Process Scale Purification of Antibodies
暫譯: 抗體的製程規模純化

Gottschalk, Uwe

  • 出版商: Wiley
  • 出版日期: 2026-10-19
  • 售價: $8,770
  • 貴賓價: 9.5 折 $8,331
  • 語言: 英文
  • 頁數: 816
  • 裝訂: Hardcover - also called cloth, retail trade, or trade
  • ISBN: 1394278543
  • ISBN-13: 9781394278541
  • 相關分類: 化學 Chemistry、Machine Learning
  • 尚未上市,無法訂購

相關主題

商品描述

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 manufacturing
  • Updated guidance on protein A chromatography optimization and emerging alternatives for process-scale downstream operations in biopharmaceutical production
  • New chapters covering CMC considerations and regulatory requirements essential for successful antibody drug development and manufacturing approval
  • Practical approaches to raw material control and quality assurance that support robust and economical large-scale purification processes
  • Applications 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.

商品描述(中文翻譯)

運用專家策略解決抗體純化的下游瓶頸

單株抗體(monoclonal antibody)的銷售額已超過 3,000 億美元,而上游生產力的提升速度已超越下游產能,製造商正面臨迫切的純化瓶頸。《抗體的製程規模純化》(Process Scale Purification of Antibodies)現已推出第三版,匯集頂尖技術專家,致力於解決製程規模所面臨的挑戰。本書是一本深具權威性的參考資源,針對各項單元操作提供實務解決方案,同時持續更新內容,以符合生物製藥專業人員的需求。

本版更新了 protein A chromatography 的相關內容,新增 CMC 考量、原物料管制策略,並介紹 machine learning 與 AI 在純化製程中的應用。各章作者除了重新檢視傳統 chromatography,也提出在製程規模下處理抗體的創新方法。本書整合經驗證的流程與新興技術,協助業者因應日益增加的生產需求,同時不犧牲產品品質。

讀者還將獲得:

• 由領先專家提供的完整純化策略,針對抗體製造中各項單元操作的特定問題提出解決方案
• protein A chromatography 最佳化的最新指引,以及適用於生物製藥生產製程規模下游操作的新興替代方案
• 新增介紹 CMC 考量與法規要求的章節,這些內容對抗體藥物的成功開發、製造及取得核准至關重要
• 原物料管制與品質保證的實務方法,支援穩健且具經濟效益的大規模純化製程
• machine learning 與 artificial intelligence 在最佳化純化工作流程、提升下游操作製程效率方面的應用

製藥與生技科學家、生物製藥製程領域的化學工程師,以及產品開發或製程科學部門的專業人員,都會發現本書是不可或缺的資源。《抗體的製程規模純化》(Process Scale Purification of Antibodies)提供克服下游瓶頸並有效率地生產高純度治療性抗體所需的技術深度與實務指引。

作者簡介

UWE GOTTSCHALK, PhD, is an Operating Partner at Keensight Capital, a European growth buyout investor specializing in technology and healthcare. Over more than thirty years in biopharmaceutical manufacturing, he held senior positions at Lonza, Sartorius, and Bayer, building extensive expertise in downstream processing technologies and large-scale purification operations. His career spans the full spectrum of antibody production challenges, from process development through commercial manufacturing.

作者簡介(中文翻譯)

UWE GOTTSCHALK 博士是 Keensight Capital 的營運合夥人。Keensight Capital 是一家專注於科技與醫療保健領域的歐洲成長型收購投資機構。三十多年來,他一直從事生物製藥製造工作,曾在 Lonza、Sartorius 與 Bayer 擔任高階職務,累積了下游製程技術(downstream processing technologies)與大規模純化作業方面的豐富專業經驗。他的職涯涵蓋抗體生產所面臨的各項挑戰,從製程開發一直到商業化製造。