Newer guidelines and recommendations increasing identify high throughput sequencing (HTS) as a highly sensitive alternative or adjunct to less sensitive testing methods currently being utilized. The following are links to guidances which refer to the use of NGS for biologics safety testing:

  • European Pharmacopeia (published January 2018)

2.6.16    Test for extraneous agents in viral vaccines for human use
5.2.3      Cell substrates for the production of vaccines for human use 
5.12.4    Substitution of in vivo method(s) by in vitro method(s) for the quality control of vaccines 
5.14       Gene transfer medicinal products for human use 

  • International Conference On Harmonisation (ICH) Q5B – Quality of Biotechnological Products: Analysis of the Expression Construct in Cells used for Production of r-Dna Derived Protein Products

The nucleotide sequence of the coding region of the gene of interest and associated flanking regions that are inserted into the vector, up to and including the junctions of insertion, should be determined by DNA sequencing of the construct.

  • European Medicines Agency (EMA) – CHMP/GTWP/671639/2008 Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
  • U.S. Food and Drug Administration (FDA)

FDA, Parenteral Drug Association (PDA) and Advanced Virus Detection Technologies Interest Group (AVDTIG): a joint effort designed to facilitate discussions and provide a forum for sharing data and experiences using advanced new virus detection technologies with a focus on high-throughput sequencing technology (link)

FDA Guidance for Human Somatic Cell Therapy and Gene Therapy

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