Summer Activity #5

Transcriptomic NGS study

Next-Generation Sequencing: transcriptomic approach study results are available

The end of the mid-year event season is the perfect time to take stock of the situation. The talks have shown global efforts to enhance biologics quality control (QC) assays.

Current adventitious virus detection methods, such as, in vivo, in vitro assays, or PCR have their limitations. Next-generation sequencing (NGS) has the potential to supplement and replace those methods. It is a powerful alternative bringing your QC program speed and most of all robustness. NGS allows for the broad detection of known, unknown, or unexpected viruses. It is an important development to avoid failure and increase patients’ outcomes. NGS has similar or greater sensitivity than PCR and in vivo assays. Additionally, it meets the 3R initiatives allowing to replace in vivo study and thus, spare the lives of thousands of living animals. (stay tuned to learn more about this specific topic in activity #7 of our summer camp).

The regulatory institutions are supporting the development and research around NGS. Specific groups are working on providing users with standardized methods and databases. The outcomes could soon be the wide implementation of this novel technology. For example, the FDA/Industry-led PDA-Advanced Virus Detection Technologies Interest Group (AVDTIG) focuses on the use of standardized NGS for adventitious virus detection in biologics. They oversee several impactful collaborative studies.

Scientists and industries are expecting huge outcomes from those works. They have a strong need to use NGS in a standardized, optimized, and validated way. Those studies’ results will be the backbone of the best practices and good applications of NGS in QC testing. One of the AVDTIG’s studies, mentioned during the last PDA Virus Forum in June 2020, is focusing on the transcriptomic approach. 10 different organizations are participating in this study comparing NGS with PCR detection. PathoQuest plays its part and we are looking forward to the results with great interest.

In the meantime, we wanted to share a study on the transcriptomic approach: “Use of a new RNA next-generation sequencing approach for the specific detection of virus infection in cells. [*]

This collaboration between the LFB, Charles River, PathoQuest, the National veterinary school of Alfort Paris, and the Institut Pasteur Paris, highlights the broader range of detection of NGS compared to PCR. It also shows how PathoQuest’s Transcriptomic approach can differentiate living viruses from carry-over.

To read it, enter our raffle to win an official printed edition of this article. The 50 first applicants will receive a hard copy at home.

[*] Brussel A, Brack B, Muth E, Zirwes R, Cheval J, Hebert C, Charpin JM, Marinaci A, Flan B, Ruppach H, Beurdeley P, Eloit M. Use of a new RNA next-generation sequencing approach for the specific detection of virus infection in cells. Biologicals. 2019 May;59:29-36. doi: 10.1016/j.biologicals.2019.03.008. Epub 2019 Apr 13.