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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.

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 obligatory, ...

Screening for nanoparticles in complex matrices within a regulatory framework: are we there yet?

coating of confectionery, for decoration of chocolates, and in liqueurs. It is commercially distributed in its pristine powder and sheet form, and in confectionary products. The presented work is part of ...

Appoaching EMA and National regulatory authorties: who, when and how.

Publication Type: Scientific poster, presentation or proceeding Authors: W. Van Molle Source: 2017 Vaccines Bioprocess Development & Commercialization Workshop, MIT Center for Biomedical ...

Panel discussion on CMC for vaccines: "Responding in Time: Dealing with Predictable and Unpredictable"

Publication Type: Scientific poster, presentation or proceeding Authors: W. Van Molle Source: 2017 Vaccines Bioprocess Development & Commercialization Workshop, MIT Center for Biomedical ...

Occurrence of polybrominated diphenyl ethers and emerging halogenated flame retardants in food items

silica Target TBA use values variety Vegetable Abstract: Brominated flame retardants (BFR s) are chemicals used in a wide range of commercial and household products in order to reduce their flammability. ...

Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.

between the intention of putting a vaccine on the market and the first available commercial batch, aside from the development of the product and the Marketing Authorization (MA) process. Since OCABR in EU ...

Biological activity conferred by endocrine disrupting chemicals in hospital effluent and river water from the Brussels Region, Belgium

hospital effluent and, respectively, 52.3 and 1.2ng EEQ /L for WWTP influent and effluent. For comparison reasons, commercial drinking waters amount to 0.004-0.070 ng EEQ /L. These results indicate that ...

PFAS determination in fish by UPLC-MS/MS

properties of per and polyfluorinated compounds (PFAS) make these synthetic substances widely used in numerous industrial and commercial applications. Due to the large human exposure, the European Union ...

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 ...

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