BTE0053 Biosimilar Medicines and Biotechnology

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

Information

Code BTE0053
Name Biosimilar Medicines and Biotechnology
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 İngilizce
Level Doktora Dersi
Type Normal
Mode of study Yüz Yüze Öğretim
Catalog Information Coordinator Prof. Dr. NACİYE DÖNDAŞ


Course Goal / Objective

Within the scope of this course, it was aimed to teach definition of biosimilar drugs, differences between biotechnological reference medicine and biosimilar medicine, in vitro and in vivo production methods of biosimilars and recombinant DNA technology, comparison studies of biosimilars with reference biotechnological drugs; safety, efficacy, quality profiles, the effect of atypical glycosylation pattern in biosimilars on pharmacokinetic, pharmacodynamic and immunogenicity parameters, risk factors, pharmacovigilance, isolation and purification techniques of biosimilars, biosimilar product bioanalysis, analytical methods; high-pressure liquid chromatography (HPLC), mass spectrometry (MS), polyacrylamide gel electrophoresis (SDS-PAGE), medical application examples in biosimilar drugs, approval processes and global regulations of biosimilar drugs, and biosimilar drug R&D strategies.

Course Content

Definition of biosimilar drugs, differences between biotechnological reference medicine and biosimilar medicine, in vitro and in vivo production methods of biosimilars and recombinant DNA technology, comparison studies of biosimilars with reference biotechnological drugs; safety, efficacy, quality profiles, the effect of atypical glycosylation pattern in biosimilars on pharmacokinetic, pharmacodynamic and immunogenicity parameters, risk factors, pharmacovigilance, isolation and purification techniques of biosimilars, biosimilar product bioanalysis, analytical methods; high pressure liquid chromatography (HPLC), mass spectrometry (MS), polyacrylamide gel electrophoresis (SDS-PAGE), medical application examples in biosimilars, approval processes and global regulations of biosimilars, biosimilar drug R&D strategies.

Course Precondition

No Prerequisites

Resources

1. Feng X, Xie HG, Malhotra A, Yang CF. Biologics and Biosimilars Drug Discovery and Clinical Applications, CRC Press, 2022 2. Endrenyi L, Chow SC, Paul Declerck P. Biosimilar Drug Product Development, CRC Press, 2017.

Notes

Scientific database


Course Learning Outcomes

Order Course Learning Outcomes
LO01 The student knows and explains the differences between a biotechnological reference drug and a biosimilar drug.
LO02 Comparison studies of a biosimilar drug with a reference biotechnological drug; Knows and applies methods and techniques
LO03 Knows and explains examples of medical applications in biosimilar drugs
LO04 Know and explain biosimilar drugs approval processes and global regulations, biosimilar drug R&D strategies


Relation with Program Learning Outcome

Order Type Program Learning Outcomes Level
PLO01 Bilgi - Kuramsal, Olgusal Develop and deepen the current and advanced knowledge in the field with original thought and / or research at the level of expertise based on the qualifications of the graduate and reach the original definitions that will bring innovation to the field. 3
PLO02 Bilgi - Kuramsal, Olgusal Understands the interdisciplinary interaction of the field; it achieves original results using knowledge requiring expertise in analysis, synthesis and evaluation of new and complex ideas. 3
PLO03 Beceriler - Bilişsel, Uygulamalı Evaluates, uses and transfers new information in the field with a systematic approach. 3
PLO04 Beceriler - Bilişsel, Uygulamalı Makes critical analysis, synthesis and evaluation of new and complex thoughts. 3
PLO05 Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği Makes leadership in environments that require the analysis of original and interdisciplinary problems. 3
PLO06 Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği It extends the limits of knowledge in its field by publishing at least one scientific article in its field in national and / or international refereed journals and / or producing or interpreting an original work. 4
PLO07 Yetkinlikler - Öğrenme Yetkinliği Develops new ideas and methods related to the field by using high level mental processes such as creative and critical thinking, problem solving and decision making.
PLO08 Yetkinlikler - İletişim ve Sosyal Yetkinlik He / she defends his / her original opinions in discussing the subjects in his / her field and establishes an effective communication showing his / her competence in the field.
PLO09 Yetkinlikler - Alana Özgü Yetkinlik Conducts scientific research in national and international scientific research groups. 5
PLO10 Yetkinlikler - Alana Özgü Yetkinlik Establishes functional interaction by using strategic decision making processes in solving problems encountered in the field. 3


Week Plan

Week Topic Preparation Methods
1 Definition of biosimilar drugs, differences between biotechnological reference drug and biosimilar drug Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
2 In vitro and in vivo production methods of biosimilar drugs and recombinant DNA technology Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
3 Comparison studies of biosimilar drug with reference biotechnological drug; safety, efficacy, quality profiles Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
4 Effect of atypical glycosylation pattern in biosimilar drugs on pharmacokinetic, pharmacodynamic and immunogenicity parameters Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
5 Risk factors in biosimilar drugs, pharmacovigilance Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
6 Isolation and purification techniques of biosimilar drugs Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
7 Biosimilar product bioanalysis Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
8 Analytical methods; Polyacrylamide gel electrophoresis (SDSPAGE) Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
9 high pressure liquid chromatography (HPLC) Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
10 Mass spectrometry (MS) Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
11 Polyacrylamide gel electrophoresis (SDS-PAGE) Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
12 Examples of medical applications in biosimilar drugs Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
13 Approval processes and global regulations for biosimilar drugs Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
14 Biosimilar drug R&D strategies-1 Books and scientific databases Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
15 Biosimilar drug R&D strategies-2 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

Update Time: 14.05.2024 05:06