title: Early implementation of QbD in biopharmaceutical development: a practical example.
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.
authors.affiliation: Research and Technology, Pharma & Biotech, Lonza Biologics PLC, Granta Park, Great Abington, Cambridge CB21 6GS, UK.
authors.forename: Jesús
authors.initials: J
authors.lastname: Zurdo
authors.affiliation: Applied Protein Services, Lonza Biologics PLC, Granta Park, Great Abington, Cambridge CB21 6GS, UK.
authors.forename: Andreas
authors.initials: A
authors.lastname: Arnell
authors.affiliation: Applied Protein Services, Lonza Biologics PLC, Granta Park, Great Abington, Cambridge CB21 6GS, UK.
authors.forename: Olga
authors.initials: O
authors.lastname: Obrezanova
authors.affiliation: Applied Protein Services, Lonza Biologics PLC, Granta Park, Great Abington, Cambridge CB21 6GS, UK.
authors.forename: Noel
authors.initials: N
authors.lastname: Smith
authors.affiliation: Research and Technology, Pharma & Biotech, Lonza Biologics PLC, Granta Park, Great Abington, Cambridge CB21 6GS, UK.
authors.forename: Ramón
authors.initials: R
authors.lastname: Gómez de la Cuesta
authors.affiliation: Applied Protein Services, Lonza Biologics PLC, Granta Park, Great Abington, Cambridge CB21 6GS, UK.
authors.forename: Thomas R A
authors.initials: TR
authors.lastname: Gallagher
authors.affiliation: Applied Protein Services, Lonza Biologics PLC, Granta Park, Great Abington, Cambridge CB21 6GS, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Michael
authors.affiliation: Applied Protein Services, Lonza Biologics PLC, Granta Park, Great Abington, Cambridge CB21 6GS, UK.
authors.forename: Yvette
authors.initials: Y
authors.lastname: Stallwood
authors.affiliation: Affibody AB, Gunnar Asplunds Allé 24, 171 63 Solna, Sweden.
authors.forename: Caroline
authors.initials: C
authors.lastname: Ekblad
authors.affiliation: Affibody AB, Gunnar Asplunds Allé 24, 171 63 Solna, Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Abrahmsén
authors.affiliation: Affibody AB, Gunnar Asplunds Allé 24, 171 63 Solna, Sweden.
authors.forename: Ingmarie
authors.initials: I
authors.lastname: Höidén-Guthenberg
mesh_terms: D001702:Biopharmaceutics / Q000379:methods*; D015195:Drug Design; D004345:Drug Industry / Q000379:methods*; D006801:Humans