1. Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity.
- Author
-
Cappelletto E, Kwok SC, Sorret L, Fuentes N, Medina AM, Burleigh S, Fast J, Mackenzie IS, Fureby AM, Paulsson M, Wahlgren M, Elofsson U, Flynn A, Miolo G, Nyström L, De Laureto PP, and De Paoli G
- Subjects
- Humans, Proteins chemistry, Quality Control, Drug Industry methods, Biological Products chemistry
- 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 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., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF