In today’s competitive market, biologics manufacturers are under more pressure than ever to deliver to safe, effective therapies quickly -- all while maintaining rigorous quality standards. That’s why BioHale®, our trusted portfolio of high-purity stabilizers for biologics, combines best-in-class quality with the ease of local supply.

What Makes BioHale® Different?

  • Proven Quality

    Ultra-high purity, low endotoxin. BioHale® excipients are purpose-built for biologics—ensuring critical stability for your sensitive molecules.

    • Multi-compendial specifications compliant with USP-NF, JP, ChP monographs
    • Produced in state-of-the-art, FDA-inspected manufacturing facilities in accordance with ICH Q7, which provides cGMP guidance for the manufacturing of active pharmaceutical ingredients (APIs)

  • Secure Supply

    Consistent availability backed by DFE Pharma global supply chain expertise.

    • Active purification steps ensure excipients are independent of raw material variation.
    • Production capacity with full control of process ensures consistent quality, simplified qualification, and confidence where it matters most.

  • Faster, Simpler Ordering

    Comprehensive product documentation and unparalleled technical support available at your fingertips.

  • Trusted Speed

    Local stock from U.S. warehouses. Proven track record of delivery. Products ship within 5 to 7 days —reducing lead time so you can keep your project running on schedule. Order today. Formulate tomorrow.

With the increasing focus on innovation, BioHale® offers the peace of mind that comes with having a quick and convenient supply of high purity stabilizers. Together, we can build a healthier world.

The BioHale® Portfolio

Photo of BioHale® Trehalose Dihydrate, DFE Pharma's high purity, low endotoxin Trehalose Dihydrate.

BioHale® Trehalose Dihydrate USP-NF, EP, JP, ChP Low Endotoxin

BioHale® Trehalose Dihydrate is an ultra-high purity, low endotoxin excipient for the stabilization of drug, cosmeceutical and food and beverage formulations. BioHale Trehalose Dihydrate is well suited to provide solution-state stabilization, as well as cryo- and lyo-protection for biomolecules to use in parenteral, inhalation and ophthalmic applications.

Product data

Description
White, or almost white, crystals or crystalline powder
Molecular Formula
C12H22O11 · 2H2O
Molecular Weight
378.33 g/mol
Endotoxin
≤ 0.30 EU/g
Heavy Metals
≤ 5 ppm
Elemental Impurities
Complies with ICH Q3D
Total Impurities
≤ 0.5% (RRT<1.0)
Reducing Sugars
 ≤ 0.1%
CAS Number
6138-23-4
Tg
~107°C
Specifications
Multi-compendial specification complies with Ph. Eur., USP-NF, JP, ChP (Chinese DMF available)
Shelf Life
4 years
Packaging
1 kg (HDPE container) with PE inner liner,   20 kg (HDPE drum) with PE inner liner
Available Sizes
1kg, 20 kg
Application

Suitable for a wide variety parenteral, inhalation and ophthalmic administration routes. Commonly used for the lyoprotection and cryoprotection of therapeutic proteins, especially for parenteral administration. Other applications include use as stabilizing agent during the freeze–thaw and lyophilization of liposomes; and for stabilization of blood cells as well as monoclonal antibodies

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BioHale® Sucrose

BioHale® Sucrose (Beet-Derived) USP-NF, EP, JP, ChP Low Endotoxin

BioHale® Sucrose is a non-reducing crystalline disaccharide excipient made up of glucose and fructose. It is well suited to provide solution-state stabilization, as well as cryo and lyo-protection for biomolecules to be used in various administration forms, such as for parenteral or ophthalmic.

Product data

Description
White, or almost white, crystalline powder, or lustrous, colorless or white, or almost white, crystals
Source
Plant-derived, isolated from sugar beet
Molecular Formula
C12H22O11
Molecular Weight
342.30 g/mol
Endotoxin
≤ 0.25 EU/g
Heavy Metals
≤ 5 ppm
Elemental Impurities
Complies with ICH Q3D
Total Impurities
≤ 2.0%
Reducing Sugars
≤ 0.07%
CAS Number
57-50-1
Tg
~61°C
Specifications
Multi-compendial specification complies with Ph. Eur., USP-NF, JP, ChP
Packaging
20 kg (HDPE drum) with PE inner liner
Available Sizes
20 kg
Application

Commonly used in the pharmaceutical industry as a stabilizer, Sucrose can be also widely used as a cryopreservative and media supplement in a variety of cell-based bioprocesses. 

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BioHale® from DFE Pharma: Quality You Can Count On

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We’re confident that we develop, produce and supply the highest quality functional excipients – and we want you to discover that for yourself.  

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DFE Pharma’s team of technical and regulatory experts, regional sales, and customer service staff is committed to providing unwavering support and reliable guidance at every step of your formulation development and commercialization journey.

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