Review
Open access
Sep 2026
Immunogenicity in Approved Adeno-Associated Virus-Based Gene Therapies: A Framework for a Tailored Assessment Strategy
A comprehensive review of the nonclinical and clinical immunogenicity data from nine AAV-based GTPs approved by the US Food and Drug Administration and European Medicines Agency between 2017 and early 2026 offers science-based recommendations to inform the future development of GTPs.
Ching-Ha Lai, Susan C. Irvin, L. Salazar-Fontana et al.
· AAPS Journal · 0 citations