Artificial Intelligence in the Production of Biotherapeutics: Principles, Practices, and Standards
暫譯: 生物治療藥物生產中的人工智慧：原理、實務與標準
Srivastav, Alok Kumar, Das, Priyanka
- 出版商: CRC
- 出版日期: 2026-10-16
- 售價: $2,690
- 貴賓價: 9.5 折 $2,555
- 語言: 英文
- 頁數: 286
- 裝訂: Quality Paper - also called trade paper
- ISBN: 104103637X
- ISBN-13: 9781041036371
-
相關分類:
Machine Learning
尚未上市，無法訂購
相關主題
商品描述
The transformative role of artificial intelligence (AI) in modern biomanufacturing focuses on key areas such as process analytical technology (PAT), Good Manufacturing Practice (GMP) compliance, predictive analytics, and AI-driven quality systems. It bridges cutting-edge AI applications with the complexities of biotherapeutic production, offering insights into automation, real-time monitoring, and process optimization.
Delving into the core of biomanufacturing, the book provides a structured journey through its critical phases. It begins with an introduction to modern biomanufacturing principles, quality by design approaches, and the integration of AI. Subsequent chapters examine raw material management, lean manufacturing practices, and the application of predictive analytics to optimize supply chains. Readers will explore advanced tools such as AI-enhanced data acquisition in PAT, automated standard operating procedures (SOPs), and AI-driven process controls for fermenters and chromatography systems. The text also addresses GMP essentials, including personnel management, hygienic facility design, and pharmaceutical water systems. Key chapters highlight AI's role in validation processes, sterile packaging, and regulatory compliance, referencing global guidelines from organizations such as the WHO, FDA, and ICH. Real-world case studies featuring therapeutic proteins, monoclonal antibodies, and vaccines underscore the practical applications of AI in scaling and maintaining biotherapeutic production.
This book equips readers with a comprehensive understanding of AI's potential to enhance efficiency, accuracy, and compliance in biomanufacturing. Whether you are a professional, researcher, or student, this guide offers actionable insights into leveraging AI to revolutionize biotherapeutic production while adhering to the highest industry standards.
What You Will Learn:
- Understand how AI enhances every phase of biotherapeutic production, from raw material management to regulatory compliance, optimizing efficiency, accuracy, and quality
- Explore the role of AI in advanced data acquisition, process control, and continuous improvement, including applications in fermenters, flow filtration, and chromatography systems
- Gain insights into leveraging AI for automating standard operating procedures (SOPs), predictive maintenance, quality assurance, and adhering to global GMP standards like WHO and FDA guidelines
- Learn how AI transforms upstream and downstream processes, ensures sterility in packaging, and supports case studies on therapeutic proteins, monoclonal antibodies, and human vaccines
