The new study, Exploring Industry Stakeholder Perspectives on a Clinical Testbed for Evaluating the Handling of Protein Drugs in Hospitals, has recently been published in the Journal of Pharmaceutical Science. The study highlights challenges in handling protein-based drugs in hospitals and suggests solutions, as a clinical testbed, to improve patient safety.
Protein-based drugs, such as therapeutic antibodies, are highly sensitive and must be handled carefully to maintain their effectiveness. Factors like temperature fluctuations and physical shocks during transport can negatively impact their stability. While the pharmaceutical industry has extensive knowledge of its products during manufacturing, storage, and shipping, there is limited understanding of how these drugs are managed in real-world hospital settings. Because hospitals have different procedures, equipment, and suppliers, it is difficult to address all aspects in drug development.
To explore this issue, the RealHOPE researcher Jesper Arvidsson conducted seven interviews with industry experts from five countries. The analysis identified four key challenges:
- The human factor – how hospital staff handling affects drug stability.
- Hospitals as data sources – the potential to collect real-world handling data.
- Practical barriers to hospital-based testing – challenges in conducting evaluations in clinical settings.
- Difficulties with product-specific tests and equipment – the need for tailored evaluation methods.
To bridge this knowledge gap, the study proposes the creation of a clinical testbed where academia, healthcare, and industry can collaborate to better understand handling challenges and improve stress evaluation for protein drugs. The study also presents practical tools for the testbed, including assessments of hospital equipment (e.g., pneumatic transport systems and preparation robots) as well as aspects of human infrastructure and medical devices (e.g., closed system transfer devices).
By improving evaluation methods and training, the pharmaceutical industry and healthcare sector can work together to ensure optimal handling of protein drugs – ultimately leading to safer treatments for patients.
Read the publication ⤵️
jpharmsci.org/article/S0022-3549(25)00140-6/fulltext
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