GMP-grade Proteins
Good Manufacturing Practices
- R&D GMP는 엄격한 규제에 맞춰서 생산됩니다!
– ISO 9001. 2015, ISO 13485:2016-certified facility
– USP Chapter <1043>, Acillary 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
- 다양한 Safety test를 통해 Cell therapy 사용에 문제가 없습니다
– Endotoxin level – Viral test – Stability test – Biological potency test
GMP 제품 List
| GMP Proteins | |||
|---|---|---|---|
| Activin A | GDNF | IL-11** | PDGF-BB* |
| BDNF | GM-CSF* | IL-12 | Periostin |
| BMP-2 | HGF | IL-15* | SCF/c-kit Ligand* |
| BMP-4 | IFN-γ* | IL-17E* | Sonic Hedgehog* |
| BMP-7 | IGF-I* | IL-21 | TGF-β1** |
| EGF* | IL-1α | KGF/FGF-7 | TGF-β3** |
| Dkk-1 | IL-1β* | LR3 IGF-I* | TNF-α* |
| FGF basic* | IL-2* | M-CSF* | VEGF** |
| Fibronectin** | IL-3* | Noggin | Wnt-3a |
| Flt-3 Ligand** | IL-4* | NRG1-b1 | PDGF-AA |
| GDF-8/Myostatin | IL-6* | NT-3 | |
| GDF-11 | IL-7* | NT-4 | |
* Animal Free / ** Animal Component Free Protein
| GMP Proteins | |||
|---|---|---|---|
| Name | Description | ||
| DAPT | γ-Secretase Inhibitor; NOTCH Pathway Inhibitor | ||
| SB431542 | TGF-β1, ALK4 and ALK7 Inhibitor | ||
| Y-27632 | Selective ROCK Inhibitor | ||
| CHIR 99021 | GSK-3 Inhibitor, WNT Pathway Activator | ||
| XAV939 (출시예정) | Tankyrase Inhibitor, WNT Signaling Inhibitor | ||
