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Examination of the Protein Drug Supply Chain in a Swedish University Hospital: Focus on Handling Risks and Mitigation Measures
Uppsala University, Sweden; University of Barcelona, Spain.
AstraZeneca, UK.
University of Dundee, uk.
RISE Research Institutes of Sweden, Bioeconomy and Health, Chemical Process and Pharmaceutical Development.ORCID iD: 0000-0002-3350-0242
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2023 (English)In: Journal of Pharmaceutical Sciences, ISSN 0022-3549, E-ISSN 1520-6017Article in journal (Refereed) Epub ahead of print
Abstract [en]

Protein drugs, such as monoclonal antibodies, have proved successful in treating cancer and immune system diseases. The structural complexity of these molecules requires careful handling to ensure integrity and stability of the drug. In this study, a failure mode and effects analysis was performed based on a Gemba Walk method in a Swedish University Hospital. The Gemba Walk is focused on pharmacists observing the actual supply process steps from distributor, pharmacy cleanroom to patient administration. Relevant protein drugs are chosen based on sales statistics within the hospital and the corresponding wards were observed. Further is the Double Diamond design method used to identify major risks and deliver mitigation strategies. The study identified potential stress factors such as temperature, shock by impact, shaking, vibration and light exposure. There were also risks associated with porters’ and healthcare professionals’ lack of awareness and access to information. These risk factors may cause loss of efficacy and quality of the protein drug, potentially leading to patient safety concerns. In this study, a simulation is also performed to list measures that theoretically should be in place to ensure the quality of the protein drug, for example validated and protocol-based compounding in cleanroom, training and validated transports. © 2023 The Authors

Place, publisher, year, edition, pages
Elsevier B.V. , 2023.
Keywords [en]
Chemical stability, Immunotherapy, Injectables, Monoclonal antibodies, Protein aggregation, Stability, Transport
National Category
Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:ri:diva-65624DOI: 10.1016/j.xphs.2023.05.003Scopus ID: 2-s2.0-85162256505OAI: oai:DiVA.org:ri-65624DiVA, id: diva2:1777516
Note

This work has received support from the EU/EFPIA Innovative Medicines Initiative 2 Joint Undertaking (RealHOPE grant n° 101007939 ).

Available from: 2023-06-29 Created: 2023-06-29 Last updated: 2023-12-07Bibliographically approved

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Elofsson, UllaMillqvist-Fureby, Anna

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