Search results - 77 results

Development of a monoclonal antibody sandwich ELISA for the determination of antigen content and quality in diphtheria vaccines.

Paul Source: ALTEX, Volume 41, Issue 1 (2024) Keywords: Antibodies, Monoclonal Diphtheria Diphtheria Toxoid Enzyme-Linked Immunosorbent Assay Humans Tetanus Toxoid vaccines Abstract: At present, quality ...

Multicenter interlaboratory study of routine systems for the susceptibility testing of temocillin using a challenge panel of multidrug-resistant strains.

treating infections caused by multidrug-resistant Enterobacterales. This multicenter study aimed to investigate the performance of routine temocillin testing assays against Enterobacterales challenging ...

Microbial quality analysis of falsified medicines seized by controling agencies

refers to the amount and type of microorganisms present in a sample and reflects the level of biological contamination and associated potential health risks upon consumption of the product. We initially ...

Pyrogen testing of phage therapeutic products

amoebocyte lysate (LAL) assay and the animal-friendly alternative, the recombinant factor C (rFC) test. However, other (non-endotoxin) pyrogenic substances including compounds of the gram-positive bacterial ...

Validation of an animal-free analytical method for the detection of bacterial endotoxins in human vaccines

assays are suitable for all vaccines tested, although the most appropriate technique of endotoxins quantification depends on the type of vaccine. Health Topics:  Effectiveness and safety of vaccines, ...

Determination of vaccine bacterial endotoxins content by the rFC method

endotoxin in bacterial vaccines. The limulus amebocyte lysate (LAL) and the recombinant factor C (rFC) assays are suitable for all vaccines tested. The rFC method has been implemented at Sciensano for batch ...

Regulatory expectations on the use of vaccine reference standards for maintaining product quality.

should meet all requirements regarding safety and efficacy before its release to the market. The use of (international) reference standards or reference preparations plays a key role in assay validation ...

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

focused on the development of a Luminex-based multiplex assay to monitor the consistency of antigen quantity and quality throughout the production process of DT aP vaccines from two human vaccine ...

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 ...

Development of a Droplet Digital PCR to Monitor SARS-CoV-2 Omicron Variant BA.2 in Wastewater Samples

RT-ddPCR method that targets the T19I amino acid mutation in the spike protein of the SARS-CoV-2 genomes, which is specific to the BA.2 variant (omicron). The T19I assay was evaluated both in silico and in ...

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