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Real World Handling of Protein Drugs - Exploration, Evaluation and Education

Periodic Reporting for period 1 - RealHOPE (Real World Handling of Protein Drugs - Exploration, Evaluation and Education)

Reporting period: 2021-07-01 to 2022-06-30

During the last 20 years the number of protein drugs has increased substantially and have dramatically improved the lives of people with a range of diseases. However, ensuring the quality of protein drug products, particularly after manufacture, is far from easy. One drawback with these drugs is that their chemical and physical stability is considerably more complex than for small molecules. There are many things that can affect and compromise the safety and efficacy of the product. For example, handling of the proteins such as pumping of solutions (shear), interaction with primary packing material (adsorption) and temperature fluctuation are detrimental to product quality. Therefore, considerable effort has been made to identify triggers that reduce product quality for example during production. However, only a few studies have focused on the effects of handling drug products in hospitals and by patients. Inappropriately handled protein drugs may lead to adverse effects, such as immunological reactions due to aggregation, and a need to discard prepared medications due to unintentional mishandling (if noticed) or e.g. visual aggregation. This leads to unnecessary patient suffering and increased cost for health care and medication.
The overall objective of RealHOPE is to aid the development of more robust protein drugs with increased safety profiles for patients. RealHOPE 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.We will develop concrete and practical recommendations and tools for simulation of real-life events, mitigation of critical handling steps, and education to ensure careful handling by healthcare and pharmacy staff as well as patients.
The RealHOPE project has performed a literature review and stakeholder interviews to better understand the issues regarding handling of protein drugs by patients and professionals in the real world. This work will lead to publications and will inform analytical studies to better understand the impact of stressors encountered by protein drugs during their handling, and the production of educational packages to help improve the handling of protein drugs in future. Preliminary results have been published in a poster (G. de Paoli et al. Poster at DIA (Drug Information Association) meeting in Brussels, Belgium March 29-31, 2022).
RealHOPE aim to simulate real-life events. The stability of the monoclonal antibody Ipilimumab, used for the treatment of different types of cancer, has been investigated. Shaking/temperature, light exposure and dilution, protein drug renowned stressors, were applied on a 30–45-day series of experiments to observe the physicochemical and biological behaviour of the molecule. The results have been published in a paper (B. Fongaro et al., European Journal of Pharmaceutics and Biopharmaceutics, Volume 176, July 2022, Pages 54-74.).
Stakeholder interviews has also been performed to better understand the educational need by patients and professionals in the real-world handling of drugs. This work will lead to the development of educational material to help improve the handling of protein drugs in future.
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 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, as well as methods suited for simulation of real-world handling by patients, and handling in hospital pharmacy setting, respectively.