to accelerate the inhibitio...
Collaborative study for the establishment of Human immunoglobulin for anticomplementary activity BRP replacement batches 3, 4, 5 and 6 [0.03%]
人免疫球蛋白抗补体活性BRP替代批号3、4、5和6的协作研究
L Miller,Z Waibler,E Regourd et al.
L Miller et al.
Human immunoglobulin products are used for the treatment of a number of diseases, such as primary or secondary immunodeficiencies and autoimmune conditions due to the complete absence of antibodies or the production of defective immunoglobu...
Weighing according to the European Pharmacopoeia: general considerations and new general chapter 2.1.7. Balances for analytical purposes [0.03%]
欧洲药典衡重法：一般考虑及新的通则2.1.7分析天平
K Fritsch,C Saal,B Spieldenner
K Fritsch
Weighing is a key activity in every quality control laboratory as it is one of the first steps in the preparation of samples and reagents for most analytical procedures. It is also critical because weighing errors will add up and propagate ...
Collaborative study for the establishment of Ph. Eur. Human albumin (molecular size) Biological Reference Preparation batches 1, 2 and 3 [0.03%]
人血白蛋白（分子量）生物参考试剂1、2和3批欧典协作研究公告
N Sinitskaya,E Regourd,M Wierer et al.
N Sinitskaya et al.
To comply with European Pharmacopoeia (Ph. Eur.) monograph Human albumin solution (0255), albumin solutions have to be tested for molecular-size distribution by size-exclusion chromatography (SEC). However, differences in interpretation of ...