GMP & Ancillary Material Grade Small Molecules
Tocris 以對品質的承諾而聞名，可透過一系列優質輔助試劑支持新細胞療法的開發。Tocris 的 GMP 和輔助材料級化合物是在具有 ISO 9001 認證使用嚴格控管流程和品質管理系統，旨在用於細胞和基因療法的製造。GMP 等級的小分子在幹細胞療法作為輔助性試劑 (ancillary reagents)。輔助性試劑用於幹細胞的重編程、擴增和分化，但不會出現在最終產品中。幹細胞作為再生醫學療法具有巨大的潛力。作為幹細胞療法輔助材料的小分子需要安全、可靠、一致和有品質保證，以確保幹細胞療法的安全性。Tocris 的 GMP 小分子依據 cGMP 指南生產，品質可以保證。
Tocris Product Quality Attributes
|
Standard Catalog |
Ancillary Material Grade |
GMP |
|
|
ISO 9001 |
✓ |
✓ |
✓ |
|
QC Testing |
✓ |
✓ |
✓ |
|
Controlled Manufacturing Zone |
✓ |
✓ |
|
|
ISO-7 Cleanroom |
✓ |
✓ |
|
|
Endotoxin/Bioburden Testing |
✓ |
✓ |
|
|
TSE and BSE Certification |
✓ |
✓ |
|
|
Risk-based Approach to Manufacturing |
✓ |
||
|
ICH Q7 |
✓ |
GMP Small Molecules 產品
|
Product Name |
Catalog # |
Description |
|
CHIR 99021 |
TB4423-GMP |
GSK-3 Inhibitor and WNT pathway activator. Enables reprogramming of human somatic cells into iPSCs |
|
LDN 193189 |
TB6053-GMP |
Potent and selective ALK2 and ALK3 inhibitor. Promotes neural induction of hPSCs |
|
SB 431542 |
TB1614-GMP |
TGF Beta 1 (TGF-β1), ALK4 and ALK7 Inhibitor. Replaces SOX2 in reprogramming of fibroblasts to iPSCs |
|
XAV 939 |
TB3748-GMP |
Tankyrase Inhibitor; inhibits WNT signaling. Promotes cardiomyocyte differentiation from ESCs |
|
Y-27632 |
TB1254-GMP |
Selective ROCK Inhibitor. Increases survival of ESCs and iPSCs undergoing cryopreservation |