Outstanding Issues A Largescale Production

For those skilled in the art, the Cre/loxP system has been adequate for producing modest amounts of vector suitable for small animal experiments and limited low-dose large animal studies. However, the system's complexity, requiring a helper virus and multiple serial coinfections, renders large-scale vec tor production time consuming, laborious, and costly, especially for those with little practical experience with Ads. Although technical in nature, this difficulty is arguably the most significant obstacle currently hindering the progress of this promising gene therapy technology. Large quantities of vector will certainly be required for meaningful safety and efficacy studies of high-dose administration in large animal models and for clinical applications. Clearly, development of improved methods for large-scale vector production will be needed if this technology is to progress beyond the laboratory and into the clinic.

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