Login
欢迎浏览恩派尔生物资料网
我要投稿 请登录 免费注册 安全退出

您现在的位置是: 首页 > 实验方法 > 细胞技术

细胞技术

Release Testing of Retroviral Vectors and Gene-Modified Cells

2025-01-24 细胞技术 加入收藏
This chapter will review the design and execution of release testing requirement

This chapter will review the design and execution of release testing requirements for retroviral vectors and gene-modified cells consistent with ensuring the success of the clinical trial on the basis of current US regulatory requirements. It is the ethical and legal responsibility of the clinical trial sponsor(s) to ensure safety of the patients through proper evaluation of the drug products prior to use. Any clinical trial drug product used in human subjects must be produced and evaluated for safety, quality, purity, and effectiveness according to Current Good Manufacturing Practices appropriate for the stage of clinical development.

文章底部广告位

文章评论

加载中~