GMP Quality Compliance
Develop your cell therapy manufacturing process with confidence by using R&D Systems™ GMP cytokines and growth factors. Our years of expertise in protein development and manufacturing, stringent quality control, and regulatory support allow us to offer industry-leading GMP proteins for ancillary use. We often use the same clone, sequence, and expression system as our RUO and animal-free grade materials to make your switch to GMP as seamless as possible.
Cytokines for Immune Cell Therapy
| Protein | Animal-Free RUO | GMP | Specialized Formats | GMP Source |
|---|---|---|---|---|
| IFN-gamma | AFL285 | 285-GMP DMF on file | E.coli | |
| IL-1 beta | AFL201 | 201-GMP | E.coli | |
| IL-2 | BT-002-AFL | BT-002-GMP DMF on file | Liquid | E.coli |
| IL-3 | AFL203 | 203-GMP | E.coli | |
| IL-4 | BT-004-AFL | BT-004-GMP DMF on file | E.coli | |
| IL-6 | AFL206 | 206-GMP DMF on file | E.coli | |
| IL-7 | BT-007-AFL | BT-007-GMP DMF on file | Liquid Process-Sized Vials | E.coli |
| IL-10 | 1064-GMP DMF on file | E.coli | ||
| IL-15 | BT-015-AFL | BT-015-GMP DMF on file | Liquid Process-Sized Vials | E.coli |
| IL-18 | Coming Soon | E.coli | ||
| IL-21 | BT-021-AFL | BT-021-GMP | Liquid | E.coli |
| TNF-alpha | AFL210 | 210-GMP | E.coli |
Cytokines & Growth Factors for Regenerative Medicine
| Protein | Animal-Free RUO | GMP | GMP Source |
|---|---|---|---|
| Activin A | 338-GMP DMF on file | CHO | |
| Betacellulin | BT-BTC-AFL | BT-BTC-GMP DMF on file | E.coli |
| BDNF | BT-BDNF-AFL | BT-BDNF-GMP DMF on file | E.coli |
| BMP-2 | 355-GMP | CHO | |
| BMP-4 | AFL314E | 314E-GMP | E.coli |
| EGF | AFL236 | 236-GMP DMF on file | E.coli |
| FGF basic/FGF2 | BT-FGFB-AFL | BT-FGFB-GMP DMF on file | E.coli |
| FGF7 | Coming Soon | ||
| Flt-3 Ligand/FLT3L | BT-FT3L-AFL | BT-FT3L-GMP DMF on file | E.coli |
| GDF-8/Myostatin | 788-GMP | NS0 | |
| GDNF | 212-GMP | NS0 | |
| GM-CSF | AFL215 | 215-GMP | E.coli |
| HGF | 294-GMP | NS0 | |
| IGF-I | AFL291 | 291-GMP DMF on file | E.coli |
| KGF/FGF-7 | 251-GMP | E.coli | |
| LR3 IGF-I | 8335D-GMP | E.coli | |
| M-CSF | AFL216 | 216-GMP | E.coli |
| Noggin Fc tag | 3344-GMP | NS0 | |
| PDGF-AA | AFL221 | 221-GMP | E.coli |
| PDGF-BB | AFL220 | 220-GMP | E.coli |
| SCF/c-kit Ligand | BT-SCF-AFL | BT-SCF-GMP DMF on file | E.coli |
| Sonic Hedgehog (C24II) N-Terminus | AFL1845 | 1845-GMP | E.coli |
| Sonic Hedgehog N-Terminus | 1314-GMP | E.coli | |
| TGF-beta 1 | 240-GMP DMF on file | CHO | |
| Thrombopoietin | 288E-GMP DMF on file | E.coli | |
| VEGF | BT-VEGF-AFL | BT-VEGF-GMP DMF on file | E.coli |
| Vitronectin | Coming Soon | ||
| Wnt-3a | 5036-GMP | CHO |
For Closed-Process Cell Therapy Manufacturing: ProPak GMP Cytokines
GMP IL-7 and IL-15 are now available in single-use weldable bags. These 1 L process-sized protein bags reduce both variability and risk for your cell therapy, plus eliminate reconstitution and aliquoting.
