Article | October 24, 2017

Utility Of Next-Generation Sequencing (NGS) For Biosafety Assessment Of Biological Products

By Colette Côté Ph.D., Lakshmi Viswanathan, Sindy John, and Audrey Chang, Ph.D.

Utility Of GMP Next-Generation Sequencing (NGS) For Biosafety Assessment Of Biological Products

The advent of next-generation sequencing (NGS), also referred to as massively parallel or deep sequencing, affords a radically different approach to the challenge of identifying and characterizing known and unknown agents (sequences) with precision and sensitivity. By delivering significantly more data than traditional Sanger-based sequencing methods, NGS opens a range of possibilities for the analysis of diverse DNA and RNA populations.

NGS does not require any prior knowledge of the sample sequence; the technology is capable of detecting all sequences in a sample, whether known or not. An NGS library is constructed from sample nucleic acid and then sequenced. Comparison of a sequence to target sequences or to libraries of known reference sequences using bioinformatics programs reveals identities. Identification of novel sequences is made possible by virtue of homology to known elements/sequences.

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