A basic scheme for viral safety in cell-based products

2017 Fiscal Year Final Research Report

• Project/Area Number: 26501008
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Regenerative medicine
• Research Institution: National Institute of Health Sciences
• Principal Investigator: Yusa Keisuke 国立医薬品食品衛生研究所, 再生・細胞医療製品部, 主任研究官 (30200869)
• Research Collaborator: YUAN Yuzhe 国立医薬品食品衛生研究所, 再生・細胞医療製品部
• Project Period (FY): 2014-04-01 – 2018-03-31
• Keywords: ウイルス / 再生医療 / 細胞加工製品 / 安全性 / 核酸増幅法 / 次世代シークエンサー

Outline of Final Research Achievements

Viral safety is a critical issue for cell-based products. Their starting materials (human cells or tissues in most of cases), intermediates, and final products are fragile cells or tissues, meaning that conventional treatments of virus inactivation or removal cannot be applied. NAT (nucleic acid amplification test) is a concise, quick, and highly sensitive method to detect viral nucleotides, but not suitable for comprehensive detection of viruses. Therefore an alternative virus test is needed due to the speific properties of cell-based products. To address this issue, we established a pipeline for detection of adventitious viruses in cell stock/cell bank using next generation sequencing (NGS) method. Combination of virus tests using NGS and NAT will ensure viral safety in cell-based products, although there are still several points to be improved in future.

Free Research Field

ウイルス学、ウイルス安全性