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Primary Cell Therapy

Primary Cell Therapy, Total:117 items.

In the international standard classification, Primary Cell Therapy involves: Biology. Botany. Zoology, Medical sciences and health care facilities in general, Vocabularies, Laboratory medicine, HEALTH CARE TECHNOLOGY, Construction materials, Medical equipment, Quality, Dentistry, Services, Pharmaceutics, Structure and structure elements, Farming and forestry.


Group Standards of the People's Republic of China, Primary Cell Therapy

  • T/CSCB 0008-2021 Primary human hepatocyte
  • T/SDHCST 001-2023 General Principles on the Non-Clinical Studies of the Cell Therapy Medical Products
  • T/CMBA 021-2023 Specification of quality management for ancillary materials present during the production of cellular therapeutic products
  • T/SDHCST 008-2023 Procedures for Immunogenicity and Immunotoxicity of the Cell Therapy Medical Products
  • T/SBX 055-2022 Test methods for tumorigenicity of stem cell therapy products
  • T/CMBA 013-2021 Specification for hospital in management of clinical application of chimeric antigen receptor T cell marketed products
  • T/SHPPA 023-2023 Long term follow-up study guidance for CAR-T cell therapy products
  • T/CHSA 004-2022 Expert consensus on surgical treatment of squamous cell carcinoma of tongue mucosa
  • T/SDHCST 005-2023 Procedures for Safety Pharmacology Testing of the Cell Therapy Medical Products
  • T/SDHCST 002-2023 Test Substance Requirements on the Non-Clinical Studies of the Cell Therapy Medical Products
  • T/CI 307-2024 Quality requirements of mesenchymal stem cells for therapy
  • T/CGCPU 027-2023 Design specifications for clinical research protocol of immunotherapy
  • T/SDHCST 006-2023 Procedures for Single Dose Toxicity Testing of the Cell Therapy Medical Products
  • T/SDHCST 007-2023 Procedures for Repeated Dose Toxicity Testing of the Cell Therapy Medical Products
  • T/CAPC 011-2023 Standardized method for pharmaceutical service of pharmacies retailing Chimeric antigen receptor T cell
  • T/CAPC 011-2024 Standardized method for pharmaceutical service of pharmacies retailing Chimeric antigen receptor T cell
  • T/WEBIO 0001-2023 Specification of human primary cell preparation and quality control
  • T/SHPPA 021-2023 Import and export management guidance for CAR-T cell therapy products and their materials
  • T/SHQAP 003-2023 Guidelines for application of space separative closed systems for cell therapies production
  • T/CACM 1369-2021 Guidelines for clinical diagnosis and treatment of high altitude polycythemia in Chinese medicine
  • T/SHPPA 019-2023 Guidance for the manufacturing quality management of plasmids used in the production of Immune cell therapy products
  • T/SDHCST 004-2023 Animal Species and Model Selection for Non-clinical Studies 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/SHPPA 012-2022 Validation technical requirements for rapid sterility testing method of cellular and gene therapy products
  • T/CRHA 054-2024 Nursing technical operation specifications for hemodilution therapy for high altitude polycythemia
  • T/GDPHA 001-2023 Clinical Practice Guidelines for Subarachnoid Transplantation of Human Mesenchymal Stem Cells for the Treatment of Traumatic Spinal Cord Injury

Professional Standard - Agriculture, Primary Cell Therapy

Hebei Provincial Standard of the People's Republic of China, Primary Cell Therapy

  • DB13/T 5332-2021 Technical specification for clinical operation of cellular immunotherapy
  • DB13/T 804-2006 Technical regulations for the prevention and treatment of leukocytozoonosis in chickens

Shanghai Provincial Standard of the People's Republic of China, Primary Cell Therapy

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

American Society for Testing and Materials (ASTM), Primary Cell Therapy

  • ASTM F3368-19 Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products
  • ASTM F320-94(1999) Standard Test Method for Hail Impact Resistance of Aerospace Transparent Enclosures
  • ASTM F3209-16 Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy

