希望學生熟習並主動思考關於醫藥品工業的GMP 工廠規範，建構，法規，申請，查廠，維護。俾使學生能思辨在製藥工程與藥物輸送劑型設計上的全面性知識與技術。本課程將涵蓋基本的大分子藥物劑型與輸送、細胞生物學概念，將回顧介紹藥物傳輸劑型、並融合基因藥物製備、基因編輯、基因重組等分子生物技術，基因治療的方法，使用的載體技術，製備方法，臨床實驗，以及siRNA, mRNA, micro RNA, pDNA, ssDNA, ASO…等製備成基因藥物的應用。
The topics of this course cover basic cell biology, would introduce the perception of molecular engineering techniques including of genetic engineering, gene editing and genetic recombination. Besides, I would introduce the cutting-edge methods of gene therapy, including the preparation of vectors, delivery technique, clinical trials, and the usage of siRNA, mRNA, micro RNA, pDNA, ssDNA, ASO as gene drugs.
先修科目Prerequisites
細胞生物學，有機化學
Cell Biology, Organic Chemistry
教學方式Teaching Methods
同步教學(使用虛擬教室如：Moodle同步教室、Google Meet、Microsoft Classroom等)
Synchronous Online Learning
講課
Lecturing
小組討論、腦力激盪(如案例討論、電影欣賞等)
Group discussion, Brain storming, e.g., Case study, Event discussion, Movie review
觀察與資料收集、採訪
Observation and data collection, Interview
評量方式Assessment
期末報告
Final report
課堂參與與表現
Class involvement
期末報告以及與同學討論計分方式
參考書目Reference
Gene and Cell Therapy: Therapeutic Mechanisms and Strategies, Fourth Edition. January 20, 2015 by CRC Press
教學進度Course Schedule
2022/02/24 課程介紹與展望
Introduction and course prospection
林進裕(Lin, Chin-Yu) 2022/03/03 藥品開發流程、綜合討論
Pharmaceutical development process, discussion
林進裕(Lin, Chin-Yu) 2022/03/10 劑型與生物藥物簡介、綜合討論-I
Dosage forms and bio-pharmaceutics, discussion-I
林進裕(Lin, Chin-Yu) 2022/03/17 劑型與生物藥物簡介、綜合討論-II
Dosage forms and bio-pharmaceutics, discussion-II
林進裕(Lin, Chin-Yu) 2022/03/24 藥品研究開發與輸送簡介、綜合討論-I
Development of Biodrug and Delivery, general discussion-I
林進裕(Lin, Chin-Yu) 2022/03/31 藥品研究開發與輸送簡介、綜合討論-II
Development of Biodrug and Delivery, general discussion-II
林進裕(Lin, Chin-Yu) 2022/04/07 生技製藥工業與市場、GMP工廠規範，工廠建構與考量、綜合討論
Bio-pharmaceutics Industry and Market, GMP regulatory, construction
林進裕(Lin, Chin-Yu) 2022/04/14 期中考試週
Mid-term exam
林進裕(Lin, Chin-Yu) 2022/04/21 基因工程—原核細胞生物、黴菌與酵母菌、綜合討論-I
Genetic Engineering -- Procaryote, Yeast and Fungi, general discussion-I
林進裕(Lin, Chin-Yu) 2022/04/28 基因工程—原核細胞生物、黴菌與酵母菌、綜合討論-II
Genetic Engineering -- Procaryote, Yeast and Fungi, general discussion-II
林進裕(Lin, Chin-Yu) 2022/05/05 病毒性、非病毒性基因治療載體技術、綜合討論
Viral, Non-Viral Gene Therapy Vector, general discussion
林進裕(Lin, Chin-Yu) 2022/05/12 基因治療與幹細胞技術、綜合討論
Gene Therapy and Stem Cell Technology, general discussion
林進裕(Lin, Chin-Yu) 2022/05/19 ASO based 基因治療、pDNA, ssDNA, mRNA based基因治療、RNAi based基因治療、綜合討論
ASO Based Gene Therapy, RNAi Based Gene Therapy, pDNA, ssDNA, mRNA Based Gene Therapy, general discussion
林進裕(Lin, Chin-Yu) 2022/05/26 基因治療臨床實驗，案例與規範、綜合討論
Clinical Trials, case reports and Regulatory Issues, general discussion
林進裕(Lin, Chin-Yu) 2022/06/02 疫苗，抗生素與重組蛋白、綜合討論
Vaccine, Antibiotics, and Recombinant Protein, general discussion
林進裕(Lin, Chin-Yu) 2022/06/09 專題討論與論文選讀-I
Discussion and Oral Presentation-I
林進裕(Lin, Chin-Yu) 2022/06/16 專題討論與論文選讀-II
Discussion and Oral Presentation-II
林進裕(Lin, Chin-Yu) 2022/06/23 期末報告
Final Report
林進裕(Lin, Chin-Yu)