Boost Cell Therapy
Boost Cell Therapy, Total:101 items.
The international standard classification for "Boost Cell Therapy" includes: Biology. Botany. Zoology .
The Chinese standard classification for "Boost Cell Therapy" includes: Pharmaceutical in general .
Group Standards of the People's Republic of China
- T/CEAC 109-2025 Clinical application guideline for the treatment of knee osteoarthritis and cartilage defects with mesenchymal stem cells
- T/CEAC 069-2024 Cell therapy Leukopak raw material collection and immune cell separation technical requirements
- T/SDHCST 001-2023 General Principles on the Non-Clinical Studies of the Cell Therapy Medical Products
- 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/SHPPA 021-2023 Import and export management guidance for CAR-T cell therapy products and their materials
- T/CEAC 105-2025 TIL Cell Therapy Clinical Application Guidelines
- T/SDHCST 005-2023 Procedures for Safety Pharmacology Testing of the Cell Therapy Medical Products
- T/GXDSL 005-2025 Quality Control Standards for Cold Chain Transportation of Cell Therapy Products
- T/FDSA 0055-2024 Guidelines for the development of Cell immunotherapy products based on mRNA-LNP technology
- T/CMBA 021-2023 Specification of quality management for ancillary materials present during the production of cellular therapeutic products
- T/SDHCST 006-2023 Procedures for Single Dose Toxicity Testing 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 013-2021 Specification for hospital in management of clinical application of chimeric antigen receptor T cell marketed products
- T/SBX 055-2022 Test methods for tumorigenicity of stem cell therapy products
- T/CAV 008-2024 Basic functional specification for cell therapy product traceability management information system
- T/CHSA 004-2022 Expert consensus on surgical treatment of squamous cell carcinoma of tongue mucosa
- T/SDHCST 008-2023 Procedures for Immunogenicity and Immunotoxicity of the Cell Therapy Medical Products
- T/CI 307-2024 Quality requirements of mesenchymal stem cells for therapy
- T/SDHCST 003-2023 Pre-dose Quality Testing of Test Substances in Non-clinical Studies of the Cell Therapy Medical Products
- T/ZGCIT 015-2024 Guidelines for Clinical Application of Mesenchymal Stem Cells from Umbilical Cord in Treatment of Knee Osteoarthritis
- 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/SHQAP 003-2023 Guidelines for application of space separative closed systems for cell therapies production
- T/CGCPU 027-2023 Design specifications for clinical research protocol of immunotherapy
Professional Standard - Agriculture
- 149药典 三部-2020 Monograph II Therapeutic Human Granulocyte Macrophage Stimulating Factor for Injection
- 144药典 三部-2015 Monograph Ⅱ Therapeutic topical recombinant bovine basic fibroblast growth factor
- 126药典 三部-2010 Chapter Ⅱ Therapeutic class Anti-human T cell CD3 mouse monoclonal antibody for injection
- 120药典 三部-2010 Chapter II Therapeutic Recombinant Bovine Basic Fibroblast Growth Factor for External Use
- 121药典 三部-2010 Chapter II Therapeutic Recombinant Bovine Basic Fibroblast Growth Factor Gel
- 151药典 三部-2020 Monograph Ⅱ Therapeutic bovine basic fibroblast growth factor solution for external use
- 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
- 143药典 三部-2015 Monograph II Therapeutic Recombinant Bovine Basic Fibroblast Growth Factor Solution for External Use
- 118药典 三部-2010 Chapter II Therapeutic Recombinant Human Granulocyte Macrophage Stimulating Factor for Injection
- 148药典 三部-2020 Monograph Ⅱ Therapeutic human granulocyte-stimulating factor injection
- 91药典 三部-2010 Chapter Ⅱ Therapeutic anti-human T cell porcine immunoglobulin
- 142药典 三部-2015 Monograph II Therapeutic Recombinant Human Granulocyte Macrophage Stimulating Factor for Injection
- 117药典 三部-2010 Chapter II Therapeutic Recombinant Human Granulocyte Stimulating Factor Injection
- 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)
- 141药典 三部-2015 Monograph II Therapeutic Recombinant 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)
- 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
- 93药典 三部-2010 Chapter II Therapeutic Recombinant Human Erythropoin for Injection (CHO Cell)
- 92药典 三部-2010 Chapter Ⅱ Therapeutic Anti-human T-cell Rabbit Immunoglobulin
- 113药典 三部-2015 Monograph Ⅱ Therapeutic anti-human T cell porcine immunoglobulin
- 124药典 三部-2020 Monograph Ⅱ Therapeutic anti-human T cell porcine immunoglobulin
- 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)
- 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
- 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
Bureau of Indian Standards
- IS 18609-2024 Biotechnology-Ancillary Materials Present During the Production of Cellular Therapeutic Products and Gene Therapy Products
- IS 17711-2021 Biotechnology General requirements for transportation of cells for therapeutic use
- IS 17647-1-2021 Biotechnology - Ancillary materials present during the production of cellular therapeutic products Part 1: General requirements
