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DTaP Potency testing: 3R's status
(2024) Keywords: national control laboratory Network Quality vaccine Health Topics: Conformité de lot de vaccin Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten ...
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities.
ever-increasing complexity, diversity, and number of vaccine products as well as increasing efforts to replace animal-based potency tests with in vitro assays that measure relevant quality attributes. As such, ...
Development of a monoclonal antibody sandwich ELISA for the determination of antigen content and quality in diphtheria vaccines.
control of diphtheria vaccines by both manufacturers and national control laboratories relies heavily on in vivo assays to confirm potency. As part of the VAC2VAC project we have developed a monoclonal ...
Regulatory expectations on the use of vaccine reference standards for maintaining product quality.
used for final lot qualification, especially if it is an assay to determine the potency or activity of the vaccine. In the latter case, it is important that the candidate standard has a clear link with ...
Replacement of Diphtheria and Tetanus potency challenge method by serology in mice
Publication Type: Scientific poster, presentation or proceeding Authors: J. Auquier Source: Annual OMCL Meeting 2023, EDQM, Madrid (2023) Keywords: 3R Diphtheria serology Tetanus vaccine Health ...
Development of a multiplex-based immunoassay for the characterization of diphtheria, tetanus and acellular pertussis antigens in human combined DTaP vaccines.
vaccine release, notably for potency evaluation, still relies on animal use for several animal and human vaccines. In this context, the VAC2VAC project is a public-private consortium of 22 partners funded ...
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 ...
Characterisation of tetanus monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay.
Antoine Francotte; Paul Stickings Source: Biologicals, Volume 71 (2021) Keywords: Animal Testing Alternatives Animals Antibodies, Monoclonal Immunoassay Tetanus Tetanus Toxoid Vaccine Potency Abstract: ...
Characterisation of diphtheria monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay.
Volume 69 (2021) Keywords: Antibodies, Monoclonal Diphtheria Diphtheria Toxoid Immunoassay Vaccine Potency Abstract: Immunoassays are used for routine potency assessment of several vaccines, in some cases ...
Report on the collaborative study for the standardization of D-Ag potency assays for inactivated polio vaccines made with Sabin live-attenuated poliovirus strains
Keywords: biological reference preparation collaborative study D antigen European Pharmacopoeia in vitro assay poliomyelitis vaccine (inactivated) Health Topics: Infantile paralysis Kinderverlamming ...