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Methods Mol Biol. 2009;542:447-70. doi: 10.1007/978-1-59745-561-9_24.

Virus production for clinical gene therapy.

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1
Instituto de Biologia Experimental e Tenológica (IBET), Oeiras, Portugal.

Abstract

Gene therapy is becoming increasingly relevant for the treatment of prominent human diseases. Viral vectors are currently used in more than 50% of the gene therapy clinical trials, most of them aimed at cancer diseases. Clearly, the increasing needs of high-quality viral preparations require the elimination of process bottlenecks, streamlining the development of a viral vector into a real-world clinical tool. Virus production for clinical gene therapy can be a limiting step because many virus generation protocols rely on labor-intensive, bench-scale methods; robust, cost-effective strategies for the delivery of clinical-grade viruses are thus essential for the future of gene therapy. A comprehensive picture of key aspects on the integration of upstream and downstream processing is addressed in this chapter, by describing the case study of recombinant budded baculoviruses for gene therapy; scalable methods are described in detail as well as mandatory characterization techniques for a proper and complete quality assessment of the viral vectors.

PMID:
19565917
DOI:
10.1007/978-1-59745-561-9_24
[Indexed for MEDLINE]
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