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GMP级别细胞因子

GMP级别细胞因子
背景
以CAR-T\NK为代表的免疫细胞疗法在白血病、淋巴瘤、多发性骨髓瘤等多种恶性肿瘤疾病的治疗中展现出显著的治疗效果而成为国内外研究的热点,目前全球已有多款细胞治疗药物被FDA批准上市。随着越来越多的免疫细胞疗法进入临床研究和上市申请阶段,对应的质量和生产管理规范问题也越来越受到行业的关注。在免疫细胞治疗产品的生产过程中,培养基补充剂如IL-15、IL-7以及IL-21等细胞因子是T\NK免疫细胞增殖分化的主要试剂,是免疫细胞治疗药物生产的关键原材料。FDA和《中国药典》对这些关键物料的使用均有相关规定,其中FDA CMC建议使用FDA批准的或者临床级别的物料,国内规定使用的原材料要优先选择低风险级别的,比如建议使用GMP级的材料优于非GMP级。因此使用安全性、有效性以及符合规范的细胞因子对于免疫细胞治疗药物的成功研发和顺利申报上市至关重要。
ACROBiosystems百普赛斯致力于开发高质量的,应用于免疫细胞治疗药物临床阶段的相关试剂,特在拥有GMP级质量管理体系平台的基础上,结合细胞治疗药物生产规范,以更严格的质量管理和药品级放行检测标准,成功开发了一系列如IL-15,IL-7, IL-21等高质量的GMP级别细胞因子*。ACRO GMP级细胞因子* 可更好助力免疫细胞治疗药物的临床研究,加速临床、上市申报进程。
*ACROBiosystems GMP级产品是为研发,生产或体外使用而设计的,不能直接用于人体。

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ACROBiosystems GMP级别产品质量生产规范
GMP质量管理体系

经ISO 9001:2015 和 ISO 13485:2016认证

生产厂房具备药品生产许可证

药品B+A级洁净室和自动灌装设备

无菌技术与二级除菌过滤

无动物源性材料和生产环境

人员培训体系

供应商和原材料管理体系

质量文件/记录经QA审查和批准

完整的批生产和检验记录

设备维护和校准程序

分析方法的验证

完整的法规支持文档(RSF)

点击咨询完整的法规支持文档(RSF)

全自动灌装设备
全自动灌装设备
灭菌设备
灭菌设备
全方位质量放行验证 (以GMP IL-15放行标准为例)

细胞活性高于0.8 x 107 IU/mg

纯度高于95%

内毒素低于10EU/mg

宿主DNA残留低于0.02ng/ug

宿主蛋白残留低于0.5ng/ug

无菌检测

支原体检测

外源病毒检测

高批间一致性

全面的稳定性数据支持(加速,冻融,长期,运输稳定性验证)

体内安全性数据

产品特色

药典标准放行

- 16项质量控制指标

- 更好的安全性(无菌,支原体,外源病毒,各项杂质残留检测)

- 高稳定性和批间一致性

更严格GMP质量管理体系

- 药品级生产厂房

- 药用级物料/包材

- 支持线上/线下审计

加速临床/上市申报

- 完整的细胞/基因治疗产品申报支持文档

- 提供全套方法学验证报告

- 已完成FDA DMF备案

产品列表
分子 货号 产品描述 订购/预购
IL-15 GMP-L15H13 GMP Human IL-15

立即订购

IL-7 GMP-L07H24 GMP Human IL-7

立即订购

IL-21 GMP-L21H25 GMP Human IL-21

预购

更多GMP级别产品
分子 货号 产品描述 订购/预购
CD3 GMP-MC0323 GMP Monoclonal Anti-Human CD3 Antibody(OKT3)

立即订购

CD28 GMP-MC2824 GMP Monoclonal Anti-Human CD28 Antibody

预购

BenzNuclease GMP-NUES19 GMP GENIUS™ Nuclease

预购

Cas9 GMP-CA9S19 GMP NLS-Cas9 Nuclease

预购

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验证数据

高纯度

SDS-PACE 纯度>95%

SDS-PACE 纯度>95%

高生物活性

BCMA

刺激CTLL-2 细胞增殖实验结果显示,GMP Human IL-15 (GMP-L15H13)的细胞活性高于0.8 ⅹ10^7 IU/mg(经WHO Human IL-15标品校准,NIBSC 代码:95/554)。

