The sensitive structure of proteins makes the handling of protein drugs complex. With the right knowledge RealHOPE aim to change that.

The RealHOPE projects first work package is called SHAPE and addresses the project objective that states that the RealHOPE project have gained improved understanding of real-life handling of protein drugs. In order to reach the goal the project team within SHAPE is aiming to shape the initial part of the RealHOPE project by generating, collecting, and analysing qualitative and quantitative data in real-world scenarios.

Scientific literature studies and interviews

In the first part of SHAPE, information on the stress that protein drugs are subjected to when released from the manufacturer will be collected by analysing information from literature and other sources (grey literature and websites).

SHAPE will then work synergistically with the work package TEACH gathering qualitative information from the stakeholders involved in the post-release handling of protein drugs to address barriers, challenges, and successes when handling the products.

These data will support the work packages SHAPE, GOLD and TEACH development of educational guidelines to disseminate among the stakeholders.

Transport studies

The second part of the activities carried out in SHAPE will evaluate the main stresses that protein drugs are subjected to from a quantitative point of view.

SMEs, EFPIA partners, healthcare premises, academia and research institutes will strictly collaborate to investigate real or simulated handling (transportation, storage, supply, preparation, and use) scenarios.

Two different transport studies will be mirrored with laboratory simulations in GOLD. The data generated, collected, and analysed will influence the analysis processes that will be performed in GOLD.

Collaboration with Trials@Home (another IMI project) and other external stakeholders will be sought to create multiple opportunities to gather information and understand the stress that protein drugs are subjected to in different real-world scenarios.