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Impact of Post Manu...
Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity
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- Cappelletto, Elia (author)
- Venice-Mestre Hospital (Ospedale dell'Angelo),Hospital Pharmacy AULSS3 Serenissima, Italy
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- Kwok, Stanley C. (author)
- AstraZeneca, USA
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- Sorret, Lea (author)
- Lonza AG, Switzerland
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- Fuentes, Nathalie (author)
- AstraZeneca, USA
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- Medina, Annette (author)
- AstraZeneca, USA
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- Burleigh, Stephen (author)
- Lund University,Lunds universitet,Avdelningen för livsmedel och läkemedel,Institutionen för processteknik och tillämpad biovetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Division of Food and Pharma,Department of Process and Life Science Engineering,Departments at LTH,Faculty of Engineering, LTH,Lonza AG, Switzerland; Lund University, Sweden
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- Fast, Jonas (author)
- F Hoffmann-La Roche Ltd, Switzerland
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- Mackenzie, Isla S. (author)
- University of Dundee, UK
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- Fureby, Anna Millqvist (author)
- RISE,Kemiska processer och läkemedel
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- Paulsson, Mattias (author)
- Uppsala University,Uppsala University, Sweden
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- Wahlgren, Marie (author)
- RISE,Lund University,Lunds universitet,Avdelningen för livsmedel och läkemedel,Institutionen för processteknik och tillämpad biovetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,LTH profilområde: Teknik för hälsa,LTH profilområden,Division of Food and Pharma,Department of Process and Life Science Engineering,Departments at LTH,Faculty of Engineering, LTH,LTH Profile Area: Engineering Health,LTH Profile areas,Faculty of Engineering, LTH,Research Institutes of Sweden (RISE),Lund University, Sweden
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- Elofsson, Ulla (author)
- RISE,Kemiska processer och läkemedel
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- Flynn, Angela (author)
- University of Dundee, UK
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- Miolo, Giorgia (author)
- University of Padova, Italy
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- Nyström, Lina (author)
- RISE,Kemiska processer och läkemedel
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- De Laureto, Patrizia Polverino (author)
- University of Padova, Italy
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- De Paoli, Giorgia (author)
- University of Dundee, UK
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(creator_code:org_t)
- Elsevier B.V. 2024
- 2024
- English.
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In: Journal of Pharmaceutical Sciences. - : Elsevier B.V.. - 0022-3549 .- 1520-6017.
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http://dx.doi.org/10... (free)
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https://doi.org/10.1...
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https://ri.diva-port... (primary) (Raw object)
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
Subject headings
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- 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.
Subject headings
- TEKNIK OCH TEKNOLOGIER -- Maskinteknik -- Produktionsteknik, arbetsvetenskap och ergonomi (hsv//swe)
- ENGINEERING AND TECHNOLOGY -- Mechanical Engineering -- Production Engineering, Human Work Science and Ergonomics (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine (hsv//eng)
Keyword
- Antibody drug(s)
- Chemical stability
- Degradation product(s)
- Photodegradation
- Physical stability
- Protein formulation(s)
Publication and Content Type
- for (subject category)
- ref (subject category)
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- By the author/editor
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Cappelletto, Eli ...
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Kwok, Stanley C.
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Sorret, Lea
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Fuentes, Nathali ...
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Medina, Annette
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Burleigh, Stephe ...
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show more...
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Fast, Jonas
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Mackenzie, Isla ...
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Fureby, Anna Mil ...
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Paulsson, Mattia ...
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Wahlgren, Marie
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Elofsson, Ulla
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Flynn, Angela
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Miolo, Giorgia
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Nyström, Lina
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De Laureto, Patr ...
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De Paoli, Giorgi ...
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show less...
- About the subject
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- ENGINEERING AND TECHNOLOGY
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ENGINEERING AND ...
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and Mechanical Engin ...
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and Production Engin ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Pharmaceutical S ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
- Articles in the publication
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Journal of Pharm ...
- By the university
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Lund University
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RISE