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Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

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 :
BioMed Research International.
Publication Year :
2015
Publisher :
Hindawi Publishing Corporation, 2015.

Abstract

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.

Subjects

Subjects :
Article Subject

Details

Language :
English
ISSN :
23146133
Database :
OpenAIRE
Journal :
BioMed Research International
Accession number :
edsair.hindawi.publ..781b71be1ccc266f9f0ebbd3b34a2fba
Full Text :
https://doi.org/10.1155/2015/605427