Identification of infectious viruses for risk‐based virus testing of CHO unprocessed bulk using next‐generation sequencing
Tiffany Hsu,
Mary Jo Talley,
Ping Yang
et al.
Abstract:It is important to increase manufacturing speed to make medicines more widely available. One bottleneck for CHO‐based drug substance release is the in vitro viral (IVV) cell‐based assay on unprocessed bulk. To increase process speed, we evaluate the suitability of replacing the IVV cell‐based assay with next‐generation sequencing (NGS). First, we outline how NGS is currently used in the pharmaceutical industry, and how it may apply to CHO virus testing. Second, we examine CHO virus contamination history. Since… Show more
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