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000130700 0247_ $$2doi$$a10.1038/mtm.2016.18
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000130700 1001_ $$0P:(DE-He78)833f90e2abdd29594ad5c4f08600f191$$aUngerechts, Guy$$b0$$eFirst author$$udkfz
000130700 245__ $$aMoving oncolytic viruses into the clinic: clinical-grade production, purification, and characterization of diverse oncolytic viruses.
000130700 260__ $$aNew York, NY$$bNature Publishing Group$$c2016
000130700 3367_ $$2DRIVER$$aarticle
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000130700 520__ $$aOncolytic 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.
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000130700 7001_ $$aBossow, Sascha$$b1
000130700 7001_ $$0P:(DE-He78)119d7d540a0e6fc5734898bef4866d7f$$aLeuchs, Barbara$$b2$$udkfz
000130700 7001_ $$aHolm, Per S$$b3
000130700 7001_ $$0P:(DE-He78)2d7958ea507b0b738619074b38ec6d54$$aRommelaere, Jean$$b4$$udkfz
000130700 7001_ $$aCoffey, Matt$$b5
000130700 7001_ $$aCoffin, Rob$$b6
000130700 7001_ $$aBell, John$$b7
000130700 7001_ $$0P:(DE-He78)a074bc4fb40eed64043b5d34b4d6d523$$aNettelbeck, Dirk$$b8$$eLast author$$udkfz
000130700 773__ $$0PERI:(DE-600)2863173-0$$a10.1038/mtm.2016.18$$gVol. 3, p. 16018 -$$p16018 -$$tMolecular therapy$$v3$$x2329-0501$$y2016
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000130700 9201_ $$0I:(DE-He78)G100-20160331$$kG100$$lTranslationale Onkologie$$x0
000130700 9201_ $$0I:(DE-He78)F010-20160331$$kF010$$lTumorvirologie$$x1
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