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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 ...

Calibration of the Ph. Eur. Biological Reference Preparation (BRP) for Tetanus Vaccine (Adsorbed) Batch 3).

World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) to establishreplacement batches for the European Pharmacopoeia (Ph. Eur.) Tetanus Vaccine (adsorbed) ...

Collaborative Study for the Validation of Alternative in vitro Potency Assays for Human Tetanus Immunoglobulin

vivo assay to be performed to determine the potency of human tetanus immunoglobulins during their development. Furthermore, it states that an in vitro method shall be validated for the batch potency ...

Establishment of Replacement Batches for Prekallikrein Activator in Albumin Biological Reference Preparation

current Prekallikrein activator in albumin Biological Reference Preparation (BRP) batch 1, the stocks of which were dwindling. Candidate BRP replacement batch 2 and batch 3 were assayed against the 2nd ...

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