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Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

In drug development, the “onus” of the low R&D efficiency has been put traditionally onto the drug discovery process (i.e., finding the right target or “binding” functionality). Here, we show that manufacturing is not only a central component of product success, but also that, by integrating man...

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Autores principales: Zurdo, Jesús, Arnell, Andreas, Obrezanova, Olga, Smith, Noel, Gómez de la Cuesta, Ramón, Gallagher, Thomas R. A., Michael, Rebecca, Stallwood, Yvette, Ekblad, Caroline, Abrahmsén, Lars, Höidén-Guthenberg, Ingmarie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4449898/
https://www.ncbi.nlm.nih.gov/pubmed/26075248
http://dx.doi.org/10.1155/2015/605427
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author Zurdo, Jesús
Arnell, Andreas
Obrezanova, Olga
Smith, Noel
Gómez de la Cuesta, Ramón
Gallagher, Thomas R. A.
Michael, Rebecca
Stallwood, Yvette
Ekblad, Caroline
Abrahmsén, Lars
Höidén-Guthenberg, Ingmarie
author_facet Zurdo, Jesús
Arnell, Andreas
Obrezanova, Olga
Smith, Noel
Gómez de la Cuesta, Ramón
Gallagher, Thomas R. A.
Michael, Rebecca
Stallwood, Yvette
Ekblad, Caroline
Abrahmsén, Lars
Höidén-Guthenberg, Ingmarie
author_sort Zurdo, Jesús
collection PubMed
description In drug development, the “onus” of the low R&D efficiency has been put traditionally onto the drug discovery process (i.e., finding the right target or “binding” functionality). Here, we show that manufacturing is not only a central component of product success, but also that, by integrating manufacturing and discovery activities in a “holistic” interpretation of QbD methodologies, we could expect to increase the efficiency of the drug discovery process as a whole. In this new context, early risk assessment, using developability methodologies and computational methods in particular, can assist in reducing risks during development in a cost-effective way. We define specific areas of risk and how they can impact product quality in a broad sense, including essential aspects such as product efficacy and patient safety. Emerging industry practices around developability are introduced, including some specific examples of applications to biotherapeutics. Furthermore, we suggest some potential workflows to illustrate how developability strategies can be introduced in practical terms during early drug development in order to mitigate risks, reduce drug attrition and ultimately increase the robustness of the biopharmaceutical supply chain. Finally, we also discuss how the implementation of such methodologies could accelerate the access of new therapeutic treatments to patients in the clinic.
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spelling pubmed-44498982015-06-14 Early Implementation of QbD in Biopharmaceutical Development: A Practical Example Zurdo, Jesús Arnell, Andreas Obrezanova, Olga Smith, Noel Gómez de la Cuesta, Ramón Gallagher, Thomas R. A. Michael, Rebecca Stallwood, Yvette Ekblad, Caroline Abrahmsén, Lars Höidén-Guthenberg, Ingmarie Biomed Res Int Review Article In drug development, the “onus” of the low R&D efficiency has been put traditionally onto the drug discovery process (i.e., finding the right target or “binding” functionality). Here, we show that manufacturing is not only a central component of product success, but also that, by integrating manufacturing and discovery activities in a “holistic” interpretation of QbD methodologies, we could expect to increase the efficiency of the drug discovery process as a whole. In this new context, early risk assessment, using developability methodologies and computational methods in particular, can assist in reducing risks during development in a cost-effective way. We define specific areas of risk and how they can impact product quality in a broad sense, including essential aspects such as product efficacy and patient safety. Emerging industry practices around developability are introduced, including some specific examples of applications to biotherapeutics. Furthermore, we suggest some potential workflows to illustrate how developability strategies can be introduced in practical terms during early drug development in order to mitigate risks, reduce drug attrition and ultimately increase the robustness of the biopharmaceutical supply chain. Finally, we also discuss how the implementation of such methodologies could accelerate the access of new therapeutic treatments to patients in the clinic. Hindawi Publishing Corporation 2015 2015-05-17 /pmc/articles/PMC4449898/ /pubmed/26075248 http://dx.doi.org/10.1155/2015/605427 Text en Copyright © 2015 Jesús Zurdo et al. https://creativecommons.org/licenses/by/3.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Review Article
Zurdo, Jesús
Arnell, Andreas
Obrezanova, Olga
Smith, Noel
Gómez de la Cuesta, Ramón
Gallagher, Thomas R. A.
Michael, Rebecca
Stallwood, Yvette
Ekblad, Caroline
Abrahmsén, Lars
Höidén-Guthenberg, Ingmarie
Early Implementation of QbD in Biopharmaceutical Development: A Practical Example
title Early Implementation of QbD in Biopharmaceutical Development: A Practical Example
title_full Early Implementation of QbD in Biopharmaceutical Development: A Practical Example
title_fullStr Early Implementation of QbD in Biopharmaceutical Development: A Practical Example
title_full_unstemmed Early Implementation of QbD in Biopharmaceutical Development: A Practical Example
title_short Early Implementation of QbD in Biopharmaceutical Development: A Practical Example
title_sort early implementation of qbd in biopharmaceutical development: a practical example
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4449898/
https://www.ncbi.nlm.nih.gov/pubmed/26075248
http://dx.doi.org/10.1155/2015/605427
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