Guidelines

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PathoQuest is proud to have several company affiliated individuals participating as members of the Advanced Virus Detection Technologies User Group (AVDTIG), a task force coordinated by the Parenteral Drug Association (PDA) which is composed of representatives from the U.S. Food and Drug Association (FDA) and industry (link). This task force was created by the PDA/FDA to provide a forum for discussions and scientific collaborations related to the identification and advancement of newer tools and technologies for virus risk detection and the characterization of biological materials used in the production of vaccines and recombinant therapeutic products. PathoQuest has been a participant of AVDTIG since 2014 and was selected to be an integral member of the group as a result of the company’s recognized leadership, experience and expertise related to the application of next-generation sequencing (NGS) in this field.

Click on the links below to view two new publications from AVDTIG participants:

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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

Click here to learn more about PathoQuest’s Biologics Genomic Service for biopharmaceutical companies.