COURSE UNIT TITLE

: MOLECULAR AND CELLULAR BIOTECHNOLOGY

DEGREE PROGRAMMES

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
MBG 6125 MOLECULAR AND CELLULAR BIOTECHNOLOGY ELECTIVE 2 2 0 12

Offered By

Molecular Biology and Genetics

Level of Course Unit

Third Cycle Programmes (Doctorate Degree)

Course Coordinator

ASSISTANT PROFESSOR MUHAMMED KASIM DIRIL

Offered to

Molecular Biology and Genetics

Course Objective

To introduce the students about the industrial pharmaceutical biotechnology, biopharmaceutical development processes, regulations and drug characterizations using analytical methods and presumptions of therapeutic equivalence along with case studies.

Learning Outcomes of the Course Unit

1   Describe the current expression systems, and manufacturing processes and analytical methodsusedin pharmaceutical biotechnology.
2   Outline the importance of the roles of quality control, quality assurance and validation for achieving the final product within the framework of regulations, biotechnological aspects and ethics.
3   Outline the requirements of process design, scale-up and management.
4   Determine proper source, production, purification and characterization method(s) of biopharmaceuticals.
5   Give information about biochemistry, production, therapeutic and clinical applications of selected biopharmaceuticals.

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description
1 Introduction to biopharmaceutical products
2 Regulations, authorities, quality assurance and GMP
3 Expression systems for production of biopharmaceuticals
4 Overview of production process and analytical technology
5 Fermentation, product recovery, concentration and chromatographic purification
6 Consistency of scale-up from bioprocess development to production
7 Therapeutic proteinstability and formulation
8 Quality and risk management in ensuring the virus safety of biopharmaceuticals
9 Midterm
10 Advances in process development: Affinity chromatography, hydroxyapatite, monoliths and membrane chromatography
11 Advances in process development: Biosensors in the processing and analysis of biopharmaceuticals
12 Advances in process development: Applications of proteomics toolkit in protein biological production and method development
13 Biopharmaceutical validation
14 Therapeutic and clinical applications of biopharmaceuticals
15 Biochemistry, production and clinical use of certain biopharmaceuticals
16 Final Exam

Recomended or Required Reading

Textbook(s): Subramanian, G. (2012). Biopharmaceutical Production Technology, 2 Volume Set (Vol. 1). John Wiley & Sons.
Supplementary Book(s):Ho, R. J., &Gibaldi, M. (2004). Biotechnology and biopharmaceuticals: transforming proteins and genes into drugs. John Wiley & Sons.

Planned Learning Activities and Teaching Methods

1. Presentation
2. Interactive narrative
3. Question-answertechnique
4. Homework

Assessment Methods

Successful / Unsuccessful


*** Resit Exam is Not Administered in Institutions Where Resit is not Applicable.

Further Notes About Assessment Methods

None

Assessment Criteria

Meaningful learning of the basic concepts given in presentations, association of concepts with each other, establishing the cause-result relationships and making comments by using the information available for problems and evaluating idea generation are carried out with mid-term and final exams, active participation to the lecture, homework.

Language of Instruction

English

Course Policies and Rules

To be announced.

Contact Details for the Lecturer(s)

kasim.diril@deu.edu.tr

Office Hours

Friday 13.30-15.00

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
Lectures 14 3 42
Preparations before/after weekly lectures 14 7 98
Preparation for midterm exam 1 25 25
Preparation for final exam 1 30 30
Preparing assignments 5 8 40
Preparing assignments 2 8 16
Preparing presentations 3 15 45
Final 1 2 2
Midterm 1 2 2
TOTAL WORKLOAD (hours) 300

Contribution of Learning Outcomes to Programme Outcomes

PO/LOPO.1PO.2PO.3PO.4PO.5PO.6PO.7PO.8
LO.13
LO.23
LO.33
LO.43
LO.53

CONTACT INFORMATION
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Phone: +90(232) 412 12 12 - Fax: +90 (232) 464 81 35

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