Application Note

Accelerating Bulk Harvest Release Testing Using The Rapid Adventitious Virus Detection Blazar® CHO Animal Origin Free Virus Panel

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Adventitious agent testing is frequently a bottleneck in downstream processing. Typically, the bulk harvest stage relies on time-intensive culture-based methods that amplify the contaminating agent. To shorten turnaround time and meet the growing demand for faster manufacturing, alternative methods are necessary.

This industry need can be fulfilled by molecular methods. Regulatory guidelines like the ICH Q5A document support the use of nucleic acid-based technologies for virus detection. Although next-generation sequencing technologies utilize a sequence-agnostic approach to detect viral sequences, they often do not provide the speed necessary for a rapid bulk harvest lot release. On the other hand, standard PCR-based methods are faster, typically taking only days, but they usually only target a single virus.

For manufacturing processes using CHO cells and animal origin-free components, the Rapid Adventitious Virus detection: Blazar® CHO AOF panel provides an optimal blend of speed, sensitivity, and broad detection capability, serving as a viable alternative to the in vitro virus assay. Continue reading to learn more about this panel that employs degenerate PCR methodology to achieve broad-spectrum virus detection in under two weeks.

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