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lüll Large-scale adeno-associated viral vector production using a herpesvirus-based system enables manufacturing for clinical studies Clement N; Knop DR; Byrne BJHum Gene Ther 2009[Aug]; 20 (8): 796-806The ability of recombinant adeno-associated viral (rAAV) vectors to exhibit minimal immunogenicity and little to no toxicity or inflammation while eliciting robust, multiyear gene expression in vivo are only a few of the salient features that make them ideally suited for many gene therapy applications. A major hurdle for the use of rAAV in sizeable research and clinical applications is the lack of efficient and versatile large-scale production systems. Continued progression toward flexible, scalable production techniques is a prerequisite to support human clinical evaluation of these novel biotherapeutics. This review examines the current state of large-scale production methods that employ the herpes simplex virus type 1 (HSV) platform to produce rAAV vectors for gene delivery. Improvements have substantially advanced the HSV/AAV hybrid method for large-scale rAAV manufacture, facilitating the generation of highly potent, clinical-grade purity rAAV vector stocks. At least one human clinical trial employing rAAV generated via rHSV helper-assisted replication is poised to commence, highlighting the advances and relevance of this production method.|*Clinical Trials as Topic[MESH]|Dependovirus/classification/*genetics/*growth & development[MESH]|Gene Transfer Techniques[MESH]|Genetic Vectors/*biosynthesis[MESH]|Herpesviridae/*genetics[MESH]|Humans[MESH]|Serotyping[MESH] |