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 (MAb). This chapter describes the tools used for the characterization and validation of MAb manufacturing process under the QbD paradigm. This comprises risk assessments for the identification of potential Critical Process Parameters (pCPPs), statistically designed experimental studies as well as studies assessing the linkage of the unit operations. Outcome of the studies is the classification of process parameters according to their criticality and the definition of appropriate acceptable ranges of operation. The process and product knowledge gained in these studies can lead to the approval of a Design Space. Additionally, the information gained in these studies are used to define the 'impact' which the manufacturing process can have on the variability of the CQAs, which is used to define the testing and monitoring strategy.

Christian Hakemeyer

Nathan McKnight

Rick St John

Steven Meier

Melody Trexler-Schmidt

Brian Kelley

Frank Zettl

Robert Puskeiler

Annika Kleinjans

Fred Lim

Christine Wurth

Biologicals : journal of the International Association of Biological Standardization

BIOLOGICALS 为人类和兽医学中使用的生物制品各个方面的新闻、辩论和原创研究提供了一个现代和多学科的国际论坛。该杂志发表与源自新颖和成熟生物技术的生物的开发、生产、质量控制和标准化相关的原始论文、评论和信件。制作特刊以反映国际上特别感兴趣和关注的主题。欢迎三种类型的论文：原创研究报告、短论文和评论文章。该杂志还将发表评论和致编辑的信件、书评、会议报告和监管问题信息。

Biologicals is a modern international forum that covers all aspects of biological products used in human and veterinary medicine, including news, debates, and original research. The journal publishes original papers, reviews, and letters related to the development, production, quality control, and standardization of biologics derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular interest and concern internationally. We welcome three types of submissions: original research articles, short papers, and review articles. The journal also includes commentaries, letters to the editor, book reviews, conference reports, and information on regulatory issues.

《Biologicals》是一个现代化的国际论坛，涵盖人类和兽医学中使用的生物制品的各个方面，包括新闻、辩论和原创研究。该杂志发表与新兴和成熟生物技术相关的生物的开发、生产、质量控制和标准化的原创论文、评论和信件。我们还会制作特刊，反映国际上特别感兴趣和关注的主题。欢迎提交三种类型的论文：原创研究报告、短论文和评论文章。此外，杂志还会刊登评论、致编辑的信件、书评、会议报告以及监管问题的信息。

Biologicals

Process characterization and Design Space definition.

This chapter describes the tools used for the characterization and validation of MAb manufacturing process under the QbD paradigm, which comprises risk assessments for the identification of potential Critical Process Parameters (pCPPs), statistically designed experimental studies as well as studies assessing the linkage of the unit operations.

Category	Quartile
生物学	4
生物学, 生化研究方法	4
生物学, 生物工程与应用微生物	4
生物学, 药学	4

Process characterization and Design Space definition.

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Journal Info

Category	Quartile
PHARMACOLOGY & PHARMACY	3