SCC, Primary Cell Therapy

  • BS 1335:1968 Specification for air depolarized primary cells
  • BS 1335:1946 Specification for air depolarized primary cells
  • DANSK DS/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
  • 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
  • BS PD ISO/TS 20399-1:2018 Biotechnology. Ancillary materials present during the production of cellular therapeutic products-General requirements
  • DANSK DS/ISO 23033:2021 Biotechnology – Analytical methods – General requirements and considerations for the testing and characterization of cellular therapeutic products
  • 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 23565:2021 Biotechnology – Bioprocessing – General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use
  • BS PD ISO/TS 23565:2021 Biotechnology. Bioprocessing. General requirements and considerations for equipment systems used in the manufacturing 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 PD CEN ISO/TS 5499:2024 Health informatics. Clinical particulars. Core principles for the harmonization of therapeutic indications terms and identifiers
  • 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
  • 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

Korean Agency for Technology and Standards (KATS), Primary Cell Therapy

  • KS P 1600-2023 General guideline of safety test for the cell based therapeutic substances
  • 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

KR-KS, Primary Cell Therapy

  • KS P 1600-2018(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 20399-2-2019 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

IT-UNI, Primary Cell Therapy

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

International Organization for Standardization (ISO), Primary Cell Therapy

  • 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
  • ISO/TS 20399-1:2018 Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
  • 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 20399-3:2018 Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 3: Best practice guidance for ancillary material users
  • 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

British Standards Institution (BSI), Primary Cell Therapy

  • BS ISO 21973:2020 Biotechnology. General requirements for transportation of cells for therapeutic use
  • 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
  • 20/30369896 DC BS ISO 23033. Biotechnology. Analytical methods. General guidelines for the characterization and testing of cellular therapeutic products
  • BS ISO 23033:2021 Biotechnology. Analytical methods. General requirements and considerations for the testing and characterization of cellular therapeutic products
  • PD ISO/TS 23565:2021 Biotechnology. Bioprocessing. General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use
  • PD CEN ISO TS 5499:2024 Health informatics — Clinical particulars — Core principles for the harmonization of therapeutic indications terms and identifiers

GOST, Primary Cell Therapy

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

国家药监局, Primary Cell Therapy

  • YY/T 1465.6-2019 Methods for evaluating the immunogenicity of medical devices Part 6: Determination of animal spleen lymphocyte subpopulations by flow cytometry

国家食品药品监督管理局, Primary Cell Therapy

  • YY/T 1500-2016 Medical device pyrogen test Monocyte activation test Human whole blood ELISA method
  • YY/T 1465.4-2017 Methods for evaluating the immunogenicity of medical devices Part 4: In vivo test of phagocytosis of chicken red blood cells by mouse peritoneal macrophages
  • YY/T 1465.3-2016 Methods for evaluating immunogenicity of medical devices Part 3: Plaque-forming cell assay agar solid phase method

Yunnan Provincial Standard of the People's Republic of China, Primary Cell Therapy

  • DB53/T 328.9-2012 Experimental tree shrew part 9: HCV infection tree shrew primary liver cell model making

Danish Standards Foundation, Primary Cell Therapy

  • DS/ISO 23033:2021 Biotechnology – Analytical methods – General requirements and considerations for the testing and characterization of cellular therapeutic products
  • DS/ISO/TS 23565:2021 Biotechnology – Bioprocessing – General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use

Inner Mongolia Provincial Standard of the People's Republic of China, Primary Cell Therapy

  • DB15/T 2555-2022 Technical regulations for isolation, culture and identification of primary dairy cow mammary gland epithelial cells - milk separation method

Professional Standard - Medicine, Primary Cell Therapy

  • YY/T 1465.1-2016 Immunogenic evaluation method of medical devices.Part 1: T Lymphocyte transformation test in vitro

API - American Petroleum Institute, Primary Cell Therapy

  • API PUBL 33-31751-1986 EVALUATION OF THE POTENTIAL OF PS-8-76D5-ARO TO INDUCE UNSCHEDULED DNA SYNTHESIS IN PRIMARY RAT HEPATOCYTE CULTURES
  • API PUBL 32-32407-1985 EVALUATION OF THE POTENTIAL OF RO-1@ 81-15@ AND PS8-76D5 SAT TO INDUCE UNSCHEDULED DNA SYNTHESIS IN PRIMARY RAT HEPATOCYTE CULTURES

European Committee for Standardization (CEN), Primary Cell Therapy

  • EN ISO 10993-5:1999 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity ISO 10993-5:1999; Supersedes EN 30993-5:1994

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