2022 Volume 4 Issue 3 Pages 61-67
In the past decade, broad virus detection methods, as represented by next-generation sequencing (NGS) technology, have gained more recognition as an effective approach to assessing the virus safety of biologics such as antibody drugs, vaccines, and gene/cell therapy products. A global group was organized as a joint effort of regulatory and industry scientists from the United States and Europe to further discuss this regulatory issue and to facilitate the implementation of NGS testing in the virus safety assessment of biologics. This global activity has proactively promoted practical studies for performance evaluations of virus detection by NGS, as well as the development of analytical tools such as reference viral reagents and a virus database. However, in Japan, it is ambiguous whether this regulatory issue concerns domestic pharmaceutical companies or the regulatory body. Therefore, we conducted a questionnaire survey to gain a picture of the Japanese pharmaceutical industry’s views regarding the utilization of NGS for virus safety assessment for biologics. The survey results indicate that most respondents have little or limited experience with NGS and a passive attitude towards NGS utilization for virus safety assessments. With the ongoing revision of the relevant guideline, ICH Q5A, concerned parties in Japanese industry and regulatory body must urgently catch up with global discussions on NGS utilization for the virus safety assessment of biologics and join the international movement.
