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Next Generation Sequencing (NGS) Internal Controls for Adventitious Agent Testing to Ensure Sensitivity for All Targets in Every Sample

Our proposal will develop a test kit—AccuKit— that streamline adventitious agent screening while directly ensuring every target is measured with the required sensitivity.
Categories
Drug substance
Drug product
Assays
Project status
100% Completed

Industry Need

  • Adventitious agent testing of Master and Working cell banks is one critical aspect of purity testing as it minimizes risk of upstream contamination. 
  • Adventitious agent testing is moving away from the use of animal models to more in vitro tests such as cell culture and PCR-based methods.


Solution

AccuGenomics and NC State will develop a test kit (“AccuKit”) that will streamline adventitious agent screening while directly ensuring every target is measured with the required sensitivity

  • AccuKits will incorporate PCR primers specific for 22 known adventitious viruses and bacteria for high throughput NGS screening assays.  
  • The kit will contain a mixture of competitive templates for every adventitious agent spiked into every sample as internal sensitivity controls; the expected test result for contamination should be positive for every spike-in target and negative for the native targets.  
  • The platform allows for additional primer sets to be added to the AccuKit to meet future adventitious agent detection needs. The team intends to advance its MRL-4 level technology to MRL-6.


Updates, Related Publications, and Deliverables

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Project Lead

Accugenomics Inc

Accugenomics Inc

Participating Organizations

North Carolina State University

North Carolina State University