Parenterals & Injectables

Biography

Biography: Ben Nelson

Abstract

Trehalose is a non-reducing disaccharide consisting of two glucose molecules linked by an α, α–1,1 bond. There are several properties of trehalose which make it an excellent choice for the stabilization of pharmaceutical formulations. The glass transition temperature is between 110 and 120°C, which is the highest of the disaccharides. Trehalose has 8 equatorial OH groups facilitating its inclusion into water clusters of relatively small size. It does not exhibit configurational changes caused by intramolecular hydrogen bonds like other sugars. The glycosidic bond of trehalose is <1 kcal/mol, in comparison, the sucrose glycosidic bond free energy = 27 kcal/mol. This low free energy bond is much less susceptible to hydrolysis, preventing production of reducing sugars. This work compares grades of trehalose with respect to purity, endotoxin levels, and trace metal content. Pfanstiehl Brand, High Purity Low Endotoxin Trehalose is used in the biopharmaceutical industry to stabilize proteins, lipids, and carbohydrates throughout the formulation and freeze/thaw life cycle of therapeutics. It is also widely applied as a key component in cryopreservation/freeze media to stabilize cell membranes and improve the recovery and robustness of cells used for bioproduction and cell therapy. The stabilizing benefits of trehalose include but are not limited to: Monoclonal Antibodies (mAbs), Fusion Proteins, Antibody Fragments (fAbs), Peptides, Stem cells, and Vaccines.