Exploring industry stakeholder perspectives on a clinical testbed for evaluating the handling of protein drugs in hospitals

Abstract

Protein drugs, such as therapeutic antibodies, are complex and require careful handling to maintain their efficacy and quality. Stress factors in hospitals, like temperature variations and mechanical shocks during transport, may negatively impact the stability of protein drugs (e.g. various monoclonal antibodies). The pharmaceutical industry possesses extensive knowledge about their product formulations but often the transfer of knowledge from lab studies into in-hospital handling procedures is challenging. To address this gap and find a way to bridge academia, healthcare, and industry, seven semi-structured interviews were conducted with experts from pharmaceutical companies across five countries. This study aimed to explore the opinions of formulation experts regarding stress evaluation in clinical settings. Thematic analysis of the interviews revealed four key themes: The human factor in clinical sites, clinical sites as data providers, potential complexities in conducting tests within a clinical setting, and challenges associated with product-specific methods, equipment and devices. This study also suggests tools for setting up clinical test beds that can help the pharmaceutical industry improve stress evaluation and understand clinical product handling. Direct collaboration with clinical sites is crucial, as experts perceive improved evaluation methods and education to be necessary for ensuring safe medicines for patients.