Scientific Publications by FDA Staff

PDA J Pharm Sci Technol 2016 Nov-Dec;70(6):591-5

Advanced Virus Detection Technologies Interest Group (AVDTIG): efforts for high throughput sequencing (HTS) for virus detection.

Khan AS, Vacante DA, Cassart JP, Ng SH, Lambert C, Charlebois RL, King K

Several nucleic-acid based technologies have recently emerged with capabilities for broad virus detection. One of these, high throughput sequencing (HTS), has the potential for novel virus detection since this method does not depend upon prior viral sequence knowledge. However, the use of HTS for testing biologicals poses greater challenges as compared to other newly-introduced tests due to its technical complexities and big data bioinformatics. Thus, an Advanced Virus Detection Technologies Users Group was formed as a joint effort by regulatory and industry scientists to facilitate discussions and provide a forum for sharing data and experiences using advanced new virus detection technologies with a focus on HTS technologies. The group was initiated as a Task Force that was coordinated by the Parenteral Drug Association (PDA) and subsequently became a PDA Interest Group (AVDTIG) to continue efforts for using new technologies for detection of adventitious viruses with broader participation, including international government agencies, academia, and technology service providers.