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Advisory reports 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 recent years increasingly advanced vector systems have been developed based on these viruses and scientific understanding of and experience with the use of these systems is increasing. To streamline the authorisation procedure for these systems, COGEM commissioned a study to determine whether or not activities involving these vector systems are eligible for a generic downgrading of containment level.

Based on the resulting report, COGEM distinguishes between three adenoviral vector systems. For each of these systems, COGEM recommends appropriate containment levels for the production of the vectors and activities involving them. Regarding activities, COGEM makes a further distinction between laboratory experiments and experiments on test animals.