- IS 17647-3-2021 Biotechnology - Ancillary materials present during the production of cellular therapeutic products Part 3: Best practice guidance for ancillary material users
- IS 17647-2-2021 Biotechnology - Ancillary materials present during the production of cellular therapeutic products Part 2: Best practice guidance for ancillary material suppliers
- IS/ISO 20404-2023 Biotechnology-Bioprocessing-General Requirements for the Design of Packaging to Contain Cells for Therapeutic Use
British Standards Institution (BSI)
- BS ISO 20399:2022 Biotechnology. Ancillary materials present during the production of cellular therapeutic products and gene therapy products
- 22/30424231 DC BS ISO 20399. Biotechnology. Ancillary materials present during the production of cellular therapeutic products and gene therapy products
- BS PD ISO/TS 20399-1:2018 Biotechnology. Ancillary materials present during the production of cellular therapeutic products-General requirements
- BS ISO 21973:2020 Biotechnology. General requirements for transportation of cells for therapeutic use
- BS PD ISO/TS 20399-3:2018 Biotechnology. Ancillary materials present during the production of cellular therapeutic products-Best practice guidance for ancillary material users
- BS PAS 83:2006 Guidance on codes of practice, standardised methods and regulations for cell-based therapeutics
- BS PD ISO/TS 20399-2:2018 Biotechnology. Ancillary materials present during the production of cellular therapeutic products-Best practice guidance for ancillary material suppliers
- 19/30354962 DC BS ISO 21973. Biotechnology. General requirements for transportation of cells for therapeutic use
- BS ISO 20404:2023 Biotechnology. Bioprocessing. General requirements for the design of packaging to contain cells for therapeutic use
Korean Agency for Technology and Standards (KATS)
- KS J ISO 20399-2025 Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products
- 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 J ISO TS 20399-1-2019(2024) Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
- KS P 1600-2007 General guideline of safety test for the cell based therapeutic substances
- KS J ISO TS 20399-2:2019 Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 2: Best practice guidance for ancillary material suppliers
- KS J ISO TS 20399-3:2019 Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 3: Best practice guidance for ancillary material users
- KS J ISO TS 20399-3-2019 Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 3: Best practice guidance for ancillary material users
- KS J ISO TS 20399-2-2019(2024) Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 2: Best practice guidance for ancillary material suppliers
- KS J ISO TS 20399-3-2019(2024) Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 3: Best practice guidance for ancillary material users
- KS J ISO TS 20399-2-2019 Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 2: Best practice guidance for ancillary material suppliers
Danish Standards Foundation
- DANSK DS/ISO 20399:2022 Biotechnology – Ancillary materials present during the production of cellular therapeutic products and gene therapy products
- DANSK DS/ISO 21973:2020 Biotechnology – General requirements for transportation of cells for therapeutic use
- DANSK DS/ISO/TS 20399-1:2018 Biotechnology – Ancillary materials present during the production of cellular therapeutic products – Part 1: General requirements
- DANSK DS/ISO/TS 20399-3:2018 Biotechnology – Ancillary materials present during the production of cellular therapeutic products – Part 3: Best practice guidance for ancillary material users
- DANSK DS/ISO/TS 20399-2:2018 Biotechnology – Ancillary materials present during the production of cellular therapeutic products – Part 2: Best practice guidance for ancillary material suppliers
- DANSK DS/ISO 20404:2023 Biotechnology – Bioprocessing – General requirements for the design of packaging to contain cells for therapeutic use
International Organization for Standardization (ISO)
- ISO 20399:2022 Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products
- ISO 21973:2020 Biotechnology — General requirements for transportation of cells for therapeutic use
- ISO/TS 20399-1:2018 Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
- ISO/TS 20399-2:2018 Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 2: Best practice guidance for ancillary material suppliers
- ISO/TS 20399-3:2018 Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 3: Best practice guidance for ancillary material users
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
IT-UNI
- UNI ISO 21973:2021 Biotechnology - General requirements for transportation of cells for therapeutic use
Gosstandart of Russia
- GOST R ISO 21973-2023 Biotechnology. General requirements for transportation of 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
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