Search results - 14 results
Calibration of Ph. Eur. BRP batch 4 for oral poliomyelitis vaccine (OPV)
for the quality control (QC) of polio vaccines. Stocks of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) batch 3 for the assay of OPV are dwindling and therefore ...
Collaborative study for the establishment of the human immunoglobulin for electrophoresis Ph. Eur. BRP batch 3
to the diminished stocks of the 2nd batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for human immunoglobulin for electrophoresis, in 2013, the European Directorate ...
Collaborative study for the establishment of the 2 Ph. Eur. Human Immunoglobulin for Electrophoresis BRP batch 3 3
programme Project Quality routine study TESTING use Users Abstract: The current European Pharmacopoeia (Ph. Eur.) Human immunoglobulin for electrophoresis Biological Reference Preparation (BRP) batch 2 was ...
Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the haracterization of cell banks
Keywords: 2010 a Affect an Animal Area AS Biological Products Case Cell cell culture Cell Line cells Comment consultation Control culture Decision Making Development EVALUATION expertise Group growth guidance ...
Calibration of the human immunoglobulin BRPs for ACA and molecular size (batch 1) and for Fc function and molecular size (batches 1 & 2)
European function healthcare HPLC Human Human immunoglobulin,Biological Reference Preparation,distribution of molecular size,anticomplementary activity,Fc function,biological standardisation,collaborative ...
Calibration of the Ph. Eur. Biological Reference Preparation (BRP) for Tetanus Vaccine (Adsorbed) Batch 3).
Biological ReferencePreparation (BRP) batch 2 and for the WHO 3rd International Standard (IS) for Tetanus toxoid (adsorbed).Two freeze-dried stabilised tetanus vaccine (adsorbed) candidate preparations ...
Establishment of a biological reference preparation for Hepatitis A Vaccine (Inactivated, Non-adsorbed)4425
3 manufacturers as candidate Biological Reference Preparations (BRP s). Thirteen laboratoriesparticipated in the collaborative study. They were asked to use an in vitro ELISA method adapted from ...
Collaborative study for the standardisation of the histamine sensitizing test in mice and the CHO cell-based assay for the residual toxicity testing of acellular pertussis vaccines.1
study, a potency of 7500 IU /vial (International Units per vial) was assigned to the current Ph. Eur. Biological Reference Preparation (BRP) for PT. The results of the study also show that 1) intra- and ...
International collaborative study to establish reference preparations to standardise haemagglutination testing for Anti-A and Anti-B in normal intravenous Immunoglobulins by the direct method
used.The Positive control, Negative control and Limit test preparations were adopted in November 2008 by the Commissionof the European Pharmacopoeia (Ph. Eur.) as Biological Reference Preparations. The same ...
Establishment of the Ph. Eur. BRP for Varicella Vaccine Batch 1227
manufacturers was carried out to establish a common reference material for this purpose and establish a Ph. Eur. Biological Reference Preparation. Two candidate reference preparations (X and Y), obtained from ...