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課程名稱 |
生技製藥一
PHARMACEUTICAL BIOTECHNOLOGY(Ⅰ) |
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開課學期 |
97-1 |
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授課對象 |
學程 分子醫藥學程 |
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授課教師 |
孔繁璐 |
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課號 |
PHARM5006 |
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課程識別碼 |
423 U0530 |
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班次 |
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學分 |
1 |
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全/半年 |
半年 |
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必/選修 |
選修 |
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上課時間 |
星期五3(10:20~11:10) |
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上課地點 |
基1234 |
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備註 |
與何蘊芳合開
總人數上限：40人 |
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課程簡介影片 |
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核心能力關聯 |
核心能力與課程規劃關聯圖 |
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課程大綱
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課程概述 |
This is the first part of a half-year survey course aimed to introduce 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. |
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課程目標 |
To introduce students to various biotechnology-related techniques and their applications in the discovering and manufacturing of biopharmaceuticals as well as biomedical research. |
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課程要求 |
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預期每週課後學習時數 |
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Office Hours |
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指定閱讀 |
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參考書目 |
1. D.J.A. Crommelin, R.D. Sindelar (2002), Pharmaceutical Biotechnology — An Introduction for Pharmacists and Pharmaceutical Scientists, Hardwood Academic Publishers
2. O. Kayser, R.H. Muller (2004), Pharmaceutical Biotechnology — Drug Discovery and Clinical Applications, Wiley-VCH |
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評量方式
(僅供參考) |
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No. |
項目 |
百分比 |
說明 |
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1. |
Written Exam |
90% |
one mid-term |
2. |
Class participation |
10% |
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週次 |
日期 |
單元主題 |
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第1週 |
9/19 |
Introduction |
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第2週 |
9/26 |
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) |
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第3週 |
10/03 |
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 |
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第4週 |
10/10 |
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 |
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第5週 |
10/17 |
Physicochemical properties, structure and stability of peptides & proteins Chapter 2 (CS) — protein structure, protein folding, protein stability, analytical techniques |
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第6週 |
10/24 |
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) |
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第7週 |
10/31 |
Patents in the Pharmaceutical Biotechnology Industry/Drug Approval in the EU and the United States Chapters 10 and 11 (KM) |
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第8週 |
11/07 |
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 |
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第9週 |
11/14 |
Midterm Exam |
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