• Basic information
• Learning outcomes
• Contents
• Assessment
• Workload

Learning outcomes

Upon successful completion of this course, students will be able to:

1. Define biopharmaceuticals and pharmaceutical biotechnology.

   Contribution to Program Outcomes

   1. Acquire knowledge on current bioengineering applications from the industrial and scientific aspects
   2. Understand design and production processes in bioengineering applications.
   3. Conduct and develop bioengineering applications for relevant sectors such as health and agricultural industry.

   Method of assessment

   1. Written exam
2. Define process development and manufacturing concept for biopharmaceutical products.

   Contribution to Program Outcomes

   1. Understand design and production processes in bioengineering applications.
   2. Apply mathematical analysis and modeling methods for bioengineering design and production processes.
   3. Conduct and develop bioengineering applications for relevant sectors such as health and agricultural industry.
   4. Design processes for the investigation of bioengineering problems, collect data, analyze and interpret the results.

   Method of assessment

   1. Written exam
3. Define and apply upstream process in biopharmaceutical productions.

   Contribution to Program Outcomes

   1. Acquire knowledge on biological, chemical, physical and mathematical principles which constitute the basis of bioengineering applications
   2. Understand design and production processes in bioengineering applications.
   3. Combine, Interpret, and analyze different subfields of bioengineering

   Method of assessment

   1. Written exam
4. Define bioreactors and cell culture process parameters.

   Contribution to Program Outcomes

   1. Acquire knowledge on biological, chemical, physical and mathematical principles which constitute the basis of bioengineering applications
   2. Understand design and production processes in bioengineering applications.
   3. Apply mathematical analysis and modeling methods for bioengineering design and production processes.
   4. Design processes for the investigation of bioengineering problems, collect data, analyze and interpret the results.

   Method of assessment

   1. Written exam
5. Identify scale-up and scale-down strategies in mammalian cell culture processes.

   Contribution to Program Outcomes

   1. Acquire knowledge on biological, chemical, physical and mathematical principles which constitute the basis of bioengineering applications
   2. Understand design and production processes in bioengineering applications.
   3. Design processes for the investigation of bioengineering problems, collect data, analyze and interpret the results.

   Method of assessment

   1. Written exam
6. Define downstream process in biopharmaceutical productions.

   Contribution to Program Outcomes

   1. Acquire knowledge for research methods which are required to develop novel application methods
   2. Conduct and develop bioengineering applications for relevant sectors such as health and agricultural industry.
   3. Combine, Interpret, and analyze different subfields of bioengineering

   Method of assessment

   1. Written exam
7. Define basic principles on process validation for pharmaceutical.

   Contribution to Program Outcomes

   1. Acquire knowledge on biological, chemical, physical and mathematical principles which constitute the basis of bioengineering applications
   2. Conduct and develop bioengineering applications for relevant sectors such as health and agricultural industry.

   Method of assessment

   1. Written exam

Contents
Week 1:	Introduction to Mammalian Cell Culture Princibles
Week 2:	Introduction to Medical Biotechnology
Week 3:	Biopharmaceuticals and Pharmaceutical Biotechnology
Week 4:	General Overview of Process Development and Manufacturing Concept for Biopharmaceutical Products Determination of The Project Topic
Week 5:	Upstream Process in Biopharmaceutical Productions: Mammalian Cell Cultures for Biologics Manufacturing & Bioreactors and Cell Culture Process Parameters
Week 6:	Upstream Process in Biopharmaceutical Productions: Mammalian Cell Cultures for Biologics Manufacturing & Bioreactors and Cell Culture Process Parameters
Week 7:	Bioreactor Operation Modes and Control & Cell Banking
Week 8:	Scale-Up and Scale-Down in Mammalian Cell Culture Processes
Week 9:	Downstream Process in Biopharmaceutical Productions
Week 10:	Using Quality by Design Principles in Setting a Control Strategy for Product Quality Attributes
Week 11:	Engineering Approach On Process Validation for Biopharmaceutical Productions
Week 12:	Case study: Cell Culture Processes for Monoclonal Antibody Production
Week 13:	Project Presentations
Week 14:	Project Presentations
Week 15*:	-
Week 16*:	Final Exam
Textbooks and materials:	Power point presentation files, related books and documents
Recommended readings:	1. M. L. Stacey and j. Davis, "Medicines from Animal Cell Culture", 2nd Edition, John Wiley&Sons, Ltd, England, 2007. 2. W. Zhou and A. Kantardjieff, “Mammalian Cel Cultures for Biologics Manufacturing”, Springer 3. Eibl R., Eibl D., Pörtner R., Catapano G. and Czermak P., 2009, Cell and Tissue Reaction Enginnering, Springer-Verlag Berlin Heidelberg Bates, R., 2005, Downstream Processing (Ch. 13), Cell Culture Technology for Pharmaceutical and Cell-Based Therapies, Ozturk, S. and Hu, W. S. (Eds.), CRC Press
	* Between 15th and 16th weeks is there a free week for students to prepare for final exam.

Assessment
Method of assessment	Week number	Weight (%)
Mid-terms:		0
Other in-term studies:		0
Project:	4-13	50
Homework:		0
Quiz:		0
Final exam:	16	50
	Total weight:	(%)

Workload
Activity	Duration (Hours per week)	Total number of weeks	Total hours in term
Courses (Face-to-face teaching):	3	15
Own studies outside class:	1	12
Practice, Recitation:	3	4
Homework:	0	0
Term project:	10	3
Term project presentation:	3	2
Quiz:	0	0
Own study for mid-term exam:	0	0
Mid-term:	0	0
Personal studies for final exam:	3	4
Final exam:	3	1
		Total workload:
		Total ECTS credits:	*
	* ECTS credit is calculated by dividing total workload by 25. (1 ECTS = 25 work hours)