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Manufacturing of viral vectors: part II. Downstream processing and safety aspects

Otto-Wilhelm Merten, Matthias Schweizer, Parminder Chahal and Amine Kamen

Manufacturing of viral vectors comprises the generation of these vectors, which then have to be purified in order to meet the quality attributes required for further use as gene delivery systems. The first part of this article deals with the production of the most important viral vectors used in gene therapy protocols. In the second part, we briefly review the most current methods used for the purification of viral gene therapy products focusing on four viral vectors that have been the most extensively used in clinical trials: adenoviral, adeno-associated viral and lentiviral vectors. Traditionally, γ-retroviral vectors were not purified and clarified vectors containing culture supernatant was directly used for ex vivo gene therapy. The final section of this article reviews some of the basic biosafety considerations specific to the respective viral vectors.