cell therapy group

cell therapy group, Total:94 items.

The international standard classification for "cell therapy group" includes: Biology. Botany. Zoology , Medical Sciences and health care facilities in general , Medical materials .

The Chinese standard classification for "cell therapy group" includes: Pharmaceutical in general , Sanitation in general , Medical apparatus and devices in general .

Group Standards of the People's Republic of China

T/GXDSL 005-2025 Quality Control Standards for Cold Chain Transportation of Cell Therapy Products
T/SDHCST 005-2023 Procedures for Safety Pharmacology Testing of the Cell Therapy Medical Products
T/SDHCST 003-2023 Pre-dose Quality Testing of Test Substances in Non-clinical Studies of the Cell Therapy Medical Products
T/CEAC 105-2025 TIL Cell Therapy Clinical Application Guidelines
T/SHPPA 012-2022 Validation technical requirements for rapid sterility testing method of cellular and gene therapy products
T/SDHCST 004-2023 Animal Species and Model Selection for Non-clinical Studies of the Cell Therapy Medical Products
T/CEAC 069-2024 Cell therapy Leukopak raw material collection and immune cell separation technical requirements
T/CHSA 004-2022 Expert consensus on surgical treatment of squamous cell carcinoma of tongue mucosa
T/ZGCIT 015-2024 Guidelines for Clinical Application of Mesenchymal Stem Cells from Umbilical Cord in Treatment of Knee Osteoarthritis
T/SDHCST 001-2023 General Principles on the Non-Clinical Studies of the Cell Therapy Medical Products
T/CMBA 013-2021 Specification for hospital in management of clinical application of chimeric antigen receptor T cell marketed products
T/SDHCST 006-2023 Procedures for Single Dose Toxicity Testing of the Cell Therapy Medical Products
T/FDSA 0055-2024 Guidelines for the development of Cell immunotherapy products based on mRNA-LNP technology
T/SHQAP 003-2023 Guidelines for application of space separative closed systems for cell therapies production
T/SDHCST 002-2023 Test Substance Requirements on the Non-Clinical Studies of the Cell Therapy Medical Products
T/SDHCST 007-2023 Procedures for Repeated Dose Toxicity Testing of the Cell Therapy Medical Products
T/SHSYCXH 7-2022 Test method of human monocyte populations from peripheral blood-Flow cytometry
T/SHPPA 023-2023 Long term follow-up study guidance for CAR-T cell therapy products
T/CGCPU 027-2023 Design specifications for clinical research protocol of immunotherapy
T/SBX 055-2022 Test methods for tumorigenicity of stem cell therapy products
T/SHPPA 021-2023 Import and export management guidance for CAR-T cell therapy products and their materials
T/CI 307-2024 Quality requirements of mesenchymal stem cells for therapy
T/SDHCST 008-2023 Procedures for Immunogenicity and Immunotoxicity of the Cell Therapy Medical Products
T/SHPPA 019-2023 Guidance for the manufacturing quality management of plasmids used in the production of Immune cell therapy products
T/CMBA 021-2023 Specification of quality management for ancillary materials present during the production of cellular therapeutic products
T/CEAC 109-2025 Clinical application guideline for the treatment of knee osteoarthritis and cartilage defects with mesenchymal stem cells
T/SHSYCXH 8-2022 Test method of human Natural Killer cells and Natural Killer T cells from peripheral blood-Flow cytometry
T/CAV 008-2024 Basic functional specification for cell therapy product traceability management information system

Professional Standard - Agriculture

113药典三部-2015 Monograph Ⅱ Therapeutic anti-human T cell porcine immunoglobulin
91药典三部-2010 Chapter Ⅱ Therapeutic anti-human T cell porcine immunoglobulin
152药典三部-2020 Monograph Ⅱ Therapeutic topical bovine basic fibroblast growth factor
146药典三部-2015 Monograph II Therapeutic Recombinant Bovine Basic Fibroblast Growth Factor Eye Drops
124药典三部-2020 Monograph Ⅱ Therapeutic anti-human T cell porcine immunoglobulin
121药典三部-2010 Chapter II Therapeutic Recombinant Bovine Basic Fibroblast Growth Factor Gel
153药典三部-2020 Monograph II Therapeutic Bovine Basic Fibroblast Growth Factor Gel
125药典三部-2020 Monograph Ⅱ Therapeutic Anti-human T-cell Rabbit Immunoglobulins
143药典三部-2015 Monograph II Therapeutic Recombinant Bovine Basic Fibroblast Growth Factor Solution for External Use
141药典三部-2015 Monograph II Therapeutic Recombinant Human Granulocyte Stimulating Factor Injection
149药典三部-2020 Monograph II Therapeutic Human Granulocyte Macrophage Stimulating Factor for Injection
142药典三部-2015 Monograph II Therapeutic Recombinant Human Granulocyte Macrophage Stimulating Factor for Injection
154药典三部-2020 Monograph Ⅱ Therapeutic Bovine Basic Fibroblast Growth Factor Eye Drops
115药典三部-2015 Monograph II Therapeutic Recombinant Human Erythropoin for Injection (CHO Cell)
145药典三部-2015 Monograph II Therapeutic Recombinant Bovine Basic Fibroblast Growth Factor Gel
116药典三部-2015 Monograph II Therapeutic Recombinant Human Erythropoin Injection (CHO Cell)
151药典三部-2020 Monograph Ⅱ Therapeutic bovine basic fibroblast growth factor solution for external use
126药典三部-2010 Chapter Ⅱ Therapeutic class Anti-human T cell CD3 mouse monoclonal antibody for injection
92药典三部-2010 Chapter Ⅱ Therapeutic Anti-human T-cell Rabbit Immunoglobulin
118药典三部-2010 Chapter II Therapeutic Recombinant Human Granulocyte Macrophage Stimulating Factor for Injection
120药典三部-2010 Chapter II Therapeutic Recombinant Bovine Basic Fibroblast Growth Factor for External Use
117药典三部-2010 Chapter II Therapeutic Recombinant Human Granulocyte Stimulating Factor Injection
1021药典化学药和生物制品卷-2010 Chapter 12 Antineoplastic Drugs Section 3 Biological Targeted Therapy Drugs Recombinant Human Granulocyte Macrophage Stimulating Factor
93药典三部-2010 Chapter II Therapeutic Recombinant Human Erythropoin for Injection (CHO Cell)
148药典三部-2020 Monograph Ⅱ Therapeutic human granulocyte-stimulating factor injection
114药典三部-2015 Monograph Ⅱ Therapeutic Anti-human T-cell Rabbit Immunoglobulins
94药典三部-2010 Chapter II Therapeutic Recombinant Human Erythropoin Injection (CHO Cell)
144药典三部-2015 Monograph Ⅱ Therapeutic topical recombinant bovine basic fibroblast growth factor
150药典三部-2020 Monograph Ⅱ Therapeutic topical human granulocyte macrophage stimulating factor gel

