課程資訊
課程名稱
生技製藥一
PHARMACEUTICAL BIOTECHNOLOGY(Ⅰ) 
開課學期
95-1 
授課對象
學程  分子醫藥學程  
授課教師
孔繁璐 
課號
PHARM5006 
課程識別碼
423 U0530 
班次
 
學分
全/半年
半年 
必/選修
選修 
上課時間
星期四5(12:20~13:10) 
上課地點
1234 
備註
與何蘊芳合開
總人數上限:40人 
 
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課程概述

後建 

課程目標
 
課程要求
 
預期每週課後學習時數
 
Office Hours
 
指定閱讀
 
參考書目
 
評量方式
(僅供參考)
 
No.
項目
百分比
說明
1. 
Written Exam  
90% 
one mid-term  
2. 
Class participation 
10% 
 
 
課程進度
週次
日期
單元主題
第1週
9/21  Introduction 
第2週
9/28  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
10/05  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
10/12  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
10/19  Physicochemical properties, structure and stability of peptides & proteins
Chapter 2 (CS) — protein structure, protein folding, protein stability, analytical techniques
 
第6週
10/26  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
11/02  Patents in the Pharmaceutical Biotechnology Industry/Drug Approval in the EU and the United States
Chapters 10 and 11 (KM)
 
第8週
11/09  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9週
11/16  Midterm Exam