How does real-world handling affect protein drugs?
11 October 2021, 08:17
There is little research on real-world handling of protein drugs. Although it is well known that proteins may be affected by exposure to heat, sunlight or shaking, it is not known to what extent transportation and handling can cause an adverse effect on these specific types of drugs. RealHOPE aims to measure real-life events during drug handling to develop methods for simulating these events. The results of this project will aid the development of more robust protein drugs with increased safety profiles for patients. The project is coordinated by RISE and Lund University and is funded by the Innovative Medicines Initiative and EFPIA partners.
Innovative protein drugs have the potential to cure previously uncurable diseases and save lives. But they are sensitive due to their complex structure and require careful handling to preserve the activity. During production and delivery to pharmacies, optimal conditions, such as temperature, are ensured and carefully monitored. However, research on transportation and further handling in real life are minimal. For example, not knowing how drugs react to shaky transportation or being left on a sunny garden table by patients might lead to fully functional drugs being discarded or drugs that lack in efficiency being administered to the patient.
– Within RealHOPE, we have partners from the whole value-chain: including pharmaceutical companies, logistics companies, pharmacies, and a patient organization. In combination with instrument- and app developers, and academic researchers from different fields, we will have the possibility to acquire a deep understanding of the whole life-chain of a protein drug, from production to when it reaches the patient. I am very much looking forward to this collaboration, says Ulla Elofsson, Scientific coordinator at RISE.
RealHOPE will study real-life handling of protein drugs using smart tag technologies. Different parameters, such as light, temperature and shock, will be logged and combined with protein characterization at different stages, as well as with information from EFPIA partners on their drugs in use. Statistical evaluation of the data will be used to identify patterns in handling that are linked to protein destabilization occurrence and type of protein degradation.
The study will also include focus interviews with personnel in hospital pharmacies, clinics, patients and care givers to understand current handling practice and what the desired handling instructions and limitations are. These insights will be used to design in-use mimicking stability protocols for future development and new formulations of protein drugs. The collected data and interviews will form the basis for development of teaching materials directed towards different target groups: hospital pharmacists, nurses, patients, and care givers.
Ulla Elofsson, Scientific coordinator RISE
+46 76 684 00 40, firstname.lastname@example.org
About the Innovative Medicines Initiative
The Innovative Medicines Initiative (IMI) is a joint undertaking between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). It is working to improve health by speeding up the development of the next generation of medicines, particularly in areas where there is an unmet medical or social need.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101007939. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA companies.
RISE is Sweden’s research institute and innovation partner. Through our international collaboration programmes with industry, academia and the public sector, we ensure the competitiveness of the Swedish business community on an international level and contribute to a sustainable society. Our 2,800 employees engage in and support all types of innovation processes. RISE is an independent, State-owned research institute, which offers unique expertise and over 100 testbeds and demonstration environments for future-proof technologies, products and services.