The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide "one stop shopping" for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.
生物技術/生物製藥領域的快速成長促成了工程抗體的發明，例如抗體藥物偶聯物（Antibody Drug Conjugates, ADCs）、雙特異性T細胞接合劑（Bispecific T-cell engager, BITES）、雙變量域（Dual Variable Domain, DVD）抗體以及融合蛋白，這些目前正被用作免疫學、腫瘤學及其他疾病狀況的治療劑。監管機構對抗體基產品的開發和製造提高了標準，期望看到基於健全科學的深入理解產品和過程的設計質量（Quality by Design, QbD）元素的使用。藥物傳遞系統已成為治療中越來越重要的一部分，大多數自我給藥的生物製藥產品正以組合產品的形式進入市場。市場調查顯示，對於一本能提供最新科學和工程進展的“單一購物”書籍的需求強烈，這些進展是在過去幾年中在生物製藥產品開發領域取得的。這本名為《生物製藥藥物裝置產品的開發》的新書是生物製藥行業、學術界或監管機構的科學家和工程師的參考文本。這本新書由該領域的專家撰寫的深刻章節回顧了基本原則，涵蓋了最近的技術進展，並提供了與抗體基產品的開發和製造相關的案例研究和監管策略。它涵蓋的主題包括在藥物發現過程中早期預配方研究的重要性，以影響分子的選擇進行開發、新型模式的配方策略，以及用於表徵它們的分析技術。它還針對後期開發的重要考量，例如開發穩健的配方和過程，包括製造單元操作的過程工程和建模、分析可比性研究的設計，以及主要容器（預填充注射器和小瓶）的表徵。最後，本書的後半部分回顧了確保以患者為中心的傳遞系統設計的開發和批准的關鍵考量。這涉及到不斷演變的監管框架，並從美國和歐盟的行業專家獲得觀點，國際標準的角色，設計控制/風險管理，人因工程及其在產品開發和監管批准過程中的重要性，以及對於在臨床試驗中使用的裝置與即將上市的裝置之間的橋接的風險基礎方法的回顧。最後，書中貫穿提供了案例研究。典型的讀者將擁有生物學和/或工程學學位，包括在生物製藥領域工作的研究人員、科學領導者、行業專家和技術開發者。
Feroz Jameel heads the formulation development function of New Biological Entities at AbbVie, Lake County, IL, where he is involved in early and late stage development of parenteral products. Prior to joining AbbVie, Feroz worked at Baxter Biosciences and Amgen. At Baxter, Feroz was involved in the end-to-end development and tech transfer of recombinant Factor VIII (RecombinateTM). At Amgen, Feroz worked over several years in the Parenteral Delivery Drug Product and Process Development where he was involved in the drug product development and tech transfer of several parenteral products including Enbrel(R), Nplate(R), Repatha(R) and Blincyto(R). Feroz received his Master's degree in Pharmaceutics from the University of Delhi and Ph.D. in Pharmaceutics (Pharmaceutical Sciences) from the University of Connecticut. His publications include over 20 peer-reviewed manuscripts, over 20 presentations, and several book chapters. He is the co-editor of the books "Formulation and Process Development Strategies for Manufacturing of Biopharmaceuticals" and "Quality by Design for Biopharmaceutical Drug Product Development". He has held several leadership positions at the AAPS including chair of "Freezing and Drying Technologies" and led the industrial consortium for Lyo QbD. Currently, he is leading the industrial consortium on "Best practices/guidelines for validation of Lyophilization process and products". He is a recipient of 2 patents in lyophilization formulation and lyophilization process development. In addition to corporate awards, Henry Kramer from Baxter and Volwiler Award from AbbVie, Feroz received several awards including the AAPS and PDA's Fred Simon's award for the best paper published in the PDA Journal of Pharmaceutical Science and Technology. He has also chaired several symposia on the development of biological products. John Skoug has more than 30 years of pharmaceutical industry experience and specializes in CMC product development across all stages of discovery and development. Through early 2019, he was Senior Director in AbbVie's drug product R&D organization, where he held a number of roles including head of preformulation, solid-oral formulation development, drug/device combination product development and CMC program management. In these roles, he was responsible for CMC technical strategy and execution for small molecule programs and combination product programs for biologics. Prior to AbbVie, John held similar scientific and leadership positions in Pharmaceutical R&D in Upjohn/Pharmacia/Pfizer. John founded FarmCMC LLC in 2019 to leverage his technical and leadership expertise to help small and medium sized biopharmaceutical companies develop novel therapeutic assets and delivery systems through early and late stage development. John received a Ph.D. in Analytical Chemistry from Purdue University, has more than 20 publications and presentations, and has served in various capacities with the American Association of Pharmaceutical Scientists, the Combination Product Coalition, and the IQ Consortium, where he was recognized with the Outstanding Service award in 2015.
