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

Elia Cappelletto, Stanley C. Kwok, Léa Sorret, Nathalie Fuentes, Annette M. Medina, Stephen Burleigh, Jonas Fast, Isla S. Mackenzie, Anna Millqvist Fureby, Mattias Paulsson, Marie Wahlgren, Ulla Elofsson, Angela Flynn, Giorgia Miolo, Lina Nyström, Patrizia Polverino De Laureto, Giorgia De Paoli*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

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.

Original languageEnglish
JournalJournal of Pharmaceutical Sciences
DOIs
Publication statusPublished - 27 May 2024

Keywords

  • Antibody drug(s)
  • Chemical stability
  • Degradation product(s)
  • Photodegradation
  • Physical stability
  • Protein formulation(s)

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