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基于iPSC的细胞疗法CMC生产工艺解决方案

使用诱导多能干细胞(iPSCs)进行的研究已彻底改变了再生医学并加速了人类疾病的研究进程。iPSCs独特的自我更新特性和可被基因工程编辑的能力可以产生几乎无限数量的成熟的分化细胞类型，包括免疫细胞（T细胞、NK细胞及巨噬细胞等）、神经元、胰岛细胞等。
ACROBiosystems百普赛斯专注于支持细胞疗法相关研究，在完善的细胞培养平台、抗体开发平台、流式细胞术验证平台以及GMP质量管理体系下，开发了一系列用于iPSC的CMC生产工艺相关产品，帮助客户加速生产流程，全面助力基于iPSC疗法的开发进程。

培养扩增

培养扩增产品列表

coin GMP Human Laminin 521 Protein 特色产品

coin Human Laminin 511 Protein, premium grade

coin Human Vitronectin / VTN Protein

coin GMP Human FGF basic Protein

coin Human TGF-Beta 1/TGFBl Protein, premium grade

coin Human LlF Protein

培养扩增

产品优势

高性能 - 人PSC的快速扩增和PSC向多种靶细胞分化能力的增强

更好的贴壁性能 - 在低至2ug/ml的浓度下仍保持良好的贴壁性能

干性维持 - hPSC培养数代后未观察到自发分化

批间一致性 - 由稳定的细胞系、稳健的纯化工艺和严格的QC生产

支持大规模临床级供应 - 严格遵守GMP管理体系，支持多国法规，稳定供应生产

产品验证数据

GMP Laminin521 Validation Data
GMP Laminin521 Validation Data

Laminin 521 (GMP-LA5H24) effectively maintains the expansion of human iPSCs.

GMP Laminin521 Validation Data

Laminin 521 (GMP-LA5H24) could maintain the stemness of iPSC after several passages

GMP Laminin521 Validation Data

Normal karyotype (46, XX) was found in hiPSCs with Laminin 521(GMP-LA5H24) coating after 10 passages.

GMP FGF basic-Stemness maintenance
GMP FGF basic-Stemness maintenance

FGF basic (GMP-FGCH17) could highly support stemness maintenance in ESC/iPSC compared to other companies.

相关产品推荐

间充质干细胞培养用细胞因子 icon

神经干细胞培养用细胞因子 icon

胚胎干细胞培养用细胞因子 icon

造血干细胞培养用细胞因子 icon

基因编辑

基因编辑产品列表

coin GMP GENPower NLS-Cas9 Nuclease

coin GENPower NLS-Cas9 Nuclease,premium grade

产品优势

高纯度、高酶活、高切割效率

具有核定位信号，增强编辑效率

无菌、超低内毒素

在符合GMP的工厂进行生产并进行QC测试

产品验证数据

GMP FGF basic-Stemness maintenance

Different amounts of Cas9 were incubated with the same amount of excess gRNA and plasmid for 60 minutes at 37°C. When using 400-200 ng Acro Cas9, the cutting efficiency is greater than 90%. In comparison, when using a 200 ng Competitor T, the cutting efficiency is only about 50%.

相关产品推荐

resDetect Cas9 (CRlSPR Associated Protein 9) ELlSA Kit (Residue Testing) icon

GENPowerm NLS-Cas12a Nucleaseicon

诱导分化

  • iPSC-T细胞
  • iPSC-NK细胞
  • iPSC-神经细胞

iPSC-T细胞

iPSC-T_Workflow

iPSC-T细胞产品列表

DLL4GMP级-特色产品 VCAM-1 GMP级-特色产品 SCF Flt-3 Ligand TPO VEGF 165 BMP-4 FGF basic IL-7 IL-15 IL-21 IL-2 IL-3 OKT3 Anti-CD28 antibody 点击查看更多产品列表 >>
iPSC-T细胞产品列表

产品优势

GMP级别DLL4, VCAM1：支持feeder free体系，高效促进iPSC向免疫细胞分化。

产品活性均经过iPSC来源的T细胞分化验证

生产和质量控制在严格的GMP体系下，符合多国法规

全方位质量放行验证，16项质量控制指标

更好的安全性（无菌、无支原体、无外源病毒，无动物源生产体系及各项杂质残留检测）

药品级生产厂房

支持线上线下审计

完成FDA DMF备案

产品验证数据

DLL4-Fc coated plate supports CD5+CD7+ T-cell progenitor differentiation from CD34+ HSPC
DLL4-Fc coated plate supports CD5+CD7+ T-cell progenitor differentiation from CD34+ HSPC

GMP Human DLL4 Protein, Fc Tag (GMP-DL4H28), together with SCF, TPO and other factors, could promote human CD34+CD45+ hematopoietic cells to differentiate into thymocyte (T) cell progenitors.

DLL4&VCAM-1 support CD5+CD7+ T-cell progenitor differentiation from CD34+ HSPC
DLL4&VCAM-1 support CD5+CD7+ T-cell progenitor differentiation from CD34+ HSPC

DLL4 (GMP-DL4H28) & VCAM1 (GMP-VC1H25) could highly support CD5+CD7+ T-cell progenitor differentiation from CD34+ HSPC.

资源分享

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手册下载

ClinMax
resDetect
免疫细胞疗法

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Manufacture Residue Kits

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HCD detection

resDetect E. coli HCD Kit icon

resDetect HEK293 HCD Kit icon

resDetect CHO HCD Kiticon

Enzyme residue kit

DNase Activity Assay Kit (Fluorescence)icon

RNase Activity Assay Kit(Fluorescence)icon

GENIUS"Nuclease ELISA Kiticon

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Mono-growth factor detection

ClinMax ELISA Kit: lL-1B, IL-2, IL-4, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-15, IL-17, GM-CSF, TNF-alpha, lFN-gamma, etc.icon

Multiplex detection

Th1/Th2 Cytokine Kit (Flow Cytometry Multiplex Bead Assay)icon

  • 背景
  • 培养扩增
  • 基因编辑
  • 诱导分化
  • 资源分享