Pfanstiehl Trehalose Citation Page
Trehalose Dihydrate NF EP JP ChP
Molecular Formula
C12 H22O11 . 2H2O
CAS No
Molecular Weight
Solubility in Water
Boiling Point
Melting Point
Quality Level
Highest – Parenteral Excipient Grade cGMP
Suitable for Injectable Biologic & Vaccine formulation
Trehalose Dihydrate is a non-reducing disaccharide consisting of two glucose molecules linked by an α, α–1,1 bond and has gained acceptance in biologic stabilization applications due to its unique cryopreservative properties.
Pfanstiehl’s Trehalose dihydrate has been found to offer several benefits in the preservation of monoclonal antibodies, fusion proteins, vaccines, and stem cells.
Trehalose has been shown to protect cells and biological materials from damage caused by freezing and thawing. Its presence helps maintain the structural integrity of cell membranes and prevents the formation of ice crystals, which can be detrimental to cells.
Trehalose is known for its protein-stabilizing properties. It can help maintain the conformational stability of proteins during freezing and thawing processes, reducing the risk of protein denaturation and aggregation.
Administering highly Trehalose acts as a cryoprotectant, mitigating the harmful effects of freezing and thawing on cells and proteins. This is particularly important in the preservation of biological samples, where ice crystal formation and the associated cellular damage can be a significant concern.viscous formulations may require higher injection forces, leading to patient discomfort and potential issues with administration compliance.
When used in cryopreservation, Trehalose has been shown to improve the viability and functionality of cells and biological molecules after thawing. This is crucial for maintaining the effectiveness of vaccines, antibodies, and other biopharmaceutical products.
Trehalose allows for the long-term storage of biological materials at ultra-low temperatures without significant loss of viability or functionality. This is particularly valuable in biotechnology and pharmaceutical industries where the stability of products over time is crucial.
Pfanstiehl Trehalose Citation Page
Pfanstiehl Brand High Purity – Low Endotoxin – Low Metals
were developed specifically for biopharmaceutical formulation and commercial manufacturing and are produced under full ICH-Q7 cGMP conditions in the United States to the highest quality and purity standards.
Pfanstiehl Brand Trehalose is compliant with NF (National Formulary) EP (European) JP (Japanese) and ChP (Chinese) Pharmacopoeia
Because of these stringent manufacturing specifications and Pfanstiehl Quality Systems, you can be assured that Pfanstiehl’s Trehalose will be of the highest quality & consistency from batch to batch and the safest available for use in your manufacturing or research application.
Trehalose dihydrate
Highest – Compendial Parenteral Excipient Grade GMP
Highest Purity
Low Endotoxin
Low Metals
Low Bioburden
USP-NF
EP
JP
ChP
Parenteral Formulation
Liquid Formulation
Pharmaceutical Process
Biopharma Process
Trehalose dihydrate
Highest – Compendial Parenteral Excipient Grade GMP
Highest Purity
Low Endotoxin
Low Metals
Low Bioburden
USP-NF
EP
JP
ChP
Parenteral Formulation
Liquid Formulation
Pharmaceutical Process
Biopharma Process
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