Trehalose Dihydrate NF EP JP ChP

Trehalose dihydrate is a sugar made from two glucose units linked by a strong α-1,1 bond that makes it stable in acidic and high-temperature conditions. Unlike other sugars it does not undergo glycation because its bonding keeps the glucose molecules in a closed-ring form. Trehalose is less soluble than sucrose but becomes more soluble at temperatures above 80°C. Its stability and resistance to breakdown have made it popular in biological preservation due to its cryoprotective properties.

Trehalose has a high glass transition temperature (Tg), typically around 115°C when in an anhydrous form. The glass transition temperature refers to the point at which a substance changes from a rubbery or viscous state to a glass-like, solid state. This property helps in preserving protein therapeutics by trapping proteins in a glassy matrix, effectively stabilizing them and preventing degradation.

At temperatures below the Tg, the molecules within the glassy matrix have limited mobility, which helps to reduce reactions that could otherwise damage the proteins, such as aggregation or denaturation. This makes trehalose particularly useful in protecting sensitive biologics during freeze-drying (lyophilization) and storage, where maintaining protein structure and function is critical for therapeutic effectiveness.

Low Endotoxin Trehalose is often used as excipient in protein based biologic therapeutics.  Special processing by regulated manufacturers is required to remove the naturally occurring endotoxin, bioburden, and trace metals to be considered parenteral excipient grade.

Pfanstiehl’s Trehalose dihydrate has been found to offer several benefits in the preservation of monoclonal antibodies, fusion proteins, vaccines, and stem cells.