Liraglutide
GLP-1 analogue; 60 kg a year from a 1,000 L tank.
A GLP-1 analogue that raises insulin release and lowers glucagon in a glucose-dependent way, slows gastric emptying and reduces appetite. Made by fermentation and semi-synthesis: high solubility, low aggregation, high in-vitro activity.
Chemical identity
- CAS number
- 204656-20-2
- Molecular weight
- 3751 g/mol
- InChIKey
- YSDQQAXHVYUZIW-QCIJIYAXSA-N
- PubChem CID
- 16134956
Specification
| Made by | E. coli fermentation and semi-synthesis |
| Peptide map | Same as reference (batch result: complies) |
| Hydrophilic impurities | ≤ 2.5 % (batch result: 0.4 %) |
| Hydrophobic impurities | ≤ 0.5 % (batch result: 0.2 %) |
| Total impurities | ≤ 5.2 % (batch result: 1.4 %) |
| High-molecular-weight proteins | ≤ 0.7 % (batch result: 0.04 %) |
| Bioburden | < 100 cfu/g (batch result: complies) |
| Bacterial endotoxin | < 10 EU/mg (batch result: complies) |
| Host cell protein | < 100 ng/mg (batch result: complies) |
| Ethanol | ≤ 5,000 ppm (batch result: 54 ppm) |
| Acetonitrile | ≤ 410 ppm (batch result: 55 ppm) |
| Triethylamine | ≤ 5,000 ppm (batch result: not detected) |
- 1,000 L fermentation tank, 60 kg a year.
- Stability studies and support for a DMF application.