- Discover the potential of AI in shaping the future of biomanufacturing, including challenges, data security, and the ethical implications of AI-driven automation
商品描述(中文翻譯)
人工智慧（AI）在現代生物製造中的轉型作用，聚焦於製程分析技術（process analytical technology, PAT）、優良製造規範（Good Manufacturing Practice, GMP）合規性、預測分析，以及由 AI 驅動的品質系統等關鍵領域。本書將尖端 AI 應用與生物治療產品製造的複雜性相互連結，深入探討自動化、即時監控與製程最佳化。
本書深入探討生物製造的核心內容，並透過有系統的架構，引導讀者了解其中各個關鍵階段。內容首先介紹現代生物製造原則、設計導向品質（quality by design）方法，以及 AI 的整合。接續章節將探討原物料管理、精實製造實務，以及如何應用預測分析來最佳化供應鏈。讀者還將了解各種進階工具，例如 PAT 中經 AI 強化的資料擷取、自動化標準作業程序（standard operating procedures, SOPs），以及應用於發酵槽與層析系統的 AI 製程控制。
本書也涵蓋 GMP 的基本要點，包括人員管理、衛生設施設計與製藥用水系統。重要章節將說明 AI 在驗證流程、無菌包裝與法規合規中的作用，並參考 WHO、FDA 與 ICH 等組織發布的全球指引。書中以治療性蛋白質、單株抗體與疫苗為主題的真實案例研究，突顯 AI 在擴大生產規模及維持生物治療產品製造方面的實際應用。
本書將協助讀者全面了解 AI 提升生物製造效率、準確性與合規性的潛力。無論您是業界專業人士、研究人員或學生，本指南都能提供可實際應用的洞見，協助您運用 AI 徹底革新生物治療產品製造，同時遵循業界最高標準。
您將學到：
• 了解 AI 如何強化生物治療產品製造的每個階段，從原物料管理到法規合規，全面最佳化效率、準確性與品質
• 探索 AI 在進階資料擷取、製程控制與持續改善中的作用，包括其在發酵槽、切向流過濾（flow filtration）及層析系統中的應用
• 深入了解如何運用 AI 自動化標準作業程序（SOPs）、預測性維護與品質保證，並遵循 WHO 與 FDA 等全球 GMP 標準及指引
• 了解 AI 如何轉型上游與下游製程、確保包裝的無菌性，並支援以治療性蛋白質、單株抗體與人用疫苗為主題的案例研究
• 探索 AI 塑造生物製造未來的潛力，包括相關挑戰、資料安全，以及 AI 驅動自動化所涉及的倫理問題
作者簡介
Dr. Alok Kumar Srivastav is an accomplished Assistant Professor in the Department of Health Science at the University of the People, Pasadena, California, USA. His academic background includes a Ph.D., M.Tech, and M.Sc. in Bio-Technology, a Post-Doctoral Fellowship (Research) in Bio-Technology from Lincoln University College, Malaysia, and an MBA in Human Resource Management. He is a distinguished figure in Academia and Research, honored with the "International Pride of Educationist Award" at AIT, Thailand, in 2022 for pioneering contributions to advancing education in the digital era, and recipient of a prestigious "Innovative Academic Researcher Award" at HULT, France, UK, in 2024 for his exceptional creativity, innovation, and impact in academic research.
Dr. Priyanka Das serves as an Assistant Professor in the Department of Health Science at the University of the People in Pasadena, California, USA. She holds a Ph.D., M.Tech, and M.Sc. in Biotechnology along with an MBA in Human Resource Management. Prior to her current position, she was a Post-Doctoral Fellowship (Research) in Biotechnology at Lincoln University College, Malaysia. Dr. Priyanka Das is a dedicated scholar, contributing significantly to the field of Biotechnology.
作者簡介(中文翻譯)
Alok Kumar Srivastav 博士是美國加州帕薩迪納 University of the People 健康科學系的傑出助理教授。他擁有生物科技博士（Ph.D.）、生物科技技術碩士（M.Tech）及生物科技理學碩士（M.Sc.）學位，並曾於馬來西亞 Lincoln University College 擔任生物科技博士後研究員，另取得人力資源管理工商管理碩士（MBA）學位。他是學術與研究領域的傑出人士，於 2022 年在泰國 AIT 獲頒「International Pride of Educationist Award」，以表彰其在推動數位時代教育發展方面的先驅貢獻；2024 年，他於法國及英國的 HULT 獲頒享有盛譽的「Innovative Academic Researcher Award」，肯定其在學術研究方面展現的卓越創意、創新能力與影響力。
Priyanka Das 博士目前擔任美國加州帕薩迪納 University of the People 健康科學系的助理教授。她擁有生物科技博士（Ph.D.）、生物科技技術碩士（M.Tech）及生物科技理學碩士（M.Sc.）學位，並取得人力資源管理工商管理碩士（MBA）學位。在擔任現職之前，她曾於馬來西亞 Lincoln University College 從事生物科技博士後研究。Priyanka Das 博士是一位致力於學術研究的學者，對生物科技領域作出了重要貢獻。
