NGS-Based Viral Safety Testing for ATMPs: Mandatory or Just an Option?

By Horst Ruppach
Volume 23, Open Access (April 2024)

The heterogenous group of advanced therapy medicinal products (ATMPs) are biologics with frequently limited viral safety profiles. As compared to well-established biologics such as monoclonal antibody products, the risk of virus contamination is significantly higher for some ATMPs. The standard approaches and tools used to mitigate the viral risk have limitations, leaving open the chances of missing virus contamination in an ATMP manufacturing process in both upstream and downstream. Next-generation sequencing (NGS) technology can overcome the residual risk by having the potential to detect any kind of virus contamination based on its inherent capability to detect any kind of nucleic acid in a sample. It perfectly combines the benefits and compensates for the downsides of the existing testing tools. It will replace a bunch of different established testing methods at improved turnaround times and, in the end, reduced overall costs. The combination of these characteristics is making NGS-based virus testing an in-demand and preferred approach to mitigating the virus contamination risk across all kinds of biologics mid- and long-term.

Citation:
Ruppach H. NGS-based viral safety testing for ATMPs: mandatory or just an option? BioProcess J, 2024; 23. https://doi.org/10.12665/J23OA.Ruppach

Posted online April 27, 2024.