Bioproduction Safety

References for the use of next generation sequencing in viral safety testing.


The Regulatory environment regarding the use of next generation sequencing (NGS) for biosafety” is changing rapidly. Guidelines in this area of refer to the concept of “massively parallel sequencing” or “broad molecular methods” for NGS. Discussion groups (e.g. FDA PDA) are discussing the use of NGS to replace/complement PCR and other types of in vivo testing.

The following are links to guidances which refer to the use of NGS for viral safety:


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