Large-scale downstream processing of viruses for clinical applications poses challenges which differ from those of many other biotherapeutics. These challenges arise, in part, from viral size and complexity. For example, the adenovirus vector, which comprises 25% of all gene therapy clinical trials due to its ability to infect both nondividing and dividing cells with persistent expression, contains over 2700 protein subunits with a mass of approximately 165 MDa and a diameter of about 0.1 µm. Further complexity is attributed to the tendency of adenovirus particles to be acid labile.<br/><br/>Here, we present purification results of a cGMP-like process developed for a recombinant adenovirus. The two-step column process results in an adenovirus preparation with high yield and very low host cell protein and DNA contamination comparable to clinical grade products.

Development of a cGMP-compatible purification process for adenovirus purification

251st National Meeting (2016)

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