Advancing continuous biomanufacturing of monoclonal antibodies using an experimentally validated modeling platform
使用经过实验验证的建模平台推进单克隆抗体的连续生物制造
基本信息
- 批准号:10709083
- 负责人:
- 金额:$ 52.96万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-09-01 至 2027-08-31
- 项目状态:未结题
- 来源:
- 关键词:
项目摘要
Project Summary
Due to increased demand for biologics, there is an ongoing need to scientifically and commercially advance
manufacturing in both upstream cell culture and downstream purification steps. Our goal is to provide an
experimental infrastructure complemented by a computational framework to investigate the continuous
manufacturing of monoclonal antibodies (mAbs). The modeling approach will be based and validated using
specific experimental evidence to enhance our process understanding and improve model performance and
utilization during the design phase. The proposed innovations stem from the following objectives that will be
delivered as the outcome of this project, namely, 1) To develop a multiscale model for perfusion bioreactor
capturing the effects of operating parameters and cell line characteristics on critical quality attributes (CQAs)
validated by experimental results; 2) To develop methods for optimizing continuous chromatographic operations,
including primary capture and polishing steps, under a range of process conditions for optimal clearance of
process- and product-related impurities; and 3) To develop predictive models that will enable determination of
optimal operating conditions with direct coupling of upstream and downstream units accounting for product
quality attributes.
To enable process control, which is the ultimate target of advanced manufacturing, we will explore the design
space and identify the relationships between critical process parameters (CPPs), critical material attributes
(CMAs), and targeted CQAs. We will develop predictive models for all the important unit operations, validated
by experiments, that can be used to determine the design space along with statistical analysis of experimental
data to identify all critical parameters/attributes. The validated models will then be used as a virtual tool to perform
risk assessment for in-plant downstream operations such as scale-up/start-up/shutdown and compare process
operating scenarios. In terms of combining the developed strategies, we envision the integration with a
continuous upstream facility to achieve a fully automated continuous biomanufacturing line exploring and
optimizing the process interactions. This proof-of-concept line will be used to clearly quantify risk and
performance-based metrics.
项目摘要
由于对生物制剂的需求增加,因此需要在科学和商业上不断推进
在上游细胞培养和下游纯化步骤中进行生产。我们的目标是提供一个
实验基础设施,辅以计算框架,以调查连续
制造单克隆抗体(mAb)。建模方法将基于并验证使用
具体的实验证据,以加强我们的过程理解和提高模型的性能,
在设计阶段使用。拟议的创新源于以下目标,
作为本项目的成果,即:1)建立了灌注生物反应器的多尺度模型
捕获操作参数和细胞系特性对关键质量属性(CQA)的影响
通过实验结果验证; 2)开发优化连续色谱操作的方法,
包括初级捕获和抛光步骤,在一系列工艺条件下,
工艺和产品相关杂质;以及3)开发预测模型,
考虑产品的上下游单元直接耦合的最佳操作条件
质量属性。
为了实现过程控制,这是先进制造的最终目标,我们将探索设计
确定关键工艺参数(CPP)、关键物料属性
(CMA)和目标CQA。我们将为所有重要的单元操作开发预测模型,
通过实验,可以用来确定设计空间,沿着用统计分析实验
用于识别所有关键参数/属性的数据。然后,验证的模型将用作虚拟工具,
工厂内下游操作的风险评估,如放大/启动/关闭和比较工艺
操作场景。在结合制定的战略方面,我们设想与一个
连续上游设施,以实现全自动连续生物制造线探索和
优化过程交互。这一概念验证线将用于明确量化风险,
基于性能的指标。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Marianthi Ierapetritou其他文献
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{{ truncateString('Marianthi Ierapetritou', 18)}}的其他基金
Advancing continuous biomanufacturing of monoclonal antibodies using an experimentally validated modeling platform
使用经过实验验证的建模平台推进单克隆抗体的连续生物制造
- 批准号:
10681327 - 财政年份:2022
- 资助金额:
$ 52.96万 - 项目类别:
Advancing continuous biomanufacturing of monoclonal antibodies using an experimentally validated modeling platform
使用经过实验验证的建模平台推进单克隆抗体的连续生物制造
- 批准号:
10601587 - 财政年份:2022
- 资助金额:
$ 52.96万 - 项目类别:
Advanced continuous upstream manufacturing of biotherapeutics
先进的生物治疗上游连续制造
- 批准号:
10225085 - 财政年份:2020
- 资助金额:
$ 52.96万 - 项目类别:
Industry 4.0 Implementation in Continuous Pharmaceutical Manufacturing
工业 4.0 在连续制药制造中的实施
- 批准号:
10230736 - 财政年份:2020
- 资助金额:
$ 52.96万 - 项目类别:
Advanced continuous upstream manufacturing of biotherapeutics
先进的生物治疗上游连续制造
- 批准号:
10001353 - 财政年份:2020
- 资助金额:
$ 52.96万 - 项目类别:
Industry 4.0 Implementation in Continuous Pharmaceutical Manufacturing
工业 4.0 在连续制药制造中的实施
- 批准号:
10242738 - 财政年份:2020
- 资助金额:
$ 52.96万 - 项目类别:
Advanced continuous upstream manufacturing of biotherapeutics
先进的生物治疗上游连续制造
- 批准号:
9731975 - 财政年份:2018
- 资助金额:
$ 52.96万 - 项目类别:
Flowsheet Modeling and Analysis Tools for Solid Base Pharmaceutical Products Manufacturing
固体基础药品制造的流程建模和分析工具
- 批准号:
9124606 - 财政年份:2014
- 资助金额:
$ 52.96万 - 项目类别:
Flowsheet Modeling and Analysis Tools for Solid Base Pharmaceutical Products Manufacturing
固体基础药品制造的流程建模和分析工具
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8886572 - 财政年份:2014
- 资助金额:
$ 52.96万 - 项目类别:
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