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
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 on “BIOHALE® Sucrose” here
(click the picture to download the 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 on “BIOHALE® Trehalose Dihydrate” here
(click the picture to download the brochure)
![Biohale Trehalose Dihydrate]()
Source: DFE Pharma, brochure “BIOHALE® Trehalose Dihydrate”
See the full brochure on “BIOHALE®” here
(click the picture to download the brochure)
Source: DFE Pharma, brochure “BIOHALE®”