The AAV2 reference standard was successfully filled by ATCC (2,087 vials). 23 labs are involved in the characterization testing. The QC group reviewed all submitted protocols and chose/revised a lead protocol for each assay: 1. physical particle (vector genome) titer (qPCR) 2. physical particle (capsid) titer (ELISA) 3. infectious titer by TCID50 (qPCR) and by transduction (GFP) 4. identity and protein purity (SDS-PAGE) The HeLa r/c32 cells (a rep and cap containing cell line from Philippe Moullier's laboratory) has been deposited and banked at ATCC. It is being tested and will be available in the coming weeks. The pTR-UF-11 plasmid (qPCR standard) has been deposited and banked at ATCC and is available as ATCC# MBA-331. The testing protocols are being posted to the Wil-Bio website, http://www.wilbio.com.

7-15-08 - Guidance for Industry cGMP for Phase I Investigational Drugs