Tài liệu kĩ thuật làm căn cứ xây dựng Dự thảo TCVN về Tế bào trị liệu

Quý vị vui lòng chỉ sử dụng các tài liệu dưới đây cho mục đích góp ý Dự thảo TCVN về Tế bào trị liệu.

ISO 21973:2020

Biotechnology — General requirements for transportation of cells for therapeutic use

ISO 20404:2023

Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use

ISO 20399:2022

Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products

ISO 23033:2021

Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products

ISO/TS 23565:2021

Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use

ISO/TS 22859:2022

Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from umbilical cord tissue

ISO 24651:2022

Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow

ISO 24603:2022

Biotechnology — Biobanking — Requirements for human and mouse pluripotent stem cells