Challenges in Protein Product Development
暫譯: 蛋白質產品開發中的挑戰

在本卷中，作者討論了當前生物技術劑型開發中面臨的許多重大挑戰，提供指導、共享經驗以及對如何最佳解決這些潛在問題的深思熟慮。隨著治療性重組蛋白領域進入其第四個十年，生物製藥市場變得越來越具競爭力，各公司越來越多地投入資源開發創新的生物製藥，以滿足未被滿足的醫療需求。通常，藥物開發科學家會遇到特定蛋白質的挑戰性藥物性質，或是產品在穩定性、製造以及臨床前或臨床期望下所面臨的要求，以及不斷演變的監管期望和環境。此外，還出現了一些需要密切評估的新發現，例如與輔料質量、加工、黏度和設備相容性及給藥、溶解度和乳濁度以及容器封閉選擇相關的問題。文獻在討論這些關鍵要素時差異很大，並且並不存在共識。這一主題在生物技術行業以及全球的學術研究者和監管機構中受到廣泛關注。因此，本書對於在製藥和生物技術行業中活躍的商業領導者、研究人員、配方和工藝開發科學家、分析科學家、質量保證和質量控制人員、監管人員、製造領導者以及監管機構的專家審查員都具有興趣。

Nicholas W. Warne is currently Senior Director of Formulations and Drug Product Process Development at Pfizer. Dr. Warne has 28 years of industrial experience focusing on biologics formulation development, dosage form design and manufacturing process development. He and his team have been fortunate to have contributed to the licensure of 10 biologics including clotting factors, growth proteins, mabs, vaccines and ADCs. Dr. Warne holds numerous protein formulation patents and, with his group, has made over 100 presentations at national meetings and in journals. Prior to his position at Pfizer, Dr. Warne had positions of increasing responsibility at Wyeth and Genetics Institute, and has been based in Andover, Massachusetts.

Dr. Warne received his PhD in Chemistry from Purdue University under the guidance of Professor Michael Laskowski Jr. He received his BS in Biochemistry, with Distinction in Research, from the University of Rochester.

Hanns-Christian Mahler. Since September 2015, Dr. Mahler is leading the Drug Product services organization at Lonza AG, a leading service provider for the Pharma and Biotech industry. Prior this position, he led the department Pharmaceutical Development & Supplies, Biologics EU at Roche, Basel, Switzerland from 2010 to 2015 and as Head of Formulation R&D Biologics, Roche, Basel, from 2005 to 2010. From 2000-2005, Dr. Mahler was working at Merck KGaA, Darmstadt, Germany as Principal Formulation Scientist, Lab Manager for Protein Formulation Development and Clinical Trial Manufacturing and CMC Team leader for Erbitux during its submission and launch phase.

Dr. Mahler studied Pharmacy at the University of Mainz, Germany, holds in Ph.D. in Toxicology from the Institute of Pharmacy, University of Mainz and Pharmacist specialization degrees in Toxicology & Ecology and Pharmaceutical Technology. He was further trained in Economy and Marketing. Dr. Mahler obtained his venia legendi (german Habilitation) from the University of Frankfurt/Germany in 2010 and is adjunct faculty and lecturer at the universities of Frankfurt (Germany), and Basel (Switzerland). He was elected an AAPS Fellow in November 2013, nominated extraordinary Professor for Pharmaceutical Technology in November 2015 and received the PDA Distinguished Service Award in 2018.

Nicholas W. Warne 目前擔任輝瑞（Pfizer）製劑及藥品製程開發的高級總監。Warne 博士擁有 28 年的產業經驗，專注於生物製劑的配方開發、劑型設計及製造過程開發。他和他的團隊有幸參與了 10 種生物製劑的許可，包括凝血因子、生長蛋白、單克隆抗體（mabs）、疫苗和抗體藥物偶聯物（ADCs）。Warne 博士擁有多項蛋白質配方專利，並與其團隊在全國會議和期刊上發表了超過 100 篇報告。在加入輝瑞之前，Warne 博士曾在 Wyeth 和 Genetics Institute 擔任越來越高的職位，並在麻薩諸塞州安多佛工作。

Warne 博士在普渡大學（Purdue University）獲得化學博士學位，指導教授為 Michael Laskowski Jr. 教授。他在羅徹斯特大學（University of Rochester）獲得生物化學學士學位，並在研究中獲得優異成績。

Hanns-Christian Mahler 自 2015 年 9 月以來，Mahler 博士領導瑞士 Lonza AG 的藥品服務組織，該公司是製藥和生技產業的領先服務提供商。在此之前，他於 2010 年至 2015 年在瑞士巴塞爾的羅氏（Roche）擔任生物製劑歐洲藥品開發與供應部門的負責人，並於 2005 年至 2010 年擔任羅氏生物製劑配方研發部門的負責人。2000 年至 2005 年，Mahler 博士在德國達姆施塔特的默克（Merck KGaA）擔任主要配方科學家，負責蛋白質配方開發和臨床試驗製造，並在 Erbitux 的申請和上市階段擔任 CMC 團隊負責人。

Mahler 博士在德國美因茨大學（University of Mainz）學習藥學，並在美因茨大學藥學研究所獲得毒理學博士學位，還擁有毒理學與生態學及藥物技術的藥劑師專業資格。他還接受了經濟學和市場營銷的進一步培訓。Mahler 博士於 2010 年在德國法蘭克福大學獲得 venia legendi（德國 Habilitation），並在法蘭克福（德國）和巴塞爾（瑞士）的大學擔任兼任教員和講師。他於 2013 年 11 月被選為 AAPS Fellow，2015 年 11 月被提名為藥物技術的特聘教授，並於 2018 年獲得 PDA 傑出服務獎。