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Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity
Hospital Pharmacy AULSS3 Serenissima, Italy.
AstraZeneca, USA.
Lonza AG, Switzerland.
AstraZeneca, USA.
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2024 (English)In: Journal of Pharmaceutical Sciences, ISSN 0022-3549, E-ISSN 1520-6017Article in journal (Refereed) Epub ahead of print
Abstract [en]

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. 

Place, publisher, year, edition, pages
Elsevier B.V. , 2024.
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Basic Medicine
Identifiers
URN: urn:nbn:se:ri:diva-73771DOI: 10.1016/j.xphs.2024.05.027Scopus ID: 2-s2.0-85195571077OAI: oai:DiVA.org:ri-73771DiVA, id: diva2:1877257
Note

This project has received funding from the Innovative MedicinesInitiative 2 Joint Undertaking (JU) under grant agreement N°101007939 (RealHOPE). This Joint Undertaking receives support fromthe European Union’s Horizon 2020 research and innovation programme and EFPIA.

Available from: 2024-06-25 Created: 2024-06-25 Last updated: 2024-06-25Bibliographically approved

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Millqvist-Fureby, AnnaElofsson, UllaNyström, Lina

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