New biopharmaceutical formula using protein crystals in gels

Luis Álvarez de Cienfuegos

Universidad de Granada, Spain

Research

A new pharmaceutical formulation that involves the generation of protein crystals within an innocuous hydrogel formed by 99 % water. This process increases protein stability and facilitates the administration. Moreover, this new formulation will allow the health and pharmaceutical sectors to save money derived from the generation of more stable pharmaceutical drugs and promote patient quality of life as the drug would be administered in an easier way.

Aim

To extend this technology to different therapeutic proteins, and to bring the benefits of the new composites to every place by reducing the logistic required.

To provide a longer life-time of drugs than standard formulations which will allow the health and pharmaceutical sectors to save money derived from the removal and disposal of expired drugs.

To develop new formulations to improve the dosage and solve issues related to the route of administration without a loss of pharmacological activity, and therefore, minimize the related side-effects, this will mean a significant improvement in their quality of life.A new pharmaceutical formulation that involves the generation of protein crystals within an innocuous hydrogel formed by 99 % water. This process increases protein stability and facilitates the administration. Moreover, this new formulation will allow the health and pharmaceutical sectors to save money derived from the generation of more stable pharmaceutical drugs and promote patient quality of life as the drug would be administered in an easier way.

Problem to Solve

Thanks to advances in biotechnology, the number of therapeutic proteins used to treat various diseases has increased dramatically in recent years. However, the complex structure of proteins makes very difficult the stabilization and deliver of these compounds, limiting their therapeutic application.

We intend to give response to some of the unmet needs in the field of biopharmaceuticals by creating new formulations which tackle the pre-administration issues such as manufacturing, storage and transportation, increase the resistance to natural degradation and explore new ways of non-parenteral administration.

Innovation

This pharmaceutical formulation will consist of protein nanocrystals grown in a hydrogel comprising 0.1% of a biocompatible and biodegradable peptide and 99.9% water, without the need to add other additives. These hydrogels are designed to confer stability to the protein crystals and be administered subcutaneously by injection.

Level of Innovation

There are other delivering systems for biopharmaceuticals in the market using hydrogels as vehicles for drug delivery. However, this technology is completely novel and differs from others in the material of which hydrogels are made and the way how the protein is incorporated within hydrogel.

This difference offers key advantages as the number of manufacturing steps are reduced and the hydrogel have higher robustness and controlled release if compared to the other ones. A key innovation offered by this technology is in situ protein crystallization within peptide hydrogels, increasing the resistance of these crystals, being this unique. This feature offers to these hydrogel composites an ability to slow down the dissolution of the protein crystals which are embedded in the hydrogels.