Exploring industry stakeholder perspectives on a clinical testbed for evaluating the handling of protein drugs in hospitals
Arvidsson, Jesper LU ; Alkhatib, Yaser ; Egen, Marc ; Elofsson, Ulla ; Millqvist, Anna Fureby LU ; López-Cabezas, Carmen ; Wahlgren, Marie LU
; Rosenberger, Marika
and Paulsson, Mattias
(2025)
In Journal of Pharmaceutical Sciences
114(4).
- 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... (More)
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.
(Less)
- author
- Arvidsson, Jesper
LU
; Alkhatib, Yaser
; Egen, Marc
; Elofsson, Ulla
; Millqvist, Anna Fureby
LU
; López-Cabezas, Carmen
; Wahlgren, Marie
LU
; Rosenberger, Marika
and Paulsson, Mattias
- organization
- publishing date
- 2025
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Injectables, Monoclonal antibody, Protein aggregation, Protein formulation, Stability, Transport
- in
- Journal of Pharmaceutical Sciences
- volume
- 114
- issue
- 4
- article number
- 103704
- pages
- 10 pages
- publisher
- Elsevier
- external identifiers
-
- pmid:39993712
- scopus:85219115413
- ISSN
- 0022-3549
- DOI
- 10.1016/j.xphs.2025.103704
- language
- English
- LU publication?
- yes
- additional info
- Publisher Copyright: © 2025 The Authors
- id
- 4ba2d077-3201-49f4-af42-112ff57a67fb
- date added to LUP
- 2025-03-16 14:26:51
- date last changed
- 2025-07-07 00:25:14
@article{4ba2d077-3201-49f4-af42-112ff57a67fb,
abstract = {{<p>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.</p>}},
author = {{Arvidsson, Jesper and Alkhatib, Yaser and Egen, Marc and Elofsson, Ulla and Millqvist, Anna Fureby and López-Cabezas, Carmen and Wahlgren, Marie and Rosenberger, Marika and Paulsson, Mattias}},
issn = {{0022-3549}},
keywords = {{Injectables; Monoclonal antibody; Protein aggregation; Protein formulation; Stability; Transport}},
language = {{eng}},
number = {{4}},
publisher = {{Elsevier}},
series = {{Journal of Pharmaceutical Sciences}},
title = {{Exploring industry stakeholder perspectives on a clinical testbed for evaluating the handling of protein drugs in hospitals}},
url = {{http://dx.doi.org/10.1016/j.xphs.2025.103704}},
doi = {{10.1016/j.xphs.2025.103704}},
volume = {{114}},
year = {{2025}},
}