Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Paul-Ehrlich-Institut, Langen, Germany.
Biologicals. 2020 Sep;67:94-111. doi: 10.1016/j.biologicals.2020.06.002. Epub 2020 Jul 11.
The IABS-EU, in association with PROVAXS and Ghent University, hosted the "2 Conference on Next Generation Sequencing (NGS) for Adventitious Virus Detection in Human and Veterinary Biologics" held on November 13 and 14 2019, in Ghent, Belgium. The meeting brought together international experts from regulatory agencies, the biotherapeutics and biologics industries, contract research organizations, and academia, with the goal to develop a scientific consensus on the readiness of NGS for detecting adventitious viruses, and on the use of this technology to supplement or replace/substitute the currently used assays. Participants discussed the progress on the standardization and validation of the technical and bioinformatics steps in NGS for characterization and safety evaluation of biologics, including human and animal vaccines. It was concluded that NGS can be used for the detection of a broad range of viruses, including novel viruses, and therefore can complement, supplement or even replace some of the conventional adventitious virus detection assays. Furthermore, the development of reference viral standards, complete and correctly annotated viral databases, and protocols for the validation and follow-up investigations of NGS signals is necessary to enable broader use of NGS. An international collaborative effort, involving regulatory authorities, industry, academia, and other stakeholders is ongoing toward this goal.
IABS-EU 与 PROVAXS 和根特大学合作，于 2019 年 11 月 13 日至 14 日在比利时根特举办了“第二届下一代测序（NGS）在人用和兽用生物制品中检测外来病毒会议”。会议聚集了来自监管机构、生物治疗和生物制品行业、合同研究组织和学术界的国际专家，旨在就 NGS 检测外来病毒的准备情况以及该技术用于补充或替代当前使用的检测方法达成科学共识。与会者讨论了 NGS 在生物制品（包括人用和动物疫苗）的特性和安全性评估方面的标准化和验证的技术和生物信息学步骤的进展。会议得出的结论是，NGS 可用于检测广泛的病毒，包括新型病毒，因此可以补充、补充甚至替代一些常规的外来病毒检测方法。此外，有必要开发参考病毒标准、完整且正确注释的病毒数据库以及用于 NGS 信号验证和后续调查的方案，以便更广泛地使用 NGS。为了实现这一目标，正在进行涉及监管机构、行业、学术界和其他利益相关者的国际合作努力。
