Petrides Demetri, Carmichael Doug, Siletti Charles, Koulouris Alexandros
Intelligen Inc., Scotch Plains, NJ 07076, USA.
Bioengineering (Basel). 2014 Sep 29;1(4):154-187. doi: 10.3390/bioengineering1040154.
Design and assessment activities associated with a biopharmaceutical process are performed at different levels of detail, based on the stage of development that the product is in. Preliminary "back-of-the envelope" assessments are performed early in the development lifecycle, whereas detailed design and evaluation are performed prior to the construction of a new facility. Both the preliminary and detailed design of integrated biopharmaceutical processes can be greatly assisted by the use of process simulators, discrete event simulators or finite capacity scheduling tools. This report describes the use of such tools for bioprocess development, design, and manufacturing. The report is divided into three sections. Section One provides introductory information and explains the purpose of bioprocess simulation. Section Two focuses on the detailed modeling of a single batch bioprocess that represents the manufacturing of a therapeutic monoclonal antibody (MAb). This type of analysis is typically performed by engineers engaged in the development and optimization of such processes. Section Three focuses on production planning and scheduling models for multiproduct plants.
与生物制药工艺相关的设计和评估活动，会根据产品所处的开发阶段，在不同的详细程度上进行。初步的“粗略估算”评估在开发生命周期的早期进行，而详细设计和评估则在新设施建设之前进行。使用过程模拟器、离散事件模拟器或有限产能调度工具，能够极大地辅助综合生物制药工艺的初步设计和详细设计。本报告描述了这些工具在生物工艺开发、设计和制造中的应用。报告分为三个部分。第一部分提供介绍性信息，并解释生物工艺模拟的目的。第二部分专注于单个批次生物工艺的详细建模，该工艺代表治疗性单克隆抗体（MAb）的生产。这类分析通常由从事此类工艺开发和优化的工程师进行。第三部分专注于多产品工厂的生产计划和调度模型。
