125459 May 2026

: Evaluating whether the viral vector or therapeutic gene could unintentionally be passed on to future generations.

: Characterizing potential immune responses to the viral vector or the new protein produced by the therapy. 125459

The number most commonly refers to a specific scientific guideline established by the European Medicines Agency (EMA) regarding the development of Gene Therapy Medicinal Products (GTMPs) . : Evaluating whether the viral vector or therapeutic

: Determining where the therapeutic gene goes in the body and how long it persists in both target and non-target cells. 125459