Selected article for: "human immune cell and immune cell"
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

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