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Calibration of Ph. Eur. BRP batch 4 for oral poliomyelitis vaccine (OPV)
the collaborative study to calibrate the candidate BRP (cBRP), a commercial trivalent OPV containing live attenuated poliovirus types 1, 2 and 3 (Sabin strain), against the WHO 2nd International ...
Validation of a new ELISA method for in vitro potency testing of hepatitis A vaccines
hepatitis A virus antigen content in hepatitis A vaccines(HAV) marketed in Europe. This became necessary due to issues with the method used previously, requiring the use of commercial test kits. The selected ...
PFAS determination in fish by UPLC-MS/MS
numerous industrial and commercial applications. Due to the large human exposure, the European Union encourages member states to develop methods for the monitoring of PFAS in food (2010/161/ EU). A method ...
Design of multiplex assays for molecular subtyping of pathogens with the Luminex xMAP technology
and cost of experimentation.We have compared two commercial software packages for the development and in silico simulation of a ligation dependent amplification (LDA) assay and a direct hybridization ...
Genotoxicity of water extracts from hypoxis species
and H. acuminata and from a commercial preparation thereof using the neutral red uptake (NRU) assay, the alkaline comet assay and the cytome assay in human hepatoma HepG2 cells. The relative ...
Comparative study of five commercial kits for DNA extraction from urine samples.
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. El Bali; Nancy Roosens; Sigrid C.J. De Keersmaecker Source: WIV-ISP, Brussels, p.15 (2012) ISBN: D/2012/2505/69 Keywords: Comparative Study Dna DNA extraction kit ...
New GMO events on the regulation and commercialization pipeline: challenges for the GMO detection
Publication Type: Scientific poster, presentation or proceeding Authors: N. Papazova; WIV-ISP Source: Workshop NRL-GMO, Issue =IPH (2010) Keywords: challenge CHALLENGES Commercialization detection ...
Intake of dioxins and dioxin-like PCBs consuming home produced eggs versus commercial eggs.
Publication Type: Scientific poster, presentation or proceeding Authors: Sioen,I.; Bilau,M.; Ilse Van Overmeire; G. Eppe; Nadia Waegeneers; L. Pussemier; S. De Henauw; Goeyens,L.; Stuart Harrad Source: 28th International Symposium on Halogenated Environme ...
Guidelines for molecular characterisation of genetically modified higher plants for a standard part B consent according to Annex III B of Directive 2001/18/EC
commercial release of a genetically modified (GM) plant, require information for risk assessment, including molecular data. In carrying out its assessments, the SBB has noted a variation among dossiers in both ...
Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mindset of the manufacturer.
sometimes a lengthy process. Sometimes more than one year should be taken into account between the intention of putting a vaccine on the market and the first available commercial batch. Since OCABR in EU is ...