GMP Human Thrombopoietin Protein
优势特色（Features）
Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory
FDA DMF filed
Animal-Free materials
Beta-lactam materials free
Batch-to-batch consistency
Stringent quality control tests
表达区间及表达系统（Source）
GMP Human Thrombopoietin Protein (GMP-THNH25) is expressed from human 293 cells (HEK293). It contains AA Ser 22 - Gly 353 (Accession # P40225-1).
Predicted N-terminus: Ser 22
蛋白结构（Molecular Characterization）
This protein carries no "tag".
The protein has a calculated MW of 35.5 kDa. The protein migrates as 75 kDa±5 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) condition (SDS-PAGE) due to glycosylation.
内毒素（Endotoxin）
Less than 10 EU/mg by the LAL method / rFC method.
宿主蛋白残留（Host Cell Protein）
0.5 ng/µg of protein tested by ELISA.
宿主核酸残留（Host Cell DNA）
0.02 ng/μg of protein tested by qPCR.
无菌（Sterility）
The sterility testing was performed by membrane filtration method described in USP<71> and Ph. Eur. 2.6.1.
支原体（Mycoplasma）
Negative.
纯度（Purity）
>95% as determined by SDS-PAGE.
制剂（Formulation）
Lyophilized from 0.22 μm filtered solution in 20 mM NaAc-HAc, pH5.0 with protectants.
Contact us for customized product form or formulation.
运输（Shipping）
This product is supplied and shipped with blue ice, please inquire the shipping cost.
存储（Storage）
Upon receipt, store it immediately at -20°C or lower for long term storage.
Please avoid repeated freeze-thaw cycles.
This product is stable after storage at:
-20°C to -70°C for 5 years in lyophilized state;
-70°C for 12 months under sterile conditions after reconstitution.
背景介绍
Thrombopoietin (Tpo), is a key regulator of megakaryocytopoiesis and thrombopoiesis. It is principally produced in the liver and is bound and internalized by the receptor Tpo R/c-mpl. Defects in the Tpo-Tpo R signaling pathway are associated with a variety of platelet disorders (1-3). The 353 amino acid (aa) human Tpo precursor is cleaved to yield the 332 aa mature protein. Mature human Tpo shares approximately 70% aa sequence homology with mouse and rat Tpo. It is an 80 85 kDa protein that consists of an N terminal domain with homology to Erythropoietin (Epo) and a C terminal domain that contains multiple N linked and O-linked glycosylation sites (4, 5). Tissue specific alternate splicing of human Tpo generates multiple isoforms with internal deletions, insertions, and/or C terminal substitutions (6). Tpo promotes the differentiation, proliferation, and maturation of MK and their progenitors (4, 5, 7). Several other cytokines can promote these functions as well but only in cooperation with Tpo (8, 9). Notably, IL-3 independently induces MK development, although its effects are restricted to early in the MK lineage (8, 9). Tpo additionally promotes platelet production, aggregation, ECM adhesion, and activation (10-13). It is cleaved by platelet-derived thrombin following Arg191 within the C terminal domain and subsequently at other sites upon extended digestion (14). Both full length Tpo and shorter forms circulate in the plasma, with the shorter, N terminal EPO-like domain forms showing significantly increased specific activity (4, 5, 15). The C terminal domain is not required for binding to Tpo R or inducing MK growth and differentiation (5). Aside from its hematopoietic effects, Tpo is expressed in the brain where it promotes the apoptosis of hypoxia-sensitized neurons and inhibits neuronal differentiation by blocking NGF induced signaling (16, 17).
ACRO GMP产品制造规范
ACROBiosystems GMP级产品是在质量管理体系下生产的，并符合相关指南：
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质量管理体系内容：
1. 根据ISO 9001:2015和ISO 13485:2016进行设计，在GMP工厂进行制造和QC检测
2. 无动物成分
3. QA从批准的供应商处采购的材料
4. ISO 5洁净室和自动灌装设备
5. 人员合格
6. 质量保证审核和批准质量相关文件
7. 全批量生产和控制记录
8. 设备维护和校准
9. 分析程序的验证
10. 进行的稳定性研究
11. 全面的法规支持文件
ACROBiosystems对我们的GMP级产品提供严格的质量控制测试（经过充分验证的设备、工艺和测试方法），以确保它们在纯度、安全性、活性和批间稳定性方面符合严格的标准，每个批量QC批次主要包含以下具体信息：
1. SDS-PAGE
2. 蛋白质含量
3. 内毒素水平
4. 残留宿主细胞DNA含量
5. 残留宿主细胞蛋白质含量
6. 生物活性分析
7. 微生物检测
8. 支原体检测
9. 体外病毒测定
10. 残留水分
11. 批次间一致性
ACRO产品声明
ACROBiosystems GMP级产品专为研究、生产或离体使用而设计。注意：不可直接供人体使用。
关键字： GMP TPO;Thrombopoietin;Thrombopoietin蛋白;ACRO;百普赛斯;
百普赛斯集团ACROBiosystems Group（股票代码：301080）是成立于2010年的跨国生物科技公司，是为全球生物医药、健康产业领域提供关键生物试剂产品及解决方案的行业平台型基石企业。2021年在创业板上市。百普赛斯集团业务遍布全球，横跨亚洲、北美洲、欧洲，在中国、美国、瑞士等12个城市设有办公室、研发中心及生产基地。目前累计服务客户超6000家，与全球Top 20医药企业均建立了长期、稳定的合作伙伴关系。集团旗下拥有品牌ACROBiosystems百普赛斯、bioSeedin柏思荟、Condense Capital垦拓资本和ACRODiagnostics百斯医学等。