Guidance Update: Determination of Genomic Titre and Vector Copy Number for rAAV and LV/RV Products

The British Pharmacopoeia has published the first update to the Determination of Genomic Titre and Vector Copy Number for rAAV and LV/RV Products guidance document.

This update includes a revision of the main guidance and introduces new annexes containing validation protocols and example reports for Polymerase Chain Reaction (PCR)-based assays. The validation plan outlines the key steps required to establish and verify the performance of quantitative PCR (qPCR) and digital PCR (dPCR) methods. These annexes include detailed protocols and illustrative reports for two primary applications: determination of Adeno-associated virus (AAV) genomic titre and Lentiviral vector (LV) copy number.

Download your copy here or browse the guidance by using the BP.