Elaborating European Pharmacopoeia monographs for biotherapeutic proteins using substances from a single source [0.03%]
利用单一来源物质详细阐述人用生物治疗蛋白质欧洲药典标准草案
M Buda,S Wicks,E Charton
M Buda
For more than twenty years, the European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutic proteins have been elaborated using the multisource approach (Procedure 1), which has led to robust quality standards for many of the first-gene...
Collaborative study for the establishment of the Ph. Eur. Hepatitis E virus RNA for NAT testing biological reference preparation batch 1 [0.03%]
人用药品注册技术要求国际协调会HEV核酸测定生物参考品协作研究课题第1批批次号Ph. Eur._HEVRNA_01的研究报告
S A Baylis,E Terao,J Blümel et al.
S A Baylis et al.
A new European Pharmacopoeia (Ph. Eur.) biological reference preparation (BRP) had to be established further to the decision to include nucleic acid testing (NAT) for the detection of hepatitis E virus (HEV) RNA in the monograph Human plasm...
Calibration of the Ph. Eur. human coagulation Factor VIII concentrate BRP batch 5 [0.03%]
人凝血因子VIII参考品（批号5）标化研究报告
S Raut,A Costanzo,A Daas et al.
S Raut et al.
The European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for Factor VIII Concentrate batch 5 was established through a collaborative study involving 14 laboratories organised by the European Directorate for the Quality of ...
Interpretation of size-exclusion chromatography for the determination of molecular-size distribution of human immunoglobulins [0.03%]
尺寸排阻色谱法测定人免疫球蛋白分子大小分布的探讨
S Christians,S Schluender,N D van Treel et al.
S Christians et al.
Molecular-size distribution by size-exclusion chromatography (SEC) [1] is used for the quantification of unwanted aggregated forms in therapeutic polyclonal antibodies, referred to as human immunoglobulins (Ig) in the European Pharmacopoeia...
Collaborative study for the calibration of replacement batches for the heparin low-molecular-mass for assay biological reference preparation [0.03%]
肝素低分子量测定用生物参考标准品替代批的校准协作研究
E Terao,A Daas
E Terao
The European Pharmacopoeia (Ph. Eur.) prescribes the control of the activity of low molecular mass heparins by assays for anti-Xa and anti-IIa activities (monograph 0828), using a reference standard calibrated in International Units (IU). A...
Collaborative study for the validation of an improved HPLC assay for recombinant IFN-alfa-2 [0.03%]
重组干扰素-α-2高效液相色谱测定法的验证协作研究
K H Jönsson,A Daas,K H Buchheit et al.
K H Jönsson et al.
The current European Pharmacopoeia (Ph. Eur.) texts for Interferon (IFN)-alfa-2 include a nonspecific photometric protein assay using albumin as calibrator and a highly variable cell-based assay for the potency determination of the protecti...
Transferability study of CHO cell clustering assays for monitoring of pertussis toxin activity in acellular pertussis vaccines [0.03%]
百日咳疫苗中百日咳毒素活性检测CHO细胞凝聚试验的适用性研究
R Isbrucker,A Daas,L Wagner et al.
R Isbrucker et al.
Current regulations for acellular pertussis (aP) vaccines require that they are tested for the presence of residual or reversion-derived pertussis toxin (PTx) activity using the mouse histamine sensitisation test (HIST). Although a CHO cell...
Alternatives to HIST for acellular pertussis vaccines: progress and challenges in replacement [0.03%]
替代百日咳疫苗中的白喉类毒素：进展与挑战
J Arciniega,L Wagner,R Prymula et al.
J Arciniega et al.
The 'International Workshop on Alternatives to the Murine Histamine Sensitization Test for Acellular Pertussis Vaccines: Progress and Challenges in the Replacement of HIST' was held on 24 August 2014, in Prague, Czech Republic, as a satelli...
Alternative to Ph. Eur. pour-plate method for detection of microbial contamination in non-sterile pharmaceutical preparations [0.03%]
非无菌制剂微生物限度检查倾注法的替代方法研究
A Palicz,A Paul,A Hofmann et al.
A Palicz et al.
The current European Pharmacopoeia (Ph. Eur.) texts for Interferon (IFN)-alfa-2 include a nonspecific photometric protein assay using albumin as calibrator and a highly variable cell-based assay for the potency determination of the protecti...
Collaborative study for the establishment of erythropoietin BRP batch 4 [0.03%]
人促红素生物参考品第4批协作定值研究报告
C Burns,A F Bristow,A Daas et al.
C Burns 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 the Ph. Eur. monograph Er...