GMP 级重组人 IL-2 的活性、批间一致性和纯度分析
(A) 测试三个独立批次的 GMP 级重组人 IL-2（R&D Systems，货号 BT-002-GMP）刺激 CTLL-2 小鼠细胞毒性 T 细胞增殖的能力。本实验的 ED50 为 0.03-0.25 ng/mL。图上每条线代表不同生产批次的 GMP 级重组人 IL-2，展示了蛋白的批间一致性。(B, C) 使用 Maurice（ProteinSimple，货号 090-000）在还原性（R；B 图）和非还原性（NR；C 图）条件下，通过 CE-SDS 评估了 A 图中所示的三个独立批次 GMP 级重组人 IL-2 的纯度，并在 iCE分析软件 Compass 中可视化。B图和C图所示为 Compass 软件生成的凝胶视图。
GMP 级重组人 IL-7 的活性、批间一致性和纯度分析
(A) 测试三个独立批次的 GMP 级重组人 IL-7（R&D Systems，货号 BT-007-GMP）刺激 PHA 活化的人外周血淋巴细胞增殖的能力。本实验的 ED50 为 0.1-0.5 ng/mL。图上每条线代表不同生产批次的 GMP 级重组人 IL-7，展示蛋白的批间一致性。(B, C) 使用 Maurice（ProteinSimple，货号 090-000）在还原性（R；B图）和非还原性（NR；C图）条件下，通过 CE-SDS 评估了 A 图中所示的三个独立批次 GMP 级重组人 IL-7 的纯度，并在 iCE 分析软件 Compass 中可视化。B图和C图所示为 Compass 软件生成的凝胶视图。IS 条带是10 kDa Maurice CE-SDS 内标标记物（ProteinSimple，货号 046-144），添加至每份样品中以计算相对迁移时间 (RMT)。
(A) 测试三个独立批次的 GMP 级重组人 IL-10（R&D Systems，货号 1064-GMP）刺激 MC/9-2 小鼠肥大细胞增殖的能力。本实验的 ED50 为 0.0750-0.750 ng/mL。图上每条线代表不同生产批次的 GMP 级重组人 IL-10，展示蛋白的批间一致性。(B, C) 使用 Maurice（ProteinSimple，货号 090-000）在还原性（R；B 图）和非还原性（NR；C 图）条件下，通过 CE-SDS 评估 了A 图中所示的三个独立批次 GMP 级重组人 IL-10 的纯度，并在 iCE 分析软件 Compass 中可视化。B图和C图所示为 Compass 软件生成的凝胶视图。IS 条带是10 kDa Maurice CE-SDS 内标标记物（ProteinSimple，货号 046-144），添加至每份样品中以计算相对迁移时间 (RMT)。
Animal-Free GMP Proteins for Cell Therapy Manufacturing
Animal-free RUO and GMP recombinant human proteins are manufactured using equipment and reagents that are certified animal-free. Our dedicated controlled-access animal-free laboratories ensure that at no point in production are these products exposed to potential contamination by animal components or byproducts.
Transition Seamlessly from RUO to GMP
Both AF RUO and GMP grades of E.coli sourced proteins share the same sequence, source, formulation, activity and purity specifications, manufacturing site and personnel, and vial type – ensuring equivalent performance and process continuity as you transition to the clinic.
Supply Chain Continuity
It is critical to secure a stable supply of GMP-grade proteins for use as raw materials in ex vivo cell manufacturing. This becomes progressively more important during the transition from early- to late-stage clinical trials. We have the expertise and ability to scale up your GMP protein supply. Working with your process forecasting, we will provide supply and quality agreements to ensure the consistent supply of the GMP proteins you require.
- Risk mitigation management
- Secondary cell banking facility
- Quality-controlled change and notification process
GMP 质检政策和监管支持
我们根据细胞疗法生产工艺中辅助材料监管指南生产 GMP 级细胞因子和生长因子。这包括广泛的质量控制检验和全面的生产系统文档记录以及原材料的可追溯性。您可以确信，您将获得一致、安全和可追溯的原材料供应。我们定期审核自身设施，并欢迎客户审核。
请访问 GMP 生产能力，简要了解我们全球的 GMP 设施认证。
- ISO 9001:2015、ISO 13485:2016 认证，包括专用于生产 GMP 蛋白的完全无动物源设施
- USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
- Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
我们与首选原材料供应商合作以减少风险，并恪守无动物源环境的严格规定。可提供原产地证明（COO）。
- 单独记录各种测试结果，并受质量控制（QC）部门和质量保证（QA）部门审查的标准表格
- 批次专属的检验报告
- 在装运任何材料之前，对所有生产批次记录和装瓶记录执行全面的质量保证（QA）审查
- 文件变更和工艺变更的流程均有记录，受质量保证（QA）部门审查
- 人员培训计划
- 原材料检验、追踪和供应商资格确认/监控
- 设备、工艺和检验方法经充分验证
- 基于计算机校准程序的设备校验方案
- 设施维护与安全检查方案
- 物料审查委员会监督产品质量波动
- 每种产品保质期内的稳定性监测
- 产品变更通知
我们密切关注蛋白生产工艺每个层面的细节。我们的 GMP 蛋白质量管理体系包括详细的标准操作程序（SOP）和生产设备、工艺的质控文件。您可以依靠我们的 GMP 蛋白构建一致且强健的细胞疗法生产计划。
- 生物效价质量标准
- 规定的纯度质量标准
- 稳定性检验计划
- 规定的内毒素质量标准
- 宿主细胞蛋白含量检验
- 根据 USP 进行无菌检验
- 真核细胞库病毒检验和病毒减量研究 - 详情请联系我们
- 根据您的需求可提供额外的检验
我们生产的每批 GMP 蛋白都有一份记录了相关质量体系和产品规范的检验报告 (CofA)。CofA 放行前，我们对所有生产批次记录和装瓶记录执行全面 QA 审查。如下是您可以在我们的 CofA 上找到的内容：
- 小瓶实际装量（蛋白质量），帮助您精确溶解蛋白
- 来源信息
- 前 10 个氨基酸的 N 端测序
- 纯度标准
- 生物活性测定，包括针对主批次的基准化分析法
- 根据《美国药典》(USP) 进行无菌检验
- 内毒素水平
- 宿主细胞蛋白质量标准
- 宿主细胞 DNA 质量标准
- 稳定性声明
- 我们遵循的认证、监管指南
State-of-the-Art GMP Protein Manufacturing Facility
We're committed to meeting the increasing demands of therapeutic cell manufacturing. Our facility supports large-scale production of GMP-grade, E. coli-derived recombinant proteins.
- Entire facility dedicated to manufacturing GMP proteins
- Completely animal-free – No animal components are allowed in the facility
- Capacity – 61,000 sq. ft. to meet your current and future supply requirements
- Expandability – Available space to build additional capacity
- ISO 5/7/8 cleanrooms for the entire production process
