生物制药
下游(制造业)
下游加工
过程(计算)
过程开发
资源(消歧)
计算机科学
工作流程
比例(比率)
机组运行
生化工程
工艺工程
产品(数学)
新产品开发
工程类
设计质量
制造工程
过程控制
原材料
最佳实践
上游(联网)
过程分析技术
制药工业
膨胀床吸附
渗滤
控制(管理)
生物技术
风险分析(工程)
工艺优化
出处
期刊:Wiley eBooks
[Wiley]
日期:2026-10-02
标识
DOI:10.1002/9781394278572
摘要
Solve downstream bottlenecks with expert strategies for antibody purification With monoclonal antibody sales exceeding $300 billion and upstream productivity outpacing downstream capacity, manufacturers face urgent purification bottlenecks. Process Scale Purification of Antibodies, now in its Third Edition, assembles top-tier technology experts to address process-scale challenges. This established resource delivers practical solutions for each unit operation while maintaining the currency that biopharmaceutical professionals require. This edition updates protein A chromatography coverage, adds CMC considerations, addresses raw material control strategies, and introduces machine learning and AI applications in purification processes. Contributors provide fresh perspectives on traditional chromatography alongside innovative methods for processing antibodies at scale. The book consolidates proven approaches with emerging technologies to meet increasing production demands without sacrificing product quality. Readers will also find: Comprehensive coverage of purification strategies from leading experts addressing problems specific to each unit operation in antibody manufacturingUpdated guidance on protein A chromatography optimization and emerging alternatives for process-scale downstream operations in biopharmaceutical productionNew chapters covering CMC considerations and regulatory requirements essential for successful antibody drug development and manufacturing approvalPractical approaches to raw material control and quality assurance that support robust and economical large-scale purification processesApplications of machine learning and artificial intelligence to optimize purification workflows and improve process efficiency in downstream operations Pharmaceutical and biotech scientists, chemical engineers in biopharmaceutical processing, and professionals in product development or process science departments will find this resource indispensable. Process Scale Purification of Antibodies delivers the technical depth and practical guidance needed to overcome downstream bottlenecks and deliver pure therapeutic antibodies efficiently.
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