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The vaccine Batch release procedure in Europe
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Seminaire etudiants en pharmacie ULB, ULB, Brussels, Belgium (2023) Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Qual ...
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 batch release procedure in Europe
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Seminaire etudiants en pharmacie ULB, ULB, Brussels, Belgium (2022) Keywords: batch release Europe OMCL ...
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. ...
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.
Challenges in Vaccines Supply to Developing Countries, PDA Europe, Issue PDA Europe, Berlin, Germany (2015) Keywords: a abstract approach approaches batch release challenge CHALLENGES conference Countries ...
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 ...