Robert Nesbitt is a group leader in Human Factors and Drug Delivery System development in AbbVie's Combination Product Development group in Lake County, IL. Bob has a BS in Engineering Operations from Iowa State University, and an MBA from the University of Chicago. He joined AbbVie in January 2015, after 16 years at Eli Lilly and Company, where he drove patient-centered design into device development, and where he supported the design and launch of nine different Lilly devices still in use today around the world. Prior to Lilly, Bob led process engineering and manufacturing for both Roche Diagnostics' blood glucose monitoring and Baxter Healthcare's Custom Sterile Procedure pack businesses. He has been active in the development of ISO standards for medical devices since 1999; is the US Technical Advisory Group (TAG) co-chair for AAMI's ISO/TC76 and TC84 committees and has been Convenor of multiple working groups. He holds a patent for inhaled drug delivery device design, and has received Lilly's "Changing the World" award (2001), "President's Award" (2006) and was recognized as one of Lilly's "Top 100 Innovators" (2014).
Feroz Jameel 負責 AbbVie 位於伊利諾伊州湖郡的新生物實體的配方開發功能，參與注射產品的早期和晚期開發。在加入 AbbVie 之前，Feroz 曾在 Baxter Biosciences 和 Amgen 工作。在 Baxter，Feroz 參與了重組第八因子 (RecombinateTM) 的端到端開發和技術轉移。在 Amgen，Feroz 在注射給藥藥品和過程開發方面工作了幾年，參與了多種注射產品的藥品開發和技術轉移，包括 Enbrel(R)、Nplate(R)、Repatha(R) 和 Blincyto(R)。Feroz 獲得了德里大學的藥劑學碩士學位，以及康乃爾大學的藥劑學博士學位（藥學科學）。他的出版物包括超過 20 篇同行評審的手稿、超過 20 次演講和幾個書章。他是《生物製藥製造的配方和過程開發策略》和《生物製藥藥品開發的設計品質》兩本書的共同編輯。他在 AAPS 擔任過多個領導職位，包括「冷凍和乾燥技術」的主席，並領導了 Lyo QbD 的產業聯盟。目前，他正在領導「冷凍乾燥過程和產品驗證的最佳實踐/指導方針」的產業聯盟。他在冷凍乾燥配方和冷凍乾燥過程開發方面擁有 2 項專利。除了企業獎項外，Feroz 還獲得了來自 Baxter 的 Henry Kramer 獎和 AbbVie 的 Volwiler 獎，並獲得了 AAPS 和 PDA 的 Fred Simon 獎，以表彰他在 PDA 藥學科學與技術期刊上發表的最佳論文。他還主持過多個有關生物產品開發的研討會。
John Skoug 擁有超過 30 年的製藥行業經驗，專注於發現和開發各階段的 CMC 產品開發。在 2019 年初，他擔任 AbbVie 藥品產品研發組織的高級總監，擔任過多個角色，包括預配方、固體口服配方開發、藥物/裝置組合產品開發和 CMC 項目管理的負責人。在這些角色中，他負責小分子計劃和生物製劑的組合產品計劃的 CMC 技術策略和執行。在加入 AbbVie 之前，John 在 Upjohn/Pharmacia/Pfizer 的製藥研發中擔任過類似的科學和領導職位。John 在 2019 年創立了 FarmCMC LLC，利用他的技術和領導專業知識，幫助中小型生物製藥公司通過早期和晚期開發開發新型治療資產和給藥系統。John 獲得了普渡大學的分析化學博士學位，擁有超過 20 篇出版物和演講，並在美國藥學科學協會、組合產品聯盟和 IQ 聯盟中擔任過各種職位，並於 2015 年獲得傑出服務獎。
Robert Nesbitt 是 AbbVie 位於伊利諾伊州湖郡的組合產品開發小組中人因工程和藥物給藥系統開發的組長。Bob 擁有愛荷華州立大學的工程運營學士學位，以及芝加哥大學的工商管理碩士學位。他於 2015 年 1 月加入 AbbVie，此前在 Eli Lilly and Company 工作了 16 年，推動以患者為中心的設計進入裝置開發，並支持九種不同 Lilly 裝置的設計和推出，這些裝置至今仍在全球使用。在 Lilly 之前，Bob 負責 Roche Diagnostics 的血糖監測和 Baxter Healthcare 的定制無菌程序包業務的過程工程和製造。他自 1999 年以來一直積極參與醫療器械 ISO 標準的開發；是 AAMI 的 ISO/TC76 和 TC84 委員會的美國技術諮詢小組 (TAG) 共同主席，並擔任多個工作組的召集人。他擁有一項吸入藥物給藥裝置設計的專利，並獲得了 Lilly 的「改變世界」獎（2001 年）、「總統獎」（2006 年），並於 2014 年被認定為 Lilly 的「前 100 名創新者」之一。