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高稳定性

加速和冻融稳定验证
GMP-L15H13

GMP Human IL-15 (GMP-L15H13)在25℃加速8/24/48/72h条件下和冻融三次后,细胞活性均保持不变。

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长期稳定性检测(25℃)
GMP-L15H13

GMP Human IL-15 (GMP-L15H13)在25℃下储存90d,细胞活性无下降。

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高批间一致性

GMP-L15H13

GMP Human IL-15 (GMP-L15H13)不同批次的细胞活性保持一致,具有高批间一致性。

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相关说明

MANUFACTURING SPECIFICATIONS

MANUFACTURING SPECIFICATIONS

ACROBiosystems GMP grade products are produced under a quality management system and in compliance with relevant guidelines: Ph. Eur General Chapter 5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products; USP <92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing; USP <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products; ISO/TS 20399-1:2018, Biotechnology - Ancillary Materials Present During the Production of Cellular Therapeutic Products.


ACROBiosystems Quality Management System Contents:

  1. Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory.
  2. Animal-Free materials
  3. Materials purchased from the approved suppliers by QA
  4. ISO 5 clean rooms and automatic filling equipment
  5. Qualified personnel
  6. Quality-related documents review and approve by QA
  7. Fully batch production and control records
  8. Equipment maintenance and calibration
  9. Validation of analytical procedures
  10. Stability studies conducted
  11. Comprehensive regulatory support files


ACROBiosystems provide rigorous quality control tests (fully validated equipment, processes and test methods) on our GMP grade products to ensure that they meet stringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:

  1. SDS-PAGE
  2. Protein content
  3. Endotoxin level
  4. Residual Host Cell DNA content
  5. Residual Host Cell Protein content
  6. Biological activity analysis (Reference the WHO Human IL-15 (NIBSC code: 90/530) as standard)
  7. Microbial testing
  8. Mycoplasma testing
  9. In vitro virus assay
  10. Residual moisture
  11. Batch-to-batch consistency


DISCLAIMER

ACROBiosystems GMP grade products are designed for research, manufacturing use or ex vivo use. CAUTION: Not intended for human in vivo applications.

TERMS AND CONDITIONS

TERMS AND CONDITIONS

All products are warranted to meet ACROBiosystems Inc.’s (“ACRO”) published specifications when used under normal laboratory conditions.


ACRO DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS. IN PARTICULAR, ACRO DOES NOT MAKE ANY WARRANTY OF SUITABILITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

NOT WITH STANDING ANY OTHER PROVISIONS OF THESE TERMS AND/OR ANY OTHER AGREEMENT BETWEEN ACRO AND PURCHASER FOR THE PURCAHSE OF THE PRODUCTS, ACRO’S TOTAL LIABILITY TO PURCHASER ARISING FROM OR IN RELATION TO THESE TERMS, AN AGREEMENT BETWEEN THE PARTIES OR THE PRODUCTS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PURCHASER TO ACRO FOR THE RELEVANT PRODUCTS. IN NO EVENT WILL ACRO BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS.

END USER TERMS OF USE OF PRODUCT

The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product. If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.

The End User is aware that ACROBiosystems Inc. and its affiliate (“ACRO”) sell GMP grade products designed for research, manufacturing use or ex vivo use and not intended for human in vivo applications. The End User further agrees, as a condition of the sales of ACRO’s GMP grade products that: a) the End User will not use this GMP grade product in any procedure wherein the product may be directly or indirectly administered to humans, unless the End User has obtained, or prior to their use will have obtained, an Investigational New Drug (IND) exemption from the FDA and will use the product only in accordance with the protocols of such IND and of the Institutional Review Board overseeing the proposed research, or b) the End User will use the products outside of the United States in accordance with the protocols of research approved by the applicable review board or authorized ethics committee and regulatory agencies to which the End User is subject to in their territory.

参考文献

  • [1] Libby, Kendra A, and Xiaolei Su. Imaging Chimeric Antigen Receptor (CAR) Activation[J]. Methods in molecular biology. 2020, 153-160.
  • [2] 生物制品生产用原材料及辅料的质量控制规程—中国药典
  • [3] Corrected Draft Guidance for Industry: Chemistry, Manufacturing,and Control(CMC) Information for Human Gene Therapy Investigation New Durg Applications(INDs). FDA, CBER, 2018.7.20

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