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Zoekresultaten - 25 results
Release of nano-objects, aggregates and agglomerates from masks (RENAAME): Detection of release in aerosol phase
of masks and for evaluating the release of these nanoparticles in the aerosol phase. This communication details the first results of the third phase of the project, which aims to develop test benches ...
Advanced Analysis of Biopharmaceuticals: Endotoxin content & Sterility testing
Vaccines and other Biologics 9-12 December, 2024, virtual Webinair, EMA, virtual (2024) Keywords: Vaccine- OMCL- lot release Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot ...
Release of Nano-objects, their aggregates and agglomerates from Masks (RENAAME): validation of a screening method to identify Ti and Ag elements in masks
elements masks nanomaterials Abstract: The objective of the RENAAME project (Release of Nano-objects, their Aggregates and Agglomerates (NOAA) from Masks), supported for 3 years by ANSES and coordinated by ...
Implementing the 3RS in quality Control and batch release testing- view from a Belgian OMCL
Publication Type: Scientific poster, presentation or proceeding Authors: Florens, M.; Tesolin, L. Source: AFMPS- Advancing the 3Rs for Regulatory Testing of Medicines-31/01/2024-Antwerpen, Belgium, ...
Validation of an animal-free analytical method for the detection of bacterial endotoxins in human vaccines
“Official Control Authority Batch Release” (OCABR) guidelines, is entitled to check the concentration of endotoxin in bacterial vaccines. The limulus amebocyte lysate (LAL) and the recombinant factor C (rFC) ...
Determination of vaccine bacterial endotoxins content by the rFC method
factor c; LAL Abstract: Sciensano, as official medicines control laboratory (OMCL) following “Official Control Authority Batch Release” (OCABR) guidelines, is entitled to check the concentration of ...
Regulatory expectations on the use of vaccine reference standards for maintaining product quality.
clinical batches that were shown to be safe and efficacious. In any case, when standards are being qualified, the set of release tests should be accompanied by a set of additional characterization assays. ...
Panel discussion official forum Taiwan FDA to share/discuss about COVID-19 vaccine testing, medicines quality issues, and batch release procedures
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Taiwan FDA to share/discuss about COVID-19 vaccine testing, medicines quality issues, and batch release ...
Development of a multiplex immunoassay for simultaneous detection of antigens in DTaP vaccines
Virtual (2021) Keywords: 3R Vaccine Potency Abstract: Routine batch quality testing before vaccine release, notably for potency evaluation, still relies on animal use for several animal and human vaccines. ...
Release of trace elements from enameled table- and cookware: comparison of test conditions
Publication Type: Scientific poster, presentation or proceeding Authors: Heidi Demaegdt; Karlien Cheyns Source: Ad hoc WG on enamelled food contact materials and articles, Issue Council of Europe (2020) Health Topics: Food consumption and food safety Con ...