Request for Proposals:

Awarded Bids:

Meeting Minutes:

Presentations:

Articles:

Container Stability Study:

This is an on-going study to look at the short-term stability (1 hour, 1 day, 3 days, 7 days) of the vector at room-temperature (the temperature for the vial filling) and long-term -80oC storage temperature (1 hour, 1 day, 14 days, 35 days, 124 days–still to be tested in October) in these containers. We have a bid proposal from Introgen Therapeutics to fill the Reference Standard in glass vials, so we conducted this comparative study since we only had stability data in polypropylene cryovials.

The vector was dispensed into both glass vials and cryovials, and stored: A) frozen; and B) room temp for the indicated time. The infectious titer (green cells) was tested at each timepoint in triplicate. (48) vials (cryo and glass) were filled with 0.5ml at 2X10e11vg/ml each (= 24ml @ 2X10e11vg/ml = 4.8x10e12vg total used), as specified for the Reference Standard.

Please see the attached stability data for the AAV2-GFP vector filled into cryovials (standard container for UF) and glass vials.

Production Schedule:

All donated reagents and materials were received, and production and purification of the reference standard started in March 2006 at the University of Florida’s Powell Gene Therapy Center Vector Core. Approximately 150ml of AAV2-GFP = 5.69X10e14vg (= 3.79X10e12vg/ml) was made.

The Reference Standard was diluted to the proper concentration (2X10e11vg/ml), filtered and divided into 2 portions. In March 2008, ATCC filled 0.5ml into each vial for a total of 2,087 vials, and the vials have been frozen and transferred to the repository at ATCC. Characterization of the Reference Standard by member laboratories will begin in Q2 of 2008, followed by statistical analysis, with availability expected in Q3, 2008.

Protocols and Test Records for AAV Reference Standards:

• Data_Report_Packet Updated 03/24/08 (Excel Form)

• Progen_AAV2_ELISA_kit_PRATV (PDF form)

• Preparation_of_Standard_for_qPCR (PDF form)

• AAV2_RSS_Stabilty_study (PDF form)

• AAV2_RSS_Infectious_titer_assays_V2 Updated 06/11/08 (PDF form)

• AAV2_RSS_Identity-Purity_assay Updated 03/24/08 (PDF form)

• AAV2_RSS_genome_copy_titration_QPCR (PDF form)

• AAV2_capsid_titer_assay_V2 Updated 06/11/08 (PDF form)

• AAV2_Reference_Standard_Handling_Instructions Added 04/16/08 (PDF form)