Search results - 13 results

Report on the collaborative study for the standardization of D-Ag potency assays for inactivated polio vaccines made with Sabin live-attenuated poliovirus strains

Keywords: biological reference preparation collaborative study D antigen European Pharmacopoeia in vitro assay poliomyelitis vaccine (inactivated) Health Topics:  Infantile paralysis Kinderverlamming ...

European Pharmacopoeia biological reference preparation for poliomyelitis vaccine (inactivated)

Bio&SN, Issue December, Number 149, Strasbourg, France, p.16 (2016) Accession Number: NA Keywords: poliomyelitis vaccine (inactivated); D antigen; biological reference preparation; European Pharmacopoeia; ...

Collaborative study for the calibration of the Ph. Eur. prekallikrein activator in albumin BRP batches 4, 5 and 6

Eur.) prekallikrein activator (PKA) in albumin biological reference preparation (BRP), whose stocks were dwindling. The study was run in the frameworkof the Biological Standardisation Programme (BSP) of ...

Establishment of hepatitis A vaccine (inactivated, non-adsorbed) BRP batches 2 and 3

Eur.) Biological Reference Preparation (BRP) is used for the in vitro potency assay of HAV as prescribed by the Ph. Eur. general chapter 2.7.14 Assay of hepatitis A vaccine. This reference preparation was ...

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 ...

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