Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
European Directorate for the Quality of Medicines and Healthcare, Strasbourg, France.
Biologicals. 2023 Aug;83:101696. doi: 10.1016/j.biologicals.2023.101696. Epub 2023 Jul 19.
Next-generation sequencing (NGS) has been proven to address some of the limitations of the current testing methods for adventitious virus detection in biologics. The International Alliance for Biological Standardization (IABS), the U.S. Food and Drug Administration (FDA), and the European Directorate for the Quality of Medicines and Healthcare (EDQM) co-organized the "3rd Conference on Next-generation Sequencing for Adventitious Virus Detection in Biologics for Humans and Animals", which was held on September 27-28, 2022, in Rockville, Maryland, U.S.A. The meeting gathered international representatives from regulatory and public health authorities and other government agencies, industry, contract research organizations, and academia to present the current status of NGS applications and the progress on NGS standardization and validation for detection of viral adventitious agents in biologics, including human and animal vaccines, gene therapies, and biotherapeutics. Current regulatory expectations were discussed for developing a scientific consensus regarding using NGS for detection of adventitious viruses. Although there are ongoing improvements in the NGS workflow, the development of reference materials for facilitating method qualification and validation support the current use of NGS for adventitious virus detection.
下一代测序(NGS)已被证明可以解决当前生物制品中偶然病毒检测方法的一些局限性。国际生物标准化联盟(IABS)、美国食品和药物管理局(FDA)和欧洲药品质量管理局(EDQM)共同组织了“第三届人类和动物用生物制品中偶然病毒检测的下一代测序会议”,该会议于 2022 年 9 月 27 日至 28 日在美国马里兰州罗克维尔举行。会议聚集了来自监管和公共卫生当局以及其他政府机构、行业、合同研究组织和学术界的国际代表,介绍了 NGS 应用的现状以及 NGS 标准化和验证的进展,用于检测生物制品中的病毒外来剂,包括人类和动物疫苗、基因治疗和生物治疗药物。讨论了制定使用 NGS 检测偶然病毒的科学共识的当前监管期望。尽管 NGS 工作流程正在不断改进,但参考材料的开发有助于方法资格和验证,支持当前 NGS 用于偶然病毒检测。