REF: Platform-based approach for AAV Gene Therapies

Platform Technology Approach for AAV & Lenti-based Gene Therapy. ASGCT Liaison Meeting with FDA (2019) (https://asgct.org/global/documents/advocacy/fda-liaison-meeting-2019/development-and-regulatory-considerations-when-lev.aspx)

Future of Drug Development, Janet Woodcock (https://www.fda.gov/media/104048/download)

Continuous Manufacturing of Drug Substances and Drug Products (https://www.fda.gov/media/165775/download) 

The Platform Vector Gene Therapies Project: Increasing the Efficiency of Adeno-Associated Virus Gene Therapy Clinical Trial Startup. Brooks et al., (2020) (https://www.liebertpub.com/doi/10.1089/hum.2020.259)