一 課程說明	此課程將會介紹生物技術產業目前產值最大的蛋白質藥物產業, 內容包括上游的細胞株
<br>建構、細胞培養、蛋白質生產、純化等製程、藥物配方、穩定性研究、工廠及製程認證、整體製程、法
<br>規介紹、臨床實驗設計、產業特性介紹、內部與外部查廠、品管及分析方法建立等。本課程邀請業界講
<br>師授課，將以業界觀點及需求出發，讓學生了解業界需求的技術與技能，以縮小產學落差。
<br>This course will introduce biotechnology in all aspects for protein and enzyme production. 
<br>Currently its value is the largest in the pharmaceutical industry, including upstream cell line 
<br>construction, cell culture, protein production and purification processes, pharmaceutical 
<br>formulations, stability studies, factory and process certification, the whole process, and 
<br>regulations presentation, clinical trial design, characteristics of the industry reports, internal 
<br>and external investigation plant, quality control and analysis method and the like. The course 
<br>instructors invite the industry, will be the industry's views and needs, so that students 
<br>understand the technology and skills needs of the industry, in order to reduce industry-
<br>academia gap.
<br>二 指定用書	無
<br>三 參考書籍	無
<br>四 教學方式	邀請生技產業界人士上課為主, 全英語授課
<br>五 教學進度	1. Interview skills and enhancement of learning capability,
<br>2. Introduction of biotech industry
<br>3. Cell line construction, cell culture and protein production
<br>4. Purification processes
<br>5. Formulation and stability studies
<br>6. Facility validation and process validation 
<br>7. Manufacturing processes from RCB-MCB-WCB and documentation, second site storage
<br>8. Regulatory filing, clinical trials design for phase 1, 2 and 3 and 4
<br>9. Business deal structure, partnership, CMO (contract manufacturing organization), contract 
<br>lab
<br>10. Internal and external audits
<br>11. QC assay validation, raw material testing, and analytical Development
<br>12. What is Quality unit?
<br>六 成績考核	一次期中考 (mid term score) is 35%, final score is 35%, homework 5%, final 
<br>report is 25%
<br>七 講義位址	
<br>