The efficacy and safety of therapeutic proteins can be severely compromised by their instability and the potential of protein misfolding and aggregation to elicit adverse immune responses upon administration to patients. Multiple factors have been suggested to cause these immune responses, but in several cases, they have been correlated with the presence of subvisible particulates composed of aggregated protein molecules. Protein aggregation may occur as a result of environmental changes and/or destabilizing conditions such as high temperature, high or low ionic strength, adsorption to container and delivery device surfaces, and mechanical agitation/shock. Despite well-controlled production and purification processes, protein particulates in therapeutic protein formulations may still arise from protein adsorption to the surfaces of containers such as vials, delivery pumps, and prefilled syringes, as well as the mechanical stresses resulting from these containers being agitated, dropped, or roughly handled.
Researchers at the University of Colorado have shown that hydrogel coatings are able to protect the protein formulation against mechanical stresses responsible for subsequent protein aggregation and particle formation. Hydrogels, three-dimensional hydrophilic polymeric networks, are capable of absorbing large amounts of water or biological fluids. Their unique properties such as high-water content, flexibility, biocompatibility and resemblance to living tissue opens up many opportunities for applications in biomedical areas.
- Reduced cavitation
- Increases robustness
- Reducing protein aggregation caused by mechanical stress and cavitation in:
- vaccine containers
- therapeutic protein containers
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