Examination of the protein drug supply chain in a Swedish university hospital: Focus on handling risks and mitigation measures

Clàudia Sabaté Martínez, Leanne Amery, Giorgia De Paoli, Ulla Elofsson, Anna Millqvist Fureby, Stanley Kwok, Carmen López-Cabezas, Marika Rosenberger, Christian Schoenau, Marie Wahlgren, Mattias Paulsson (Lead / Corresponding author)

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)
23 Downloads (Pure)

Abstract

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.

Original languageEnglish
Pages (from-to)2799-2810
Number of pages12
JournalJournal of Pharmaceutical Sciences
Volume112
Issue number11
Early online date7 May 2023
DOIs
Publication statusPublished - Nov 2023

Keywords

  • Protein aggregation
  • Chemical stability
  • Immunotherapy
  • Monoclonal antibodies
  • Injectables
  • Stability
  • Transport

ASJC Scopus subject areas

  • Pharmaceutical Science

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