Aiming to propose best practices to hospitals and hospital pharmacies for handling of protein drugs.
RealHOPE consist of five work packages that each addresses the five project goals set for the project. The third work package is called HIGH and it will demonstrate and/or have develop new technologies for safer handling of protein drugs at hospital pharmacies. The project team will look at the methods and guidelines in use to improve the handling of drugs in hospital.
For many healthcare settings, where centralised preparation is not in available. HIGH will study the effects of manual preparation by nurses and compare to when automated compounding procedures are being used in hospital pharmacies. The protein integrity after handling in the different settings will be analysed.
In addition, an analytical instrument for analysis of physical changes in proteins (by UV, fluorescence and dynamic light scattering) will be adapted for use in a hospital pharmacy setting for easy and accurate quality assessment of prepared doses of protein drug products. The instrument data will be qualified towards parallel data sets obtained with specialised analytical instruments.
The producer of the instrument will be involved in the development, and in particular the user interface will be developed to suit the pharmacy environment. The optimised automated compounding procedures as well as the analytical instrument will be implemented in another hospital pharmacy (Barcelona) to evaluate how these can be transferred to another environment.
Collaboration with RealHOPE work packages GOLD, SHAPE and TEACH
The project team will have a special focus on compounding technology and rapid characterisation of prepared doses with respect to in particular protein aggregation and changes in protein structure.
HIGH will work closely with the work package GOLD regarding analytical methods. SHAPE and TEACH will collaborate with HIGH to gather the insights in operational procedures in different clinical environments, and how education on new technologies can be implemented for the automated compounding procedures and rapid quality assessment in the pharmacy.