Next Generation Sequencing (NGS) For Adventitious Agent Detection In Cell Banks

The use of Next Generation Sequencing (NGS) in the biosafety testing space has grown dramatically over the past decade with the advent of advanced instrumentation. Once considered to be cutting-edge methods limited to only research and development, instrumentation and systems have been refined in such a way that lends themselves to compliant regulated testing.

Adventitious agent testing (AAT) using NGS has similar characteristics to traditional test methods in that it is a broad screening assay that can detect both expected and unexpected viruses. Moreover, NGS is an unbiased method since detection of a viral contaminant is not dependent upon replication within a host as is the case with traditional methods. Furthermore, NGS not only detects the presence of viruses but can also be used to identify contaminants without the need for additional methods.

The use of NGS to demonstrate the safety of biological products is part of a comprehensive biosafety testing strategy. Regulatory authorities are receptive to the use of novel technologies as alternatives to established virus detection methods, as long as the alternative testing strategies are properly validated, shown to be fit for purpose for the sample being tested, and are comparable or better than existing assays. The ability of NGS-based methods for agnostic broad-range detection makes it a suitable option to augment or replace current virus testing methodology.

Explore a NGS AAT method for cell line characterization, representative results from a HEK293 master cell bank, and more.