Bioprocess and Analytics Development for Virus-Based Advanced Therapeutics and Medicinal Products (Atmps)

本書回顧了在快速發展的病毒疫苗和基因治療領域中的知識、方法和可用技術。它還突顯了生物過程開發和病毒及病毒載體分析的新創工具和跨學科技術。因此，本書提供了一個及時且高度相關的資源，因為當前藥物研究的進展已見疫苗和先進治療及醫療產品（ATMPs）的興起，這些產品依賴於病毒的力量。然而，開發創造這種常被稱為「神奇子彈」（即基因治療）所需的生物過程和分析仍然是一項極具挑戰性且成本高昂的任務。本書提供了克服病毒載體開發過程中所有必要步驟的障礙和困難的策略，從可擴展性到純化方法和質量控制。

本書適合在學術界或產業界工作的研究人員，以及追求病毒學職業的研究生。

Dr. Saurabh Gautam is a Lab Head/Principal Scientist at ViraTherapeutics GmbH and Boehringer Ingelheim International GmbH based in Innsbruck, Austria. He is leading a group for bioprocess development and manufacturing of oncolytic viruses, viral vectors, and vaccines. So far, he has helped and contributed in bringing 3 advanced therapeutics and medicinal products (ATMPs) to clinics.

Previously, Dr. Gautam has also worked at the Max Planck Institute of Biochemistry, Martinsried, Germany within the group of Director Prof. Dr. Ulrich Hartl after obtaining his PhD from Indian Institute of Technology Delhi, India in 2016. He is also a recipient of highly prestigious Marie Curie individual fellowship from European Commission for his work at Max Planck Institute. More personally, he is interested in playing soccer, hiking, and cooking.

Dr. Abhilash I. Chiramel is a Principal Scientist at Boehringer Ingelheim Pharma GmbH & Co. KG and Head Of Therapeutic Virus Development Laboratory 2 (TVD2) within the Virus Therapeutics Center, Development Biologicals department. He is employing his expertise as a virologist to establish analytical methods to characterize oncolytic viruses and viral vectors for gene therapy. He has 17 years of experience researching the biology of viruses. His research interests fall in the axis of cell biology and innate immunity to viral infections. His work has been published in multiple journals in the field of virology - from elucidating ultrastructural details of RNA virus replication to characterizing innate immune responses to pathogenic RNA virus infections.

Dr. Roland Pach is the global CMC Analytical Lead in the cancer vaccines and cell- & gene therapy (CGT) area of Roche more than 13 years. In his assigned area of ATMPs, he represents Roche in external development projects, industrial consortiums like CGT BioPhorum, USP, CMO/CDMOs (audits) and numerous due diligences of in-licensing candidates or companies in the CGT fields. Together with his collaboration partners, he drove the definition & implementation of the control-, analytical development-, analytical comparability- and submission strategies and its cognate technologies.
In his second role at Roche as global technical development leader, he had led successfully new formats like immunotoxins from pre-clinics into entry to human (EiH).
Briefly, Dr. Roland Pach studied Life Sciences at the Biozentrum of the University Basel and holds a PhD in molecular parasitology at the University Fribourg analysing the expression of and mitochondrial trafficking of transgenic RNA in protozoan pathogens.

He started his industrial career in the role of the production head of DiTe vaccines at Berna Biotech (former Swiss Vaccine and Serum Institute). Subsequently he was leading the Analytical Development - and Process Analytics department covering diverse platforms like bacterial conjugate-, virosomal- and attenuated viral vaccines.

Prior Roche, Roland led the QC department of Bio-Process Development Drug Substance at Merck-Serono and advanced the implementation of QbD and Design Space at his labs applied to Interleukin- and Fc-fusion based drug molecules.

Dr. Saurabh Gautam 是 ViraTherapeutics GmbH 和 Boehringer Ingelheim International GmbH 的實驗室負責人/首席科學家，工作地點位於奧地利因斯布魯克。他領導一個團隊，專注於腫瘤溶解病毒、病毒載體和疫苗的生物製程開發與製造。迄今為止，他已經協助並貢獻了三種先進療法和藥品（ATMPs）進入臨床試驗。

在此之前，Gautam 博士曾在德國馬克斯·普朗克生物化學研究所的 Ulrich Hartl 教授團隊工作，並於 2016 年從印度德里印度理工學院獲得博士學位。他還因在馬克斯·普朗克研究所的工作而獲得歐洲委員會頒發的極具聲望的 Marie Curie 個人獎學金。更個人化地說，他對踢足球、健行和烹飪感興趣。

Dr. Abhilash I. Chiramel 是 Boehringer Ingelheim Pharma GmbH & Co. KG 的首席科學家，並擔任病毒治療中心生物製劑部門的治療病毒開發實驗室 2 (TVD2) 的負責人。他利用作為病毒學家的專業知識，建立分析方法以表徵腫瘤溶解病毒和基因治療的病毒載體。他在病毒生物學研究方面擁有 17 年的經驗，研究興趣涵蓋細胞生物學和對病毒感染的先天免疫反應。他的研究成果已發表於多個病毒學領域的期刊，從闡明 RNA 病毒複製的超微結構細節到表徵對病原性 RNA 病毒感染的先天免疫反應。

Dr. Roland Pach 是羅氏公司癌症疫苗及細胞與基因治療 (CGT) 領域的全球 CMC 分析負責人，已有超過 13 年的經驗。在他負責的 ATMPs 領域，他代表羅氏參與外部開發項目、工業聯盟如 CGT BioPhorum、USP、CMO/CDMOs（審核）以及多項 CGT 領域的盡職調查。與合作夥伴一起，他推動了控制、分析開發、分析可比性和提交策略及其相關技術的定義與實施。

在羅氏的第二個角色中，作為全球技術開發負責人，他成功地將免疫毒素等新型態從臨床前階段推進至人類試驗（EiH）。簡而言之，Roland Pach 博士在巴塞爾大學的生物中心學習生命科學，並在弗里堡大學獲得分子寄生蟲學博士學位，分析轉基因 RNA 在原生動物病原體中的表達和線粒體運輸。

他在 Berna Biotech（前瑞士疫苗和血清研究所）擔任 DiTe 疫苗的生產負責人，開始了他的工業生涯。隨後，他領導了涵蓋多種平台的分析開發和過程分析部門，包括細菌結合疫苗、病毒囊泡疫苗和減毒病毒疫苗。

在加入羅氏之前，Roland 曾在 Merck-Serono 領導生物製程開發藥物物質的 QC 部門，並推進了 QbD 和設計空間在其實驗室中應用於白介素和 Fc 融合藥物分子的實施。