Biologics have changed the treatment of many high-burden causing diseases, like autoimmune conditions or different types of cancer; changing the lives of thousands of patients. Now well established in many therapeutic areas, they are entering non-traditional biologic disease areas, such as asthma, dyslipidemia, and allergies. Biologics offer distinct advantages over small molecules, however are far more complex to develop, manufacture and distribute.
Unlike taking medications orally or via inhalation, introducing a drug into the body by parenteral administration poses greater risk, since the body's natural defenses are bypassed. As such, they must be exceptionally pure and free from physical, chemical and biological contaminants. To meet these requirements, DFE Pharma offers a specific portfolio of excipients for biologics under the BioHale® brand, which guarantees high purity and low endotoxin levels.
Uncompromised quality with BioHale®
Our BioHale® portfolio, comprised by BioHale® Sucrose and BioHale® Trehalose Dihydrate, can be used in various administration forms, such as for parenteral, inhalation, oral or ophthalmic route. BioHale® enables the stabilization of biologics in biopharmaceutical formulations and among many other biologic treatments, BioHale® is already used in several of the current vaccines against COVID-19.
By making use of the best available technologies in state-of-the-art cGMP, FDA inspected manufacturing, BioHale® portfolio ensures highest purity of excipients low in endotoxin. Our excipients comply with the global regulatory requirements of the pharmaceutical industry (Ph. Eur., USP-NF, JP, ChP) and they are produced according to ICHQ7 guidelines.
Stability for Biologics, Security for Supply
The high and growing demand for biopharma formulations including COVID-19 vaccines, and the scarcity of production availability of crucial excipients, are among the key challenges that biopharmaceutical companies are currently facing.
To ensure customer security of supply, DFE Pharma is committed to supporting biopharmaceutical customers in the formulation of efficacious delivery of biologics. We offer solutions to overcome their challenges, ensuring a smooth supply of critical excipients (like Sucrose and Trehalose) enabling companies to comply with the high demand for biologics.
In our manufacturing facility in the Netherlands, we are applying a purification process that controls the level of purity and endotoxin and is therefore not restricted to raw material supply, production campaigns and there is no need for batch selection. DFE Pharma has local stocks and capacity available to ensure flawless supply today and in the future.
Technical solution provider
In addition to serving product and service excellence, DFE Pharma provides the full benefits of profound technical know-how and application knowledge for our customers. We are highly rated by our customers for our technical expertise and regulatory, quality and formulation support. With the combination of the right BioHale® excipients, we support you to create biological medicine allowing fast time-to-market for your products. Local regulatory support and Excipient Information Packaging will support swift qualification and implementation. Together we can create best solutions for your therapeutic actives in helping people live healthier lives.