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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 ...
The vaccine Batch release procedure in Europe
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Seminaire ULB Pharmacien d'industrie, ULB, ULB pharmacie (2022) Keywords: batch release Europe OMCL ...
Proposal for 3R reporting for Official Control Authority Batch Release
Publication Type: Scientific poster, presentation or proceeding Authors: Source: OMLC Annual meeting 2021- Common OCABR session, EDQM (extranet), Strasbourg, France (2021) Keywords: 3Rs EU reporting Vaccine quality control Health Topics: Effectiveness an ...
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. ...
Expertise activities: participation in licensing procedures for vaccines and plasma-derived products
Publication Type: Scientific poster, presentation or proceeding Authors: Koen Brusselmans Source: Quality control and batch release of vaccines and blood products in Europe, NA, Issue WIV-ISP, NA ...
The Quality Control of Plasma-Derived Medicinal Products
Publication Type: Scientific poster, presentation or proceeding Authors: O. Carabin; Geneviève Waeterloos Source: Quality control and batch release of vaccines and blood products in Europe, NA, ...
Quality control and batch release in practice: Belgian OMCL and polio eradication
Publication Type: Scientific poster, presentation or proceeding Authors: M Janssen Source: Quality control and batch release of vaccines and blood products in Europe, NA, Issue WIV-ISP, NA (2015) ...
Testing of expired Synflorix bulks: actions taken by three OMCLs and concerns raised by another OMCL.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Brussels, Belgium (2015) Keywords: batch release meeting TESTING ...