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Examination of the ...
Examination of the Protein Drug Supply Chain in a Swedish University Hospital : Focus on Handling Risks and Mitigation Measures
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- Martínez, Clàudia Sabaté (author)
- Uppsala universitet,Institutionen för kvinnors och barns hälsa,Faculty of Pharmacy and Food Science, University of Barcelona, Spain,Uppsala University Hospital,Uppsala University, Sweden; University of Barcelona, Spain
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- Amery, Leanne (author)
- AstraZeneca, UK
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- De Paoli, Giorgia (author)
- University of Dundee, uk
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- Elofsson, Ulla (author)
- RISE,Kemiska processer och läkemedel
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- Fureby, Anna Millqvist (author)
- RISE,Kemiska processer och läkemedel
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- Kwok, Stanley (author)
- AstraZeneca, USA
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- López-Cabezas, Carmen (author)
- Hospital Clínic of Barcelona,Hospital Clínic Barcelona, Spain
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- Rosenberger, Marika (author)
- Sanofi-Aventis Deutschland GmbH, Germany
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- Schoenau, Christian (author)
- Sanofi-Aventis Deutschland GmbH, Germany
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- Wahlgren, Marie (author)
- Lund University,Lunds universitet,Avdelningen för livsmedel och läkemedel,Institutionen för processteknik och tillämpad biovetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Division of Food and Pharma,Department of Process and Life Science Engineering,Departments at LTH,Faculty of Engineering, LTH,Lund University,Sweden
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- Paulsson, Mattias (author)
- Uppsala universitet,Barnonkologisk forskning - särskilt fokus på komplikationer,Uppsala University Hospital,Uppsala University, Sweden
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(creator_code:org_t)
- Elsevier, 2023
- 2023
- English 12 s.
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In: Journal of Pharmaceutical Sciences. - : Elsevier. - 0022-3549 .- 1520-6017. ; 112:11, s. 2799-2810
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Samhällsfarmaci och klinisk farmaci (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Social and Clinical Pharmacy (hsv//eng)
Keyword
- Chemical stability
- Immunotherapy
- Injectables
- Monoclonal antibodies
- Protein aggregation
- Stability
- Transport
- Chemical stability
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Martínez, Clàudi ...
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Amery, Leanne
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De Paoli, Giorgi ...
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Elofsson, Ulla
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Fureby, Anna Mil ...
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Kwok, Stanley
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López-Cabezas, C ...
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Rosenberger, Mar ...
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Schoenau, Christ ...
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Wahlgren, Marie
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Paulsson, Mattia ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Pharmaceutical S ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Social and Clini ...
- Articles in the publication
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Journal of Pharm ...
- By the university
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Lund University
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Uppsala University
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RISE