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:
- WHO annex 3 – Recommendations for the assessment of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks. See pages 101, 158-159.
- PE 5.2.3 / published in Pharmeuropa 26 – Cell substrates for the manufacture of vaccines for human use. See page 5. (password required)
- 2.6.16 PE / published in Pharmeuropa 28.2 in April 2016 – Tests for extraneous agents in viral vaccines for human use. See page 7. (password required)
- 5.2.14 PE / published in Pharmeuropa 28.2 in April 2016 – Substitution of in vivo method(s) by in vitro method(s) for the quality control of vaccines. See page 14. (password required)
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