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Trehalose Injectable Excipient Molecular Structure used to stabilize proteins in biologics and therapeutics

Trehalose Dihydrate NF EP JP ChP

a, a Trehalose dihydrate (Plant Derived) High Purity, Low Endotoxin, Low Metals - NF, EP, JP, ChP

Molecular Formula

C12 H22O11 . 2H2O

CAS No

6138-23-4

Molecular Weight

378.33

Solubility in Water

68.9 g per 100 g at 20 °C

Boiling Point

675.4 °C

Melting Point

96.5 °C

Quality Level

  • Highest – Parenteral Excipient Grade cGMP
  • Suitable for  Injectable Biologic & Vaccine Formulation
  • Suitable for Inhalation & Ophthalmic Formulation

 

Trehalose dihydrate is a sugar made of two glucose units connected by a strong α-1,1 bond making it stable in acidic and high-temperature conditions. Unlike other sugars it does not undergo glycation because its structure keeps the glucose molecules in a closed-ring form. Trehalose is less soluble than sucrose but more soluble at temperatures above 80°C. It’s stability and resistance to breakdown make it useful in biological preservation because of its cryoprotective properties.

 

Trehalose has a high glass transition temperature (Tg) which is typically around 115°C when it is anhydrous. The glass transition temperature is when a substance changes from a rubbery flexible state to a solid glass-like state. This property is helpful in preserving protein therapeutics by trapping proteins in a stable glassy form which helps prevent degradation.

 

Below the Transition Glass Temperature (Tg), molecules in the glassy state have minimal movement. This minimizes the risk of proteins aggregating or denaturing which can harm the product’s effectiveness. Trehalose is ideal for protecting sensitive biologics during freeze-drying (lyophilization) and storage and helps preserve protein structure and function for therapeutic use.

 

  • Pfanstiehl Low Endotoxin Trehalose dihydrate GMP Excipient Grade is often used as an excipient in protein-based biologic therapeutics. Special processing by regulated manufacturers is required to remove the naturally occurring endotoxin, bioburden, and trace metals for it to be considered parenteral excipient grade.

 

  • Pfanstiehl Trehalose dihydrate Inhalation Grade is a specialized formulation of Trehalose that has undergone additional processing and safety testing to ensure the lowest levels of endotoxins, residual solvents, and microbial contaminants and is designed specifically for modern inhalation medications.

 

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

Pfanstiehl Multi-Compendial Trehalose dihydrate Key Benefits:

  • Cellular Protection:
    Trehalose dihydrate by Pfanstiehl helps protect cells and biological materials from damage caused by freezing and thawing. When cells freeze, ice crystals can form and rupture cell membranes, causing damage. Trehalose prevents ice crystal formation, keeping cell membranes intact and maintaining the cell’s structure. It also helps protect proteins and lipids inside the cells, preserving their function. This makes Trehalose essential in preserving cell viability during cryopreservation.

 

  • Protein Stabilization:
    Trehalose dihydrate by Pfanstiehl is well known for stabilizing proteins during freezing and thawing. Proteins can become damaged or lose shape when exposed to low temperatures which can cause issues like denaturation and clumping. Trehalose works by forming a protective layer around proteins that keeps them stable and maintains their proper structure. This is particularly important in protein-based drugs like vaccines, where the protein’s structure is critical for its effectiveness.

 

  • Prevention of Freeze-Thaw Damage:
    Low endotoxin Trehalose is an effective cryoprotectant that reduces the harmful effects of freezing and thawing on biological materials. Freezing can cause ice crystals to form which damage cells and proteins. Trehalose prevents the formation of large ice crystals and minimizes damage. This is important for preserving biological samples and ensuring that cells and proteins remain intact and functional.

 

  • Improved Viability and Functionality:
    Trehalose improves the survival and function of cells and biological molecules after thawing. Freezing can damage cells and reduce their effectiveness but trehalose protects them and ensures they retain their function when thawed. This is especially valuable for vaccines, antibodies and other biopharmaceutical products where maintaining the activity of the molecules is essential for successful treatment.

 

  • Enhanced Long-Term Storage:
    Trehalose  helps store biological materials at very low temperatures for extended periods without losing their function. Long-term storage can cause biological products to degrade but Trehalose protects them from damage during freezing and dehydration. This is critical in the biotechnology and pharmaceutical industries where products must remain stable over time for use in treatments such as vaccines or gene therapies.

References/Citations:

Pfanstiehl Trehalose dihydrate Citation Page

References/Citations:

Pfanstiehl Trehalose dihydrate Citation Page

Selected Publications

Elder, Charles A., et al. “Cryopreserved red blood cells maintain allosteric control of oxygen binding when utilizing trehalose as a cryoprotectant.” Cryobiology, Volume 114, 2024,104793, ISSN 0011-2240

Zhang, Miao, et al. “Freeze-drying of mammalian cells using trehalose: preservation of DNA integrity.” Scientific reports 7.1 (2017): 6198

 

Highest cGMP Compendial Quality for Highest Risk Applications

 

Pfanstiehl Brand High Purity – Low Endotoxin – Low Metals

  • Trehalose Dihydrate

  • Trehalose Dihydrate (Low Glucose)

  • Trehalose Dihydrate Inhalation Grade

 

These products are specifically designed for biopharmaceutical formulation and commercial manufacturing.

 

They are produced in the United States under full ICH-Q7 cGMP conditions, ensuring the highest standards of quality and purity.

 

Compliant with NF (National Formulary) EP (European) JP (Japanese) and ChP (Chinese) Pharmacopoeia

 

Due to Pfanstiehl’s rigorous manufacturing specifications and robust Quality Systems, you can be confident that Pfanstiehl products consistently meet the highest standards of quality and reliability across every batch.

 

Engineered to be the safest and most dependable option for use in manufacturing or research applications.

Product Name:

Trehalose dihydrate (Plant derived)

Quality Level:

  • Highest – Parenteral Excipient Grade cGMP
  • Suitable for  Injectable Biologic & Vaccine Formulation
  • Suitable for Inhalation & Ophthalmic Formulation

Attributes:

  • Highest Purity
  • Lowest Endotoxin
  • Lowest Metals
  • Lowest Bioburden
  • Lowest Nitrosamines

Agency Pharmacopeia:

  • NF
  • EP
  • JP
  • ChP

Applications:

  • Parenteral Formulation
  • Ophthalmic Formulation
  • Inhalation Formulation
  • Cryopreservation
  • Lyophilization
  • Final Formulation

  • Product Name:

    Trehalose dihydrate (Plant derived)

  • Quality Level:

    • Highest – Parenteral Excipient Grade cGMP
    • Suitable for  Injectable Biologic & Vaccine Formulation
    • Suitable for Inhalation & Ophthalmic Formulation

  • Attributes:

    • Highest Purity
    • Lowest Endotoxin
    • Lowest Metals
    • Lowest Bioburden
    • Lowest Nitrosamines

  • Agency Pharmacopeia:

    • NF
    • EP
    • JP
    • ChP

  • Applications:

    • Parenteral Formulation
    • Ophthalmic Formulation
    • Inhalation Formulation
    • Cryopreservation
    • Lyophilization
    • Final Formulation
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