Home » Virale vectoren

Virale vectoren

  • 19-08-2025

    Advice Explanation of the COGEM formula for calcu­lating free lentiviral or gammaretroviral vector particles after ex vivo transduction

    In biomedical or clinical research, cells are often genetically modified using lentiv...

    Advisory reports
    CGM/250819-01 View more
  • 20-05-2025

    Advice Reassessment of the threshold values for the presence of free lentiviral and retroviral vector particles in clinical trials with ex vivo transduced cells

    In certain gene therapies, cells from the patient are genetically altered outside the...

    Advisory reports
    CGM/250520-01 View more
  • 17-06-2024

    Advice on the decision by the European Commission on the GMO status of viral replicon particles

    The European Commission (EC) has made a decision on the status of viral replicon part...

    Advisory letters
    CGM/240617-01 View more
  • 31-01-2023

    Detection of replication competent virus formation during production and use of lenti- and gammaretroviral vectors

    COGEM commissioned research on the tests and methods that can be used to demonstrate ...

    Research reports
    CGM 2023-01 View more
  • 31-01-2023

    Research project on detection methods for replication-competent lentiviral and retroviral vectors

    Biomedical, genetic, and clinical research is often carried out with replication-defi...

    Advisory letters
    CGM/230131-01 View more
  • 23-12-2022

    Viral replicon systems and their biosafety aspects –Inventory and description of viral replicon systems and characteristics relevant for risk assessment

    Much attention is being paid to the development and application of viral replicons, b...

    Research reports
    CGM 2022-06 View more
  • 23-12-2022

    Generic downscaling of containment requirements for work with viral replicons derived from alphaviruses and flaviviruses

    Much research is being done on the development and application of ‘viral replicons’. ...

    Advisory reports
    CGM/221223-01 View more
  • 07-05-2020

    Generic environmental risk assessment of gene therapies that use GM cells containing free lentiviral particles

    A generic environmental risk assessment has been prepared for gene therapy trials in ...

    Advisory reports
    CGM/200507-01 View more
  • 11-02-2020

    Generic environmental risk assessment of clinical trials with AAV vectors

    Hundreds of clinical trials have been carried out worldwide in which use was made of ...

    Advisory reports
    CGM/190905-01 View more
  • 16-03-2018

    Generic advice on containment levels for replication-deficient adenoviral vector systems

    Vector systems based on adenoviruses are frequently used in biomedical research. In r...

    Advisory reports
    CGM/180316-01 View more
  • 04-09-2015

    Research report Assessment of preclinical gene therapy studies worldwide

    Frequently, the success of preclinical gene therapy studies in animal models is repor...

    Research reports
    CGM 2015-03 View more