Résultats de la recherche - 15 results

Belgian recommendations for analytical verification and validation of immunohistochemical tests in laboratories of anatomic pathology

analysis taking into account the majority of variables regarding verification/validation of methods have been performed, resulting in an expert consensus recommendation that is a compromise between ...

Pyrogen testing of phage therapeutic products

contamination (e.g. cell wall debris) is a major safety concern as these pro-inflammatory agents can cause unwanted clinical reactions with potential detrimental outcome. The most common and potent pyrogens are ...

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 ...

Homologous versus heterologous prime-boost COVID-19 vaccination: impact on clinical severity of Omicron among hospitalized COVID-19 patients in Belgium

SARS-CoV-2 Omicron infection among hospitalized patients in Belgium, and if this effect is homogenous across different Omicron sub-lineages. Methods Observational data from existing national surveillance ...

The GEONs API-fingerprint program: Tackling falsifications of APIs

API testing within the network is limited, compared to the surveillance of finished products. To tackle the issue of falsified API detection the API-working group (API- WG) of the GEON organizes ...

Praktijkrichtlijn voor het opzetten van een kwaliteitssysteem in de erkende laboratoria voor pathologische anatomie werkzaam binnen het kader van het Erkenningsbesluit

(verstrekkingen) verricht in een laboratorium voor pathologische anatomie, werkzaam binnen het kader van het Erkenningsbesluit pathologische anatomie. Een kwaliteitssysteem is een systemisch en continu proces waarin ...

Development of a multiplex immunoassay for simultaneous detection of antigens in DTaP vaccines

In this context, the VAC2VAC project is a public-private consortium of 22 partners funded by EU. Its main objective is to reduce the number of animal used for batch testing by developing immunoassays ...

Characterization and hazard identification of substandard and falsified antimicrobials encountered in Belgium

spectrometry (UHPLC- MS2) screening method is presented, taking only 15 minutes, for the identification of 36 different antimicrobials and 1 beta-lactamase inhibitor. Furthermore, upon identification, ...

Identification of Flavouring Substances of Genotoxic Concern Present in E-Cigarette Refills

increased significantly. An important contributor to this trend is the availability of a wide variety of flavours used in e-liquid refills. However, the role of these flavouring components in the potential ...

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