Quality by design (QbD) is an innovative approach to drug development that has started to be implemented into the regulatory framework, but currently mainly for chemical drugs. The recent marketing authorization of the first monoclonal antibody developed using extensive QbD concepts in the European Union paves the way for future further regulatory approvals of complex products employing this cutting-edge technological concept. In this paper, we report and comment on insights and lessons learnt from the non-public discussions in the European Medicines Agency's Biologicals Working Party and Committee for Medicinal Products for Human Use on the key issues during evaluation related to the implementation of an extensive QbD approach for biotechnology-derived medicinal products. Sharing these insights could prove useful for future developments in QbD for biotech products in general and monoclonal antibodies in particular.

Implementing quality by design for biotech products: are regulators on track? / Luciani, F; Galluzzo, S; Gaggioli, A; Kruse, Na; Venneugues, P; Schneider, Ck; Pini, C; Melchiorri, Daniela. - In: MABS. - ISSN 1942-0862. - 7:3(2015), pp. 451-455. [10.1080/19420862.2015.1023058]

Implementing quality by design for biotech products: are regulators on track?

MELCHIORRI, Daniela
Ultimo
Writing – Original Draft Preparation
2015

Abstract

Quality by design (QbD) is an innovative approach to drug development that has started to be implemented into the regulatory framework, but currently mainly for chemical drugs. The recent marketing authorization of the first monoclonal antibody developed using extensive QbD concepts in the European Union paves the way for future further regulatory approvals of complex products employing this cutting-edge technological concept. In this paper, we report and comment on insights and lessons learnt from the non-public discussions in the European Medicines Agency's Biologicals Working Party and Committee for Medicinal Products for Human Use on the key issues during evaluation related to the implementation of an extensive QbD approach for biotechnology-derived medicinal products. Sharing these insights could prove useful for future developments in QbD for biotech products in general and monoclonal antibodies in particular.
2015
quality by design; monoclonal antibody; drug development; european medicines agency
01 Pubblicazione su rivista::01a Articolo in rivista
Implementing quality by design for biotech products: are regulators on track? / Luciani, F; Galluzzo, S; Gaggioli, A; Kruse, Na; Venneugues, P; Schneider, Ck; Pini, C; Melchiorri, Daniela. - In: MABS. - ISSN 1942-0862. - 7:3(2015), pp. 451-455. [10.1080/19420862.2015.1023058]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/781666
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