Densifier® Extended Concentration Formulation Technology
Creative Biolabs is a professional vaccine research and development company that provides comprehensive CRO services. We are not only well versed in the design and preparation of various vaccines, but also have a series of related technologies to further improve the stability and efficacy of vaccines, as well as reduce the costs associated with vaccine development, production, transportation, vaccination and so on.
Background
Some drugs can only be effective at high doses. This feature not only causes inconvenience to patients but also increases patient expenditure. However, as the concentration of the drug in the formulation increases, the viscosity also increases, and thus the requirements for the syringe or pump are imposed. Although irreversible aggregation, precipitation, and high viscosity occur when the concentration is increased, in general, the protein has good solubility in an aqueous solution. Due to the volume contribution of the protein, 350 mg/mL is often the solubility limit of the protein in aqueous solution. Such high concentrations not only place high demands on the stability of the protein, but more importantly, its viscosity will also exceed the current production practices or the capacity to be used in parenteral administration methods. The demand for high-concentration formulations has led scientists to study a number of methods to increase drug concentration, such as optimizing the pH of the solution, using salts, and adding amino acids suitable for the target protein. However, these methods are often unsatisfactory, like limiting the effectiveness of the drug, only working for a small portion of the protein, and the concentration of the drug being increased being moderate.
Densifier® - Extended Concentration Formulation Technology
Previous studies have shown that the problems caused by high protein concentrations are mostly related to the interaction between molecules. These proteins have different charges, structures and hydrophobicities on the surface, and various interactions are formed on the surface. Therefore, one idea is to add free amino acids to the formula to interact with the surface sites of proteins with complementary characteristics and to mask the sites, hindering the formation of intermolecular interactions. One strategy that has been derived is the use of a combination of amino acids, which is more efficient because they can cover sites of different features on various protein surfaces, thereby inhibiting the formation of intermolecular interactions. Densifier® was developed based on the principle of using a combination of amino acids to stabilize and concentrate biopharmaceuticals. For each specific molecule, Densifier® will take into account the concentration, aggregation, injectability and stability of the formulation and optimize the amino acid combination. After drug injection, these amino acids will disperse and allow the drug to quickly enter the bloodstream.
Highlight Features of Densifier®
- Reduce viscosity greatly
- Significantly increase the concentration of a single dose of the drug
- No damage to drug molecules
- Safe, simple and stable
Creative Biolabs' superior Densifier® technology enhances the concentration of the vaccine which needs high-dose vaccination to guarantee efficacy while maintaining the stability of the vaccine. Densifier® is able to reduce viscosity resulting from high concentration significantly and allow drug molecules undamaged. If you are interested in this technology, please contact us.
All of our products can only be used for research purposes. These vaccine ingredients CANNOT be used directly on humans or animals.
