課程資訊
課程名稱
 生技製藥一
PHARMACEUTICAL BIOTECHNOLOGY(Ⅰ) 
開課學期
 98-1 
授課對象
 醫學院  藥學研究所  
授課教師
 孔繁璐 
課號
 PHARM5006 
課程識別碼
 423 U0530 
班次
  
學分
 1 
全/半年
 半年 
必/選修
 選修 
上課時間
 星期五3(10:20~11:10) 
上課地點
  
備註
 與何蘊芳合開
總人數上限：15人 
Ceiba 課程網頁
 http://ceiba.ntu.edu.tw/981pharma 
課程簡介影片
 
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課程概述

This is the first part of a half-year survey course aimed to introduce Pharmacy students to various biotechnology-related techniques and their applications in the discovering and manufacturing of biopharmaceuticals as well as biomedical research. The course begins with a general introduction to the physicochemical characteristics, pharmacology, and formulation of proteins and the basics in protein production and manufacturing. Since the production, downstream processing, and characterization of biopharmaceuticals are in many aspects very different from conventional small molecular therapeutics, issues relevant to the handling and delivering of those products are also highlighted. Finally, several approved and potential biopharmaceuticals are discussed. Two hours of lecture per week.  

課程目標
 to introduce Pharmacy students to various biotechnology-related techniques and their applications in the discovering and manufacturing of biopharmaceuticals as well as biomedical research 
課程要求
  
預期每週課後學習時數
  
Office Hours
 每週五 12:10~13:00 
指定閱讀
  
參考書目
 References：
1. (CS) D. J.A. Crommelin, R.D. Sindelar (2002), Pharmaceutical Biotechnology – An Introduction for Pharmacists and Pharmaceutical Scientists, Hardwood Academic Publishers
2. (KM) O. Kayser, R.H. Muller (2004), Pharmaceutical Biotechnology – Drug Discovery and Clinical Applications, Wiley-VCH
 
評量方式
(僅供參考)
  
No.
項目
百分比
說明
1. 
 Class participation 
10% 
  
2. 
 Written Exam 
90% 
 one mid-term  
 
課程進度
週次
日期
單元主題
第1週
 9/18  Introduction 
第2週
 9/25  Molecular Biotechnology/Gene Expression and Its Regulation (I)
Chapter 1 (CS), Chapters 2 and 3 (KM) – gene expression, specific DNA technology (sequencing, hybridization, PCR, etc.), recombinant DNA technology (cloning), introduction to expression systems (prokaryotic/eukaryotic, microbes /animal cells/plant cells)
 
第3週
 10/02  Molecular Biotechnology/Gene Expression and Its Regulation (II)
Chapters 1 and 6 (CS) – principles of site directed mutagenesis & applications in improving properties of proteins (protein engineering), the impact of biotechnology on drug discovery
 
第4週
 10/09  Production of Biotech Compounds
Chapter 3 (CS), Chapters 2, 3, and 6 (KM) – cultivation in various expression systems (prokaryotic/eukaryotic, microbes/animal cells/plant cells), downstream processing/characterization/bioanalysis (KM Ch. 6), issues to consider in production and purification processes
 
第5週
 10/16  Physicochemical properties, structure and stability of peptides & proteins
Chapter 2 (CS) – protein structure, protein folding, protein stability, analytical techniques
 
第6週
 10/23  Formulation of Biotech Products, including Biopharmaceutical Considerations
Chapter 4 (CS), Chapter 9 (KM) – microbiological considerations, excipients, shelf life, delivery (routes of administration and absorption enhancement, rate controlled and target site specific delivery)
 
第7週
 10/30  PK/PD of Peptide and Protein Drugs/Dispensing biotechnology products
Chapter 5 (CS), Chapter 8 (KM) – also includes protein binding, interspecies scaling, heterogeneity of protein therapeutics, chemical modifications, immunogenicity
Chapter 18 (CS) – storage, handling, preparation, administration, outpatient/home care issues
 
第8週
 11/06  Midterm Exam 
第9週
 11/13  Patents in the Pharmaceutical Biotechnology Industry/Drug Approval in the EU and the United States
Chapters 10 and 11 (KM)