Delivering on the Promise of Purity

Delivering on the Promise of PurityTM

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

Trehalose Dihydrate NF EP JP ChP

a, a Trehalose (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
  • Multi-Compendial Trehalose dihydrate
  • Suitable for Injectable Biologic, Vaccine, Inhalation, and Ophthalmic formulation

 

Trehalose dihydrate is a sugar made of two glucose units connected by a strong bond (α-1,1 bond), which makes it stable in acidic and high-temperature conditions. Unlike other sugars, it doesn’t undergo glycation because its structure 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 ability to resist breakdown make it useful in biological preservation, especially because of its cryoprotective properties.

 

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

 

Below the Tg, the molecules in the glassy state have limited movement, which reduces reactions that could harm the proteins, like aggregation or denaturation. This makes trehalose ideal for protecting sensitive biologics during freeze-drying (lyophilization) and storage, helping to maintain protein structure and function for therapeutic use.

 

Pfanstiehl Low Endotoxin Trehalose dihydrate 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 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 benefits include:

Cellular Protection:
Trehalose 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 structure of the cell. It also helps protect proteins and lipids inside the cells, preserving their function. This makes trehalose essential in preserving cell viability during processes like cryopreservation.

 

Protein Stabilization:
Trehalose dihydrate is well-known for stabilizing proteins during freezing and thawing. Proteins can become damaged or lose their shape when exposed to low temperatures, leading to problems like denaturation and clumping. Trehalose helps by forming a protective layer around proteins, keeping them stable and maintaining their proper structure. This is especially important in protein-based drugs, like vaccines, where the structure of the protein is crucial for its effectiveness.

 

Prevention of Freeze-Thaw Damage:
Purified, low endotoxin trehalose dihydrate is an effective cryoprotectant, reducing the harmful effects of freezing and thawing on biological materials. Freezing can cause ice crystals to form, which damage cells and proteins. Trehalose helps by preventing the formation of large ice crystals, minimizing damage. This is important in preserving biological samples, ensuring that the cells and proteins remain intact and functional.

 

Improved Viability and Functionality:
Trehalose dihydrate improves the survival and function of cells and biological molecules after thawing. Freezing can damage cells and reduce their effectiveness, but trehalose protects them, ensuring they retain their function when thawed. This is particularly 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 dihydrate is helpful for storing biological materials at very low temperatures for long 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 crucial in the biotechnology and pharmaceutical industries, where products need to remain stable over time for use in treatments, such as vaccines or gene therapies.

References/Citations:

Pfanstiehl Trehalose dihydrate Excipient GMP 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

 

 

Highest cGMP Compendial Quality for your Highest Risk Applications

 

Pfanstiehl Brand High Purity – Low Endotoxin – Low Metals

  • Trehalose Dihydrate,

  • Trehalose Dihydrate (Low Glucose)

  • Trehalose Dihydrate Inhalation Grade

 

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 Multi-Compendial 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.

Product Name:

Trehalose dihydrate (Plant derived)

Quality Level:

Highest – Parenteral Excipient Grade GMP

 

Multi-Compendial Trehalose dihydrate

Attributes:

Highest Purity

Lowest Endotoxin

Lowest Metals

Lowest Bioburden

Lowest Nitrosamines

Agency Pharmacopeia:

NF

EP

JP

ChP

Applications:

Parenteral Formulation

Ophthalmic Formulation

Inhalation Formulation ( Trehalose Inhalation Grade)

Liquid Formulation

Pharmaceutical Process

Biopharma Process

Cryopreservation

Lyophilization

Final Formulation

  • Product Name:

    Trehalose dihydrate (Plant derived)

  • Quality Level:

    Highest – Parenteral Excipient Grade GMP

     

    Multi-Compendial Trehalose dihydrate

  • Attributes:

    Highest Purity

    Lowest Endotoxin

    Lowest Metals

    Lowest Bioburden

    Lowest Nitrosamines

  • Agency Pharmacopeia:

    NF

    EP

    JP

    ChP

  • Applications:

    Parenteral Formulation

    Ophthalmic Formulation

    Inhalation Formulation ( Trehalose Inhalation Grade)

    Liquid Formulation

    Pharmaceutical Process

    Biopharma Process

    Cryopreservation

    Lyophilization

    Final Formulation

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Available Package Sizes:

100g, 1kg, 5kg, 10kg, 25kg, and 50kg

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