Shanghai Provincial Standard of the People's Republic of China

DB31/T 687-2013 Basic requirements for clinical cell therapy platform settings

Hebei Provincial Standard of the People's Republic of China

DB13/T 5332-2021 Technical specification for clinical operation of cellular immunotherapy

未注明发布机构

CLSI H42-A2-2007 Flow cytometric enumeration of immune-defined cell populations

Professional Standard - Hygiene

WS/T 360-2011 Guidelines for peripheral lymphocyte subsets by flow cytometry
WS/T 360-2024 Guideline for enumeration of peripheral blood lymphocyte subsets by flow cytometry

National Health Commission of the People's Republic of China

WST 360:2011 Guidelines for detection of peripheral blood lymphocyte subsets by flow cytometry

Professional Standard - Medicine

YY/T 1465.6-2019 Immunogenic evaluation method of medical devices―Part 6:Determination of animal spleen lymphocyte subsets by flow cytometry

Gansu Provincial Standard of the People's Republic of China

DB62/T 2688-2016 Technical specification for the prevention and treatment of sheep eperythrozoonosis

American Society for Testing and Materials (ASTM)

ASTM F3368-19 Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products
ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
ASTM F3209-24 Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy

Korean Agency for Technology and Standards (KATS)

KS P 1600-2018(2023) General guideline of safety test for the cell based therapeutic substances
KS P 1600-2023 General guideline of safety test for the cell based therapeutic substances
KS J ISO 21973-2023 Biotechnology — General requirements for transportation of cells for therapeutic use
KS P 1600-2007 General guideline of safety test for the cell based therapeutic substances
KS J ISO 20399-2025 Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products

Bureau of Indian Standards

IS 17711-2021 Biotechnology General requirements for transportation of cells for therapeutic use
IS 18609-2024 Biotechnology-Ancillary Materials Present During the Production of Cellular Therapeutic Products and Gene Therapy Products
IS/ISO 20404-2023 Biotechnology-Bioprocessing-General Requirements for the Design of Packaging to Contain Cells for Therapeutic Use

IT-UNI

UNI ISO 21973:2021 Biotechnology - General requirements for transportation of cells for therapeutic use

International Organization for Standardization (ISO)

ISO 21973:2020 Biotechnology — General requirements for transportation of cells for therapeutic use
ISO 20399:2022 Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products
ISO 20404:2023 Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use

Danish Standards Foundation

DANSK DS/ISO 21973:2020 Biotechnology – General requirements for transportation of cells for therapeutic use
DANSK DS/ISO 20399:2022 Biotechnology – Ancillary materials present during the production of cellular therapeutic products and gene therapy products
DANSK DS/ISO 20404:2023 Biotechnology – Bioprocessing – General requirements for the design of packaging to contain cells for therapeutic use

Gosstandart of Russia

GOST R ISO 21973-2023 Biotechnology. General requirements for transportation of cells for therapeutic use

British Standards Institution (BSI)

BS ISO 21973:2020 Biotechnology. General requirements for transportation of cells for therapeutic use
BS PAS 83:2006 Guidance on codes of practice, standardised methods and regulations for cell-based therapeutics
BS ISO 20399:2022 Biotechnology. Ancillary materials present during the production of cellular therapeutic products and gene therapy products
19/30354962 DC BS ISO 21973. Biotechnology. General requirements for transportation of cells for therapeutic use
22/30424231 DC BS ISO 20399. Biotechnology. Ancillary materials present during the production of cellular therapeutic products and gene therapy products
BS ISO 20404:2023 Biotechnology. Bioprocessing. General requirements for the design of packaging to contain cells for therapeutic use
22/30428167 DC BS ISO 20404. Biotechnology. Bioprocessing. General requirements for the design of packaging to contain cells for therapeutic use

GCC Standardization Organization

GSO ASTM F3206:2022 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ASTM F3206:2023 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies

Ente Nazionale Italiano di Unificazione

UNI ISO 20404:2024 Biotechnology - Bioprocessing - General requirements for the design of packaging to contain cells for therapeutic use