BTE0056 Biotechnological Drugs, Production Methods and R&D Strategies

6 ECTS - 3-0 Duration (T+A)- . Semester- 3 National Credit

Information

Code BTE0056
Name Biotechnological Drugs, Production Methods and R&D Strategies
Term 2024-2025 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 Kitap ve bilimsel veri tabanları 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 Term Exams 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

Update Time: 20.05.2024 03:07