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@ARTICLE{Ungerechts:130700,
      author       = {G. Ungerechts$^*$ and S. Bossow and B. Leuchs$^*$ and P. S.
                      Holm and J. Rommelaere$^*$ and M. Coffey and R. Coffin and
                      J. Bell and D. Nettelbeck$^*$},
      title        = {{M}oving oncolytic viruses into the clinic: clinical-grade
                      production, purification, and characterization of diverse
                      oncolytic viruses.},
      journal      = {Molecular therapy},
      volume       = {3},
      issn         = {2329-0501},
      address      = {New York, NY},
      publisher    = {Nature Publishing Group},
      reportid     = {DKFZ-2017-05778},
      pages        = {16018 -},
      year         = {2016},
      abstract     = {Oncolytic viruses (OVs) are unique anticancer agents based
                      on their pleotropic modes of action, which include, besides
                      viral tumor cell lysis, activation of antitumor immunity. A
                      panel of diverse viruses, often genetically engineered, has
                      advanced to clinical investigation, including phase 3
                      studies. This diversity of virotherapeutics not only offers
                      interesting opportunities for the implementation of
                      different therapeutic regimens but also poses challenges for
                      clinical translation. Thus, manufacturing processes and
                      regulatory approval paths need to be established for each OV
                      individually. This review provides an overview of
                      clinical-grade manufacturing procedures for OVs using six
                      virus families as examples, and key challenges are discussed
                      individually. For example, different virus features with
                      respect to particle size, presence/absence of an envelope,
                      and host species imply specific requirements for measures to
                      ensure sterility, for handling, and for determination of
                      appropriate animal models for toxicity testing,
                      respectively. On the other hand, optimization of serum-free
                      culture conditions, increasing virus yields, development of
                      scalable purification strategies, and formulations
                      guaranteeing long-term stability are challenges common to
                      several if not all OVs. In light of the recent marketing
                      approval of the first OV in the Western world, strategies
                      for further upscaling OV manufacturing and optimizing
                      product characterization will receive increasing attention.},
      cin          = {G100 / F010 / F110},
      ddc          = {610},
      cid          = {I:(DE-He78)G100-20160331 / I:(DE-He78)F010-20160331 /
                      I:(DE-He78)F110-20160331},
      pnm          = {316 - Infections and cancer (POF3-316)},
      pid          = {G:(DE-HGF)POF3-316},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:27088104},
      pmc          = {pmc:PMC4822647},
      doi          = {10.1038/mtm.2016.18},
      url          = {https://inrepo02.dkfz.de/record/130700},
}