细胞银行,先进技术(ATMP,NGS)在2023年病毒清除研讨会(VCS)上的会议,重点是通过使用快速敏感的技术实施先进的病毒检测方法来确保先进技术医药产品(ATMP)的高病毒安全性,例如下一代测序(NGS)。本次会议的所有演讲都要求用新技术取代病毒的体内测试,这些新技术已被证明在其检测能力方面具有无与伦比的广泛性,甚至可以检测未知病毒。提出了对生物制造中不定剂污染联盟(CAACB)从其成员体内和体外不定病毒测试经验以及使用NGS收集的历史数据的评估。数据令人信服地支持了用更快,更广泛的,更敏感,更准确,和更具体的病毒检测方法。此外,提出了一项由CAACB发起的合作研究,其目标是通过使用靶向NGS代替众所周知和广泛使用的中国仓鼠卵巢(CHO)细胞的体内和体外测试来重新审视传统的不定剂测试,包括使用先验知识和历史数据的计划风险评估方法。总的来说,本次会议展示了新的病毒检测方法的使用,例如NGS,代表了一个很好的机会来提供足够的病毒安全边际,具体来说,对于ATMP,下游病毒清除是不可能的。最终的ICHQ5A(R2)指南也支持该路径。
The Cell Banks, Advanced Technologies (ATMPs, NGS) session at the 2023 Viral Clearance Symposium (VCS) focused on the assurance of high virus safety profiles of advanced technology medicinal products (ATMPs) by implementation of advanced virus detection methods using rapid and sensitive technologies, such as next-generation sequencing (NGS). All presentations in this session made the need to replace in vivo testing for viruses by new technologies that have been demonstrated to be incomparably broad in their detection capabilities and can even detect unknown viruses. An evaluation of historical data collected by the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) from their members\' in vivo and in vitro adventitious virus test experience as well as on using NGS was presented. The data convincingly supported the necessity to replace in vivo testing with faster, broader, more sensitive, more accurate, and more specific virus detection methods. Additionally, a collaborative study-initiated by the CAACB-with the goal to revisit traditional adventitious agent testing by using targeted NGS to replace in vivo and in vitro tests for well-known and broadly used Chinese hamster ovary (CHO) cells was presented, including the planned risk-assessment approach using prior knowledge and historical data. Overall, this session demonstrated that the use of new virus detection methods, such as NGS, represents a great opportunity to provide sufficient viral safety margins, specifically, for ATMPs, where downstream virus clearance is not possible. This path forward is also supported by the final ICH Q5A(R2) guideline.