TY - JOUR
T1 - Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity
AU - Cappelletto, Elia
AU - Kwok, Stanley C.
AU - Sorret, Lea
AU - Fuentes, Nathalie
AU - Medina, Annette
AU - Burleigh, Stephen
AU - Fast, Jonas
AU - Mackenzie, Isla S.
AU - Fureby, Anna Millqvist
AU - Paulsson, Mattias
AU - Wahlgren, Marie
AU - Elofsson, Ulla
AU - Flynn, Angela
AU - Miolo, Giorgia
AU - Nyström, Lina
AU - De Laureto, Patrizia Polverino
AU - De Paoli, Giorgia
PY - 2024
Y1 - 2024
N2 - 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.
AB - 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.
KW - Antibody drug(s)
KW - Chemical stability
KW - Degradation product(s)
KW - Photodegradation
KW - Physical stability
KW - Protein formulation(s)
U2 - 10.1016/j.xphs.2024.05.027
DO - 10.1016/j.xphs.2024.05.027
M3 - Review article
C2 - 38810881
SN - 0022-3549
VL - 113
SP - 2055
EP - 2064
JO - Journal of Pharmaceutical Sciences
JF - Journal of Pharmaceutical Sciences
IS - 8
ER -