Determination of critical quality attributes for monoclonal antibodies using quality by design principles

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• 作者：Nadja Alt^a ; ^{nadja.alt@roche.com" class="auth_mail" title="E-mail the corresponding author} ; Taylor Y. Zhang^d ; Paul Motchnik^e ; Ron Taticek^d ; Valerie Quarmby^f ; Tilman Schlothauer^b ; Hermann Beck^c ; Thomas Emrich^b ; Reed J. Harris^d
• 关键词：Quality by design ; Critical quality attribute ; Risk ranking and filtering
• 刊名：Biologicals
• 出版年：2016
• 出版时间：September 2016
• 年：2016
• 卷：44
• 期：5
• 页码：291-305
• 全文大小：1016 K

文摘

Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11). An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody. This chapter describes the identification of critical quality attributes (CQAs) as an important first step for QbD development of biopharmaceuticals. A systematic scientific based risk ranking and filtering approach allows a thorough understanding of quality attributes and an assignment of criticality for their impact on drug safety and efficacy. To illustrate the application of the approach and tools, a few examples from monoclonal antibodies are shown. The identification of CQAs is a continuous process and will further drive the structure and function characterization of therapeutic proteins.