| Course Type | Elective Course |
|---|
| Course Level | Bachelor's Degree |
|---|
| Year of Study | - |
|---|
| Semester | - |
|---|
| ECTS | 2 |
|---|
| Name of Lecturer(s) |
|
| Learning Outcomes |
At the end of this course, the students;
- Learns the basic concepts in biotechnology, properties of biotechnological products.
- Learn about the production process of products produced with recombinant, monoclonal and hybridoma technology.
- Gains knowledge of the problems encountered in the formulations of biotechnological products and their solutions.
- Learns the processes of developing biosimilar products.
- Learn regulation of biosimilar products in the world and Turkey.
- Acquire knowledge about duties, rights and responsibilities; and act ethically and in compliance with regulations as an individual.
- Have knowledge about the ability to use the knowledge and skills gained in the advanced stages of education and to use them in professional life.
|
| Mode of Delivery | Face to face |
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| Prerequisites | No |
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| Recommended Optional Programme Components | None |
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| Course Description | This course covers the basic concepts in Pharmaceutical Biotechnology, the production processes of biotechnological products with recombinant DNA, monoclonal antibody and hybridoma technology, the production process and processes in the development of biosimilar products, and their legal regulations. |
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| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
Overview of Pharmaceutical Biotechnology: Properties and classifications of biotechnological products |
|
2nd Week |
Products produced with recombinant DNA technology, products approved by FDA and EMA |
|
3rd Week |
Products produced with monoclonal antibody and hybridoma technology, products approved by FDA and EMA |
|
4th Week |
Properties, physical and chemical stability of peptides and proteins |
|
5th Week |
Production processes of biotechnological products |
|
6th Week |
Formulations of biotechnological products |
|
7th Week |
MID TERM EXAMINATION |
|
8th Week |
Pharmacokinetics of biotechnological products |
|
9th Week |
Biotechnological vaccines (rDNA, mRNA vaccines) |
|
10th Week |
Biosimilar products; Definitions in terms of FDA, EMA, WHO and TITCK, The status of biosimilars in the world and Turkey |
|
11th Week |
Development of biosimilar products, production processes |
|
12th Week |
Comparability studies in the development of biosimilar products |
|
13th Week |
Legal regulations in biosimilar products |
|
14th Week |
Stability and storage of biotech products |
|
| Recommended or Required Reading | 1. Lecturer notes
2. Pharmaceutical Biotechnology. Ed: Daan JA Crommelin, Taylor&Francis Group, FL USA, 2002.
3. Protein Formulation and Delivery, Ed: J Eugene J Mc Nally, Taylor&Francis Group, FL USA 2007
4. Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications, Ed. Oliver Kayser, Wiley VCH , Germany 2012. |
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| Planned Learning Activities and Teaching Methods |
|
|---|
| Assessment Methods and Criteria |
|
Quantity |
Percentage (%) |
| Mid-term |
1 |
40 |
| Total(%) |
|
40 |
| Contribution of In-term Studies to Overall Grade(%) |
|
40 |
| Contribution of Final Examination to Overall Grade(%) |
|
60 |
| Total(%) |
|
100 |
|
| ECTS Allocated Based on Student Workload |
| Activities |
Quantity |
Duration (Hour) |
Total Workload (Hour) |
| Midterm exam |
1 |
2 |
2 |
| Preparation for Quiz |
0 |
0 |
0 |
| Individual or group work |
14 |
1 |
14 |
| Preparation for Final exam |
1 |
8 |
8 |
| Course hours |
14 |
2 |
28 |
| Preparation for Midterm exam |
1 |
6 |
6 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
2 |
2 |
| Homework |
1 |
5 |
5 |
| Total Work Load | 65 |
| Total Work Load / 30 (h) | 2.16 |
| ECTS Credit of the Course | 2 |
|
| Language of Instruction | Turkish |
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| Work Placement(s) | No |
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