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Manufacturing for Commercialization
With continued clinical success and increased investment, gene therapy companies are looking toward manufacturing and commercialization of their lead therapies. The majority of gene therapies in clinical trials (92%) utilize viral vectors to carry the therapeutic gene into the target cells2. The most common method of making virus involves transfecting mammalian cells with one or more plasmid DNA to generate the viral vector. Once produced and harvested, the vector is then clarified, concentrated, purified, sterile filtered, quality tested, and stored for use either ex vivo or in vivo depending on the therapy and the virus type being used. Read More…
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