Early Implementation of QbD in Biopharmaceutical Development: A Practical Example
Joint Authors
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
Source
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-19, 19 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-05-17
Country of Publication
Egypt
No. of Pages
19
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Zurdo, Jesús& Arnell, Andreas& Obrezanova, Olga& Smith, Noel& Gómez de la Cuesta, Ramón& Gallagher, Thomas R. A.…[et al.]. 2015. Early Implementation of QbD in Biopharmaceutical Development: A Practical Example. BioMed Research International،Vol. 2015, no. 2015, pp.1-19.
https://search.emarefa.net/detail/BIM-1056097
Modern Language Association (MLA)
Zurdo, Jesús…[et al.]. Early Implementation of QbD in Biopharmaceutical Development: A Practical Example. BioMed Research International No. 2015 (2015), pp.1-19.
https://search.emarefa.net/detail/BIM-1056097
American Medical Association (AMA)
Zurdo, Jesús& Arnell, Andreas& Obrezanova, Olga& Smith, Noel& Gómez de la Cuesta, Ramón& Gallagher, Thomas R. A.…[et al.]. Early Implementation of QbD in Biopharmaceutical Development: A Practical Example. BioMed Research International. 2015. Vol. 2015, no. 2015, pp.1-19.
https://search.emarefa.net/detail/BIM-1056097
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1056097