How to Replace Legacy Testing Methods with NGS

Biologics are life-changing but vulnerable products. Viral contamination incidents, while rare, can threaten patient safety, disrupt production, and damage reputations. Traditional virus detection methods like in vivo adventitious virus tests, antibody production tests (MAP/HAP/RAP), cell-based assays, and PCR-based methods have served the industry for decades but increasing product complexity and faster drug product supply demand more efficient and advanced technologies for viral contaminant detection.

Next Generation Sequencing (NGS) has emerged as a transformative technology, enabling fast, agnostic, broad, and highly sensitive virus detection and identification. The 2023 revision of ICH Q5A and new guidance from regulatory authorities now explicitly support the integration of NGS into viral safety programs and support the path to faster, safer, and more ethical biologics manufacturing. In short, NGS future-proofs your viral safety strategy.

This whitepaper explores the limitations of legacy methods and how validated NGS technology lets biotechs streamline viral safety testing, reduce risk, accelerate market access, and lay the foundation for success.

Authors

  • Horst Ruppach, Executive Director Scientific and Portfolio GLBL Biologics, Charles River
  • Olaf Stamm, Technical Business Development Director, Charles River
  • Kerstin Brack, Scientific Director GLBL Biosafety, Charles River