Search results - 64 results

Pyrogen testing of phage therapeutic products

endotoxins, components of the cell wall of gram-negative bacteria which are released upon bacterial lysis.   In our routine phage quality control (QC) workflow, endotoxins are quantified using the Limulus ...

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

3R (2023) Keywords: Endotoxin " vaccine " quality control " recombinant factor c " LAL Abstract: Sciensano, as official medicines control laboratory (OMCL) following ...

Determination of vaccine bacterial endotoxins content by the rFC method

Publication Type: Scientific poster, presentation or proceeding Authors: Flore Laurent Source: NA, OMCL annual meeting Madrid 2023 (2023) Keywords: Endotoxin; vaccine; quality control; recombinant ...

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

standards depend on their intended use. The more international reference standards become available and are used, the more harmonization in quality control by companies and authorities can become a reality. ...

What do we request for production and quality control of CHIM strains.Should it be GMP or is adherence to GMP acceptable?

des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Full text language:  English Category:  Scientific posters, presentations and proceedings ...

Manufacture and control of vaccine adjuvants from OMCL perspective

vaccine Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments et produits de santé- Qualité des ...

The GEONs API-fingerprint program: Tackling falsifications of APIs

casualties happened when altered API s escaped detection in routine analytical testing. Any form of tampering the content or information about the content might affect the quality of the API, the finished ...

Evolution and determinants of glycaemic control in children and adolescents with type 1 diabetes in Belgium: A 10-year period observational real-world study

Source: ISPAD (2022) Abstract: Since 2008 all Belgian paediatric diabetes centres (PDC s) participate to a biennial audit/feedback, allowing to monitor the quality of care given in PDC s and to describe ...

Sustainability in Quality Control of Vaccines: Applying the 3R’s principle and implementing the 4th R.

Challenges", PDA, Amsterdam, The Netherlands (2022) Service:  Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Full text language:  English ...

Proposal for 3R reporting for Official Control Authority Batch Release

Vaccine quality control Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments et produits de ...

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