Low endotoxin trehalose dihydrate EP, USP-NF, JP
Technical name: α,α-D-Trehalose
Empirical formula: C12H22O11.2H2O
Molecular weight: 342.3 + 36.0
Trehalose is a non-reducing disaccharide consisting of two molecules linked by an α,α-1,1 bond. There are several properties of trehalose that make it an excellent stabilizer in biopharmaceutical formulations. In particular, trehalose is used to stabilize protein-based pharmaceuticals, such as monoclonal antibodies in injectables and other protein molecules that are often degraded by freezing, lyophilization and storage for long periods.
Trehalose demonstrates exceptional stability. It is not easily hydrolyzed by acid and the glycosidic bond is not cleaved by α-glycosidase. Trehalose is typically found in the dihydrate form and it is characterized by its low hygroscopicity. The water content of the dihydrate crystal remains stable at approximately 9.5% during exposure to relative humidity up to 92%. During various desiccation processes, including freeze drying and spray drying, trehalose readily dries as an amorphous material with high glass transition temperature (Tg > 100°C), the highest of the disaccharides. Compared to sucrose, trehalose Tg is about 3°C higher. This important physicochemical property is relevant for shortening drying times dramatically.
The stabilizing benefits of trehalose include but are not limited to:
- monoclonal antibodies (mAbs),
- fusion proteins,
- antibody fragments (fAbs),
- stem cells,
VIO Chemicals offers high quality low endotoxin and GMO-free trehalose dihydrate and trehalose anhydrous, for pharmaceutical and cosmetic applications, at competitive prices.
Trehalose is contained in several commercially available therapeutic products, including Herceptin®, Avastin®, Lucentis® and Advate®.
EP, USP/NF, JP