Selected article for: "high virus production and virus production"
Author: Okeke, Malachy I.; Okoli, Arinze S.; Diaz, Diana; Offor, Collins; Oludotun, Taiwo G.; Tryland, Morten; Bøhn, Thomas; Moens, Ugo
Title: Hazard Characterization of Modified Vaccinia Virus Ankara Vector: What Are the Knowledge Gaps?
  • Document date: 2017_10_29
    • ID: 175igdfk_26
    Snippet: Since MVA is subjected to selection pressure (multiple multiplication cycles) during production of a high titer virus stock intended for vaccination, it is essential to examine the genome stability of the virus across MSV + 1 to MSV + 5 in human cell lines and in immune-competent and immunecompromised animal models. At present, this information is not provided in ERA dossiers submitted for clinical trials or MAA because relevant EU directive (Dir.....
    Document: Since MVA is subjected to selection pressure (multiple multiplication cycles) during production of a high titer virus stock intended for vaccination, it is essential to examine the genome stability of the virus across MSV + 1 to MSV + 5 in human cell lines and in immune-competent and immunecompromised animal models. At present, this information is not provided in ERA dossiers submitted for clinical trials or MAA because relevant EU directive (Directive 2001/18/EC) has not made the provision of such data obligatory. Data on evolution of MVA in permissive cells during Good Manufacturing Practice (GMP) manufacturing will enable risk assessors to evaluate the genome stability of MVA and the presence of variants in the production batch intended for vaccination. The

    Search related documents:
    Co phrase search for related documents
    • MSV virus genome stability examine and MVA genome stability: 1
    • MSV virus genome stability examine and production batch: 1
    • MSV virus genome stability examine and relevant EU directive: 1
    • MSV virus genome stability examine and selection pressure: 1
    • MVA evolution and production batch: 1
    • MVA evolution and relevant EU directive: 1
    • MVA evolution and selection pressure: 1
    • MVA evolution and virus genome stability: 1
    • MVA genome stability and production batch: 1, 2, 3
    • MVA genome stability and relevant EU directive: 1
    • MVA genome stability and selection pressure: 1
    • MVA genome stability and virus genome stability: 1
    • permissive cell and selection pressure: 1
    • production batch and relevant EU directive: 1
    • production batch and selection pressure: 1
    • production batch and virus genome stability: 1
    • relevant EU directive and selection pressure: 1
    • relevant EU directive and virus genome stability: 1
    • selection pressure and virus genome stability: 1, 2