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Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity

Cappelletto, Elia ; Kwok, Stanley C. ; Sorret, Lea ; Fuentes, Nathalie ; Medina, Annette ; Burleigh, Stephen LU ; Fast, Jonas LU ; Mackenzie, Isla S. ; Fureby, Anna Millqvist LU and Paulsson, Mattias , et al. (2024) In Journal of Pharmaceutical Sciences
Abstract

This article evaluates the current gaps around the impact of post-manufacturing processes on the product qualities of protein-based biologics, with a focus on user centricity. It includes the evaluation of the regulatory guidance available, describes a collection of scientific literature and case studies to showcase the impact of post-manufacturing stresses on product and dosing solution quality. It also outlines the complexity of clinical handling and the need for communication, and alignment between drug providers, healthcare professionals, users, and patients. Regulatory agencies provide clear expectations for drug manufacturing processes, however, guidance supporting post-product manufacturing handling is less defined and often... (More)

This article evaluates the current gaps around the impact of post-manufacturing processes on the product qualities of protein-based biologics, with a focus on user centricity. It includes the evaluation of the regulatory guidance available, describes a collection of scientific literature and case studies to showcase the impact of post-manufacturing stresses on product and dosing solution quality. It also outlines the complexity of clinical handling and the need for communication, and alignment between drug providers, healthcare professionals, users, and patients. Regulatory agencies provide clear expectations for drug manufacturing processes, however, guidance supporting post-product manufacturing handling is less defined and often misaligned. This is problematic as the pharmaceutical products experience numerous stresses and processes which can potentially impact drug quality, safety and efficacy. This article aims to stimulate discussion amongst pharmaceutical developers, health care providers, device manufacturers, and public researchers to improve these processes. Patients and caregivers' awareness can be achieved by providing relevant educational material on pharmaceutical product handling.

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organization
publishing date
type
Contribution to journal
publication status
epub
subject
keywords
Antibody drug(s), Chemical stability, Degradation product(s), Photodegradation, Physical stability, Protein formulation(s)
in
Journal of Pharmaceutical Sciences
publisher
Elsevier
external identifiers
  • scopus:85195571077
  • pmid:38810881
  • pmid:38810881
ISSN
0022-3549
DOI
10.1016/j.xphs.2024.05.027
language
English
LU publication?
yes
id
dce2663d-ab07-4360-90d4-95d88351e250
date added to LUP
2024-06-04 07:49:01
date last changed
2024-06-18 10:53:58
@article{dce2663d-ab07-4360-90d4-95d88351e250,
  abstract     = {{<p>This article evaluates the current gaps around the impact of post-manufacturing processes on the product qualities of protein-based biologics, with a focus on user centricity. It includes the evaluation of the regulatory guidance available, describes a collection of scientific literature and case studies to showcase the impact of post-manufacturing stresses on product and dosing solution quality. It also outlines the complexity of clinical handling and the need for communication, and alignment between drug providers, healthcare professionals, users, and patients. Regulatory agencies provide clear expectations for drug manufacturing processes, however, guidance supporting post-product manufacturing handling is less defined and often misaligned. This is problematic as the pharmaceutical products experience numerous stresses and processes which can potentially impact drug quality, safety and efficacy. This article aims to stimulate discussion amongst pharmaceutical developers, health care providers, device manufacturers, and public researchers to improve these processes. Patients and caregivers' awareness can be achieved by providing relevant educational material on pharmaceutical product handling.</p>}},
  author       = {{Cappelletto, Elia and Kwok, Stanley C. and Sorret, Lea and Fuentes, Nathalie and Medina, Annette and Burleigh, Stephen and Fast, Jonas and Mackenzie, Isla S. and Fureby, Anna Millqvist and Paulsson, Mattias and Wahlgren, Marie and Elofsson, Ulla and Flynn, Angela and Miolo, Giorgia and Nyström, Lina and De Laureto, Patrizia Polverino and De Paoli, Giorgia}},
  issn         = {{0022-3549}},
  keywords     = {{Antibody drug(s); Chemical stability; Degradation product(s); Photodegradation; Physical stability; Protein formulation(s)}},
  language     = {{eng}},
  month        = {{05}},
  publisher    = {{Elsevier}},
  series       = {{Journal of Pharmaceutical Sciences}},
  title        = {{Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity}},
  url          = {{http://dx.doi.org/10.1016/j.xphs.2024.05.027}},
  doi          = {{10.1016/j.xphs.2024.05.027}},
  year         = {{2024}},
}