Process Analytical Technology and Data Analysis for the Manufacturing of Biologics
暫譯: 生物製藥製造的過程分析技術與數據分析

本書介紹了生物製造品質要求的過程分析技術（Process Analytical Technologies, PAT）。內容涵蓋設計品質（quality by design）、過程監控、數據管理、實時追蹤、多變量分析以及機器學習演算法。書中包含案例研究和範例，適合學生、PAT 實務工作者及監管官員閱讀。

Prof. Amine Kamen holds the Canada Research Chair in Bioprocessing of Viral Vaccines at McGill University (retired) and is Researcher Emeritus at the National Research Council of Canada. He is a leading expert in bioprocess engineering, specializing in the development and manufacturing of viral vectors for vaccination and gene and cell therapy. His research has significantly advanced scalable production platforms for adenovirus, lentiviral, adeno-associated virus (AAV), and vesicular stomatitis viral (VSV) vectors, with applications in vaccine, CAR-T cell therapy, and gene editing development. His contributions include the development of serum-free suspension cultures using HEK-293SF and VERO cells, enabling high-yield production of clinical-grade viral vectors. Professor Kamen's work integrates cell culture engineering, process analytical technologies, and quality by design principles to ensure robust and reproducible manufacturing processes. Currently his efforts are directed to advancing mRNA technology for intensification and densification of cost-effective manufacturing processes to enable equitable access. He has authored over 210 peer-reviewed publications and has been instrumental in training the next generation of biomanufacturing professionals through academic and industry collaborations.
Dr. Rupa Haldavnekar is an assistant professor at the University of Oklahoma, School of Electrical and Computer Engineering. She holds a PhD in Biomedical Engineering with focus on surface-enhanced Raman scattering (SERS)-based molecular analysis for cancer diagnosis. Currently Dr. Haldavnekar is developing Raman spectroscopy-based process analytical technology for cancer diagnosis. Her research interests also include the development of orthogonal methods for the investigation of cellular interactions in tumor microenvironment.
Dr. Mario A. Jardon is Faculty Lecturer at the Department of Bioengineering, McGill University. He holds a PhD degree in Chemical and Biological Engineering. He has several years of experience in biopharmaceutical manufacturing. His scientific expertise includes the development and intensification of mammalian cell-based process for recombinant protein production, with a focus on integrating cellular stress responses and metabolism to understand and engineer biological systems responses, with the aim of developing high-performance manufacturing processes used for therapeutic biologics.

阿敏·卡門教授擔任麥吉爾大學（已退休）病毒疫苗生物處理的加拿大研究主席，並且是加拿大國家研究委員會的榮譽研究員。他是生物處理工程的領先專家，專注於疫苗和基因及細胞治療的病毒載體的開發和製造。他的研究顯著推進了腺病毒、慢病毒、腺相關病毒（AAV）和囊泡性口炎病毒（VSV）載體的可擴展生產平台，應用於疫苗、CAR-T細胞治療和基因編輯的開發。他的貢獻包括使用HEK-293SF和VERO細胞開發無血清懸浮培養，實現臨床級病毒載體的高產量生產。卡門教授的工作整合了細胞培養工程、過程分析技術和設計質量原則，以確保穩健且可重複的製造過程。目前，他的努力集中於推進mRNA技術，以強化和密集化具成本效益的製造過程，從而實現公平的獲取。他已發表超過210篇經過同行評審的出版物，並在學術和產業合作中對培養下一代生物製造專業人才發揮了重要作用。
魯帕·哈爾達夫尼卡博士是奧克拉荷馬大學電機與計算機工程學院的助理教授。她擁有生物醫學工程博士學位，專注於基於表面增強拉曼散射（SERS）的癌症診斷分子分析。目前，哈爾達夫尼卡博士正在開發基於拉曼光譜的過程分析技術，用於癌症診斷。她的研究興趣還包括開發正交方法，以研究腫瘤微環境中的細胞相互作用。
馬里奧·A·哈爾頓博士是麥吉爾大學生物工程系的教學講師。他擁有化學與生物工程博士學位，並在生物製藥製造方面擁有數年的經驗。他的科學專長包括開發和強化基於哺乳動物細胞的重組蛋白生產過程，專注於整合細胞壓力反應和代謝，以理解和工程生物系統的反應，旨在開發用於治療生物製劑的高性能製造過程。