Adeno-Associated Viral Vectors for Gene Therapy by T.R. Flotte, and K.I. Berns (Eds.)

By T.R. Flotte, and K.I. Berns (Eds.)

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7, 1145–1159. Gao, G. P. et al. (1998). High‐titer adeno‐associated viral vectors from a Rep/ Cap cell line and hybrid shuttle virus [In Process Citation]. Hum. Gene Ther. 9, 2353–2362. Gao, G. P. et al. (2002). Novel adeno‐associated viruses from rhesus monkeys as vectors for human gene therapy. Proc. Natl. Acad. Sci. USA 99, 11854–11859. Gao, G. et al. (2003). Adeno‐associated viruses undergo substantial evolution in primates during natural infections. Proc. Natl. Acad. Sci. USA 100, 6081–6086.

Academic researchers may find it diYcult to establish testing facilities compliant with GLPs within their own institutions. Crucial to compliance is the formation of a Quality Assurance Unit (QAU) separate from and independent of the personnel engaged in the direction and/or conduct of the safety study. The QAU is responsible for monitoring the study to assure that the study is performed in compliance with GLPs. The researcher may turn to a National Gene Vector Laboratory or commercial GLP testing facilities for performance of safety testing.

The method, however, provides no information as to the functional status of the expression cassette delivered by the viral particle. , 1996) are infected with serial dilutions of rAAV and superinfected with adenovirus at a MOI of 5–20 for 40 h. Cells that have been infected by rAAV are then complemented for DNA replication and amplify the rAAV genome to several thousand copies per cell. When the cells are subsequently trapped on nylon filters, lysed by treatment with NaOH, and probed for transgene DNA, only those cells that have been productively infected with rAAV produce a spot on film (Fig.

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