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Information
| Code | BTE0056 |
| Name | Biotechnological Drugs, Production Methods and R&D Strategies |
| Term | 2023-2024 Academic Year |
| Semester | . Semester |
| Duration (T+A) | 3-0 (T-A) (17 Week) |
| ECTS | 6 ECTS |
| National Credit | 3 National Credit |
| Teaching Language | Türkçe |
| Level | Yüksek Lisans Dersi |
| Type | Normal |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator |
Course Goal / Objective
Within the scope of this course, it was aimed to teach definition of biotechnological drugs, in vitro and in vivo production methods, classification; erythropoietins, cancer antibodies, anti-TNF-drugs, insulin, coagulation factors, interferons, interleukins, hematopoietic growth factor, enzyme supplements, antiviral antibodies, follicle stimulating hormones, usage areas of biotechnological drugs, comparison with traditional drugs, enzymes used in biotechnological drug studies, It is aimed to teach hormones, antibodies, recombinant DNA technology, biotechnological drug production stages, monoclonal antibody production with hybridoma technology. Also, it was aimed to teachn isolation and purification techniques of biotechnological drugs, analytical methods; high pressure liquid chromatography (HPLC), mass spectrometry (MS), polyacrylamide gel electrophoresis (SDSPAGE), biotechnological product bioassays, in vivo experiments, in vitro experiments (Isolated organ experiments, primary cell culture experiments, constantly growing cell line experiments) biotechnological medicine storage, advantages and difficulties encountered in obtaining biotechnological medicines, comparability in biosimilar medicines, risk management, pharmacovigilance, medical application examples in biotechnological medicines, approval processes and global regulations for biotechnological drugs and biotech medicine R&D strategies.
Course Content
Definition of biotechnological drugs, in vitro and in vivo production methods, classification; erythropoietins, cancer antibodies, anti-TNF-drugs, insulin, coagulation factors, interferons, interleukins, hematopoietic growth factor, enzyme supplements, antiviral antibodies, follicle stimulating hormones, usage areas of biotechnological drugs, comparison with traditional drugs, enzymes used in biotechnological drug studies, hormones, antibodies, recombinant DNA technology, biotechnological drug production stages, monoclonal antibody production with hybridoma technology, isolation and purification techniques of biotechnological drugs, analytical methods; high pressure liquid chromatography (HPLC), mass spectrometry (MS), polyacrylamide gel electrophoresis (SDSPAGE), biotechnological product bioassays, in vivo experiments, in vitro experiments (Isolated organ experiments, primary cell culture experiments, constantly growing cell line experiments) , biotechnological drug storage, advantages and difficulties in obtaining biotechnological drugs, comparability in biosimilar drugs, risk management, pharmacovigilance, medical application examples in biotechnological drugs, approval processes and global regulations for biotechnological drugs, biotech drug R&D strategies.
Course Precondition
No Prerequisites
Resources
1. Akash MSH, Rehman K, Irshad K, Chen S. Pharmaceutical Biotechnology in Drug Development, Elsevier, 2023. 2. Crommelin DJA (Editor), Sindelar RD (Editor). Pharmaceutical Biotechnology: Fundamentals and Applications, Springer, 2013
Notes
Scientific database
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | Student defines biotechnological drugs, knows and explains in vitro and in vivo production methods and classification. |
| LO02 | Tells the biotechnological drug production stages |
| LO03 | Knows and explains the isolation and purification techniques and analytical methods of biotechnological drugs. |
| LO04 | Knows and explains biotechnological drug R&D strategies. |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | Bilgi - Kuramsal, Olgusal | Based on the undergraduate level qualifications, develops and deepens the knowledge in the same or different field at the level of expertise and analyzes and interprets them using statistical methods. | 4 |
| PLO02 | Beceriler - Bilişsel, Uygulamalı | To identifiy the interdisciplinary interaction of the field and to solve use of the methods. | 3 |
| PLO03 | Beceriler - Bilişsel, Uygulamalı | Interpret the knowledge gained in the field by integrating the information from different disciplines and creates new information | 3 |
| PLO04 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Develops new strategic approaches for solving complex problems that are encountered in applications related to the field. | 4 |
| PLO05 | Yetkinlikler - Öğrenme Yetkinliği | To teach the social, scientific, cultural and ethical values during the collection, interpretation, implementation and announcement of the data related to the field. | 3 |
| PLO06 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | To solve the problems encountered in the field and cominicate by using research methods. | 3 |
| PLO07 | Yetkinlikler - Alana Özgü Yetkinlik | To gain the ability to develop and deepen the knowledge in the field of biotechnology | |
| PLO08 | Bilgi - Kuramsal, Olgusal | Knows the ethical rules to be considered while obtaining biotechnological products. | |
| PLO09 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Establishes functional interaction by using strategic decision-making processes in solving the problems encountered in the field. | 5 |
| PLO10 | Yetkinlikler - Alana Özgü Yetkinlik | Gains the ability to develop and deepen their knowledge in the field of biotechnology at the level of expertise. | 3 |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | Definition of biotechnological drugs, in vitro and in vivo production methods | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 2 | Classification of biotechnological drugs, erythropoietins, cancer antibodies, antiTNF-drugs, insulin, coagulation factors, interferons, interleukins, hematopoietic growth factor, enzyme supplements, antiviral antibodies, follicle stimulating hormones | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 3 | Usage areas of biotechnological drugs, comparison with traditional drugs | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 4 | Enzymes, hormones, antibodies used in biotechnological drug studies | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 5 | Recombinant DNA technology | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 6 | Biotechnological drug production stages | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 7 | Monoclonal antibody production with hybridoma technology | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 8 | Isolation and purification techniques of biotechnological drugs | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 9 | Analytical methods; high pressure liquid chromatography (HPLC), mass spectrometry (MS) | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 10 | Polyacrylamide gel electrophoresis (SDSPAGE) | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 11 | Biotechnological product bioanalysis, in vivo experiments, in vitro experiments (isolated organ experiments, primary cell culture experiments, constantly growing cell line experiments) | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 12 | Storage of the biotechnological drug | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 13 | Advantages and difficulties of obtaining biotechnological drugs | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 14 | Comparability, risk management, pharmacovigilance in biosimilar drugs | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 15 | Approval processes, global regulations, R&D strategies and medical practice examples of biotechnological drugs | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 16 | Midterm exam | Ölçme Yöntemleri: Yazılı Sınav |
|
| 17 | Semester final exam | Ölçme Yöntemleri: Yazılı Sınav |
Student Workload - ECTS
| Works | Number | Time (Hour) | Workload (Hour) |
|---|---|---|---|
| Course Related Works | |||
| Class Time (Exam weeks are excluded) | 14 | 3 | 42 |
| Out of Class Study (Preliminary Work, Practice) | 14 | 5 | 70 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 0 | 0 | 0 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 15 | 15 |
| Final Exam | 1 | 30 | 30 |
| Total Workload (Hour) | 157 | ||
| Total Workload / 25 (h) | 6,28 | ||
| ECTS | 6 ECTS | ||