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2016 ; 3
(ä): 16018
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Moving oncolytic viruses into the clinic: clinical-grade production,
purification, and characterization of diverse oncolytic viruses
#MMPMID27088104
Ungerechts G
; Bossow S
; Leuchs B
; Holm PS
; Rommelaere J
; Coffey M
; Coffin R
; Bell J
; Nettelbeck DM
Mol Ther Methods Clin Dev
2016[]; 3
(ä): 16018
PMID27088104
show ga
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.
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