BIOHALE® – Products for the Stabilization of Biologics

High purity, low endotoxin excipients to stabilize biologics for use in parenteral, ophthalmic, or inhalation applications

BioHale® is  DFE Pharma´s, high-purity, low-endotoxin product portfolio for the stabilization of biologics. Because stability matters.

BioHale® Key promises:

  • Uncompromised quality
  • Security of supply
  • Expert support

Uncompromised quality

  • BioHale® high purity and low endotoxin excipients facilitate the stabilization of biomolecules, thereby reducing the loss of activity and efficacy in your medicines
  • Hassle free use and registration of excipients in all markets due to multi-compendial specification
  • Ensuring quality by producing in state-of-the-art manufacturing facilities, FDA inspected and in accordance with ICH Q7
  • DFE Pharma is a reliable and trusted supplier, known for our high-quality product standards with proven use in global leading Covid-19 vaccines

Specifications compliant with Ph. Eur., USP-NF, JP, ChP monographs


Security of Supply

  • Smooth supply of BioHale® excipients. Proven track record of delivering on time in full
  • Faster delivery of our BioHale® excipients due to local stocks in Europe, the US and Japan
  • BioHale® excipients are independent of raw material variation as the active purification steps ensure first time right quality
  • Production capacity available today and tomorrow

Full control of process

Full control of process
Full control of process

Expert support

  • We help to speed up your developments and lower pressure on R&D teams by providing the right technical expertise and formulation support
  • Swift and accurate qualification and registration due to availability of global and local quality and regulatory support

Excipient Information Package (EIP) and Self- Assessment Questionnaire (SAQ) available on request


Does your company need a predictable supply of high-purity excipients?

BioHale® Sucrose

  • With BioHale® Sucrose we offer the highest purity excipient for the stabilization of biologics to be used in biopharmaceutical formulation.
  • BioHale® Sucrose is a non-reducing crystalline disaccharide made up of glucose and fructose. 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.
  • Additionally, BioHale® Sucrose is preferred in applications where solubility or viscosity issues are of supreme importance.

See the full brochure onBIOHALE® Sucrosehere

(click the picture to download the brochure)

BioHale® Sucrose_brochure

Source: DFE Pharma, brochure “BIOHALE® Sucrose”

BioHale® Trehalose Dihydrate

  • With BioHale® Trehalose Dihydrate we offer the highest purity excipient for the stabilization of biologics to be used in biopharmaceutical formulation.
  • BioHale® Trehalose Dihydrate is a disaccharide formed by a 1,1 linkage of two d-glucose molecules.
  • It is a non-reducing sugar that is not easily hydrolyzed by acid, and the glycosidic bond is not cleaved by α-glucosidase.


See the full brochure onBIOHALE® Trehalose Dihydratehere

(click the picture to download the brochure)
Biohale Trehalose DihydrateSource: DFE Pharma, brochure “BIOHALE® Trehalose Dihydrate”


See the full brochure onBIOHALE®here

(click the picture to download the brochure)


Source: DFE Pharma, brochure “BIOHALE®”

Do you need more information or a sample of DFE Pharma excipients?

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