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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, Léa; Fuentes, Nathalie; Medina, Annette M; Burleigh, Stephen; Fast, Jonas; Mackenzie, Isla S; Fureby, Anna Millqvist; Paulsson, Mattias; Wahlgren, Marie; Elofsson, Ulla; Flynn, Angela; Miolo, Giorgia; Nyström, Lina; De Laureto, Patrizia Polverino; De Paoli, Giorgia.
Afiliação
  • Cappelletto E; Hospital Pharmacy, AULSS3 Serenissima, 30174 Mestre, Italy.
  • Kwok SC; Dosage Form Design and Development, BioPharmaceutical Development, R&D, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD 20878, USA.
  • Sorret L; Drug Product Services, Lonza AG, Hochbergerstrasse 60G, 4057 Basel, Switzerland.
  • Fuentes N; Dosage Form Design and Development, BioPharmaceutical Development, R&D, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD 20878, USA.
  • Medina AM; Dosage Form Design and Development, BioPharmaceutical Development, R&D, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD 20878, USA.
  • Burleigh S; Drug Product Services, Lonza AG, Hochbergerstrasse 60G, 4057 Basel, Switzerland; Department of Food Technology, Lund University, P.O. Box 124, 22100 Lund, Sweden.
  • Fast J; Pharmaceutical Development & Supplies, PTD, Biologics Europe, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland.
  • Mackenzie IS; MEMO Research, Division of Molecular and Clinical Medicine, University of Dundee, Dundee, United Kingdom.
  • Fureby AM; RISE Research Institutes of Sweden, Stockholm, Sweden.
  • Paulsson M; Department of Women's and Children's Health, Uppsala University, Akademiska sjukhuset, SE-751 85 Uppsala, Sweden.
  • Wahlgren M; RISE Research Institutes of Sweden, Stockholm, Sweden; Department of Food Technology, Lund University, P.O. Box 124, 22100 Lund, Sweden.
  • Elofsson U; RISE Research Institutes of Sweden, Stockholm, Sweden.
  • Flynn A; MEMO Research, Division of Molecular and Clinical Medicine, University of Dundee, Dundee, United Kingdom.
  • Miolo G; Department of Pharmaceutical and Pharmacological Sciences, University of Padova (UNIPD).
  • Nyström L; RISE Research Institutes of Sweden, Stockholm, Sweden.
  • De Laureto PP; Department of Pharmaceutical and Pharmacological Sciences, University of Padova (UNIPD).
  • De Paoli G; School of Health Sciences, University of Dundee, Dundee, United Kingdom. Electronic address: gdepaoli@dundee.ac.uk.
J Pharm Sci ; 113(8): 2055-2064, 2024 Aug.
Article em En | MEDLINE | ID: mdl-38810881
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos Idioma: En Ano de publicação: 2024 Tipo de documento: Article