Search results - 6 results
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 ...
"WHO Workshop on Implementation of Guidelines for procedures and data requirements for changes to approved vaccines"
Publication Type: Scientific poster, presentation or proceeding Authors: D. Lei; H. Meyer; T. Jivapaisarnpong; L. Tesolin Source: "WHO Workshop on Implementation of Guidelines for procedures ...
Brief update on Malaria vaccine art 58 OCABR guideline
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Annual OMCL meeting, NA, Issue EDQM, NA (2015) Keywords: Malaria meeting ON vaccine Health Topics: Effectiveness and safety of vaccines, medicines and health prod ...
Development and validation of a targeted LC-MS/MS quantitation method to monitor cell culture expression of tetanus neurotoxin during vaccine production
further upstream purification and detoxification. The quantitation method, validated according to ICH guidelines and by the application of the total error approach, was utilized to assess the amount of TeNT ...
Panel discussion on the adoption of 3Rs and non-animal approaches for quality control and batch release testing of these products
Publication Type: Scientific poster, presentation or proceeding Authors: Geneviève Waeterloos Source: https://www.nc3rs.org.uk/events/nc3rs-workshop-implementing-3rs-who-guidelines ...