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Zoekresultaten - 51 results

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 ...

Development of a multiplex-based immunoassay for the characterization of diphtheria, tetanus and acellular pertussis antigens in human combined DTaP vaccines.

Vaccines Diphtheria-Tetanus-Pertussis Vaccine Humans Hydrogen Peroxide Immunization, Secondary Immunoassay Reproducibility of Results Tetanus Whooping Cough Abstract: Routine batch quality testing before ...

Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over release testing of vaccines.

Issue 1, Number 377 (2023) Abstract: INTRODUCTION: There are rational arguments to replace existing in vivo potency and safety assays for batch release testing of vaccines with more advanced non-animal ...

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. ...

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