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| MBGL5046 | Pharmaceutical Biotechnology | 3+0+0 | ECTS:7.5 | | Year / Semester | Fall Semester | | Level of Course | Second Cycle | | Status | Elective | | Department | DEPARTMENT of MOLECULAR BIOLOGY and GENETICS | | Prerequisites and co-requisites | None | | Mode of Delivery | | | Contact Hours | 14 weeks - 3 hours of lectures per week | | Lecturer | Dr. Öğr. Üyesi Uğur UZUNER | | Co-Lecturer | | | Language of instruction | | | Professional practise ( internship ) | None | | | | The aim of the course: | | To raise awareness among students about the latest developments in pharmaceutical biotechnology. Contribute to the follow-up of current research trends in the development of new fields of study and ideas. To raise awareness about the widespread use of vaccine development, recombinant value-added protein and monoclonal antibodies within the scope of pharmaceutical biotechnology. To increase the gains about the existence and effectiveness of targeted therapy samples. |
| Programme Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | PO - 1 : | Experience current and different approaches in pharmaceutical biotechnology | 2,3,5,9 | | | PO - 2 : | Adopts the relationships between molecular biology and the production of pharmaceuticals | 2,3,5,9 | | | PO - 3 : | understand the working mechanisms of molecular pharmaceuticals | 2,3,5,9 | | | CTPO : Contribution to programme outcomes, TOA :Type of assessment (1: written exam, 2: Oral exam, 3: Homework assignment, 4: Laboratory exercise/exam, 5: Seminar / presentation, 6: Term paper), PO : Learning Outcome | | |
| The course covers the molecular bases of protein therapeutics, analytical procedures for manufacturing, formulation development, pharmacokinetics and pharmacodynamics, immunogenicity, economic and practical issues of existing pharmaceuticals, and basic concepts and applications related to emerging new technologies. In the second chapter, the current stage of protein biology, various therapeutic classes of nucleotide and cell-based therapeutics is examined in detail. Monoclonal antibodies, CAR-T approaches, gene therapy, biosimilars and DNAs are some of the topics to be considered as recombinant pharmaceuticals. |
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| Course Syllabus | | Week | Subject | Related Notes / Files | | Week 1 | Molecular Biotechnology: From DNA Sequence to Therapeutic Protein | | | Week 2 | Biophysical and Biochemical Characteristics of Therapeutic Proteins | | | Week 3 | Protein Stability and Characterization | | | Week 4 | Production and Purification of Recombinant Proteins | | | Week 5 | Immunogenicity of Therapeutic Proteins | | | Week 6 | Monoclonal Antibodies: From Structure to Therapeutic Application | | | Week 7 | Regulatory Framework for Biosimilars | | | Week 8 | Mid Term | | | Week 9 | Vaccines | | | Week 10 | Oligonucleotides | | | Week 11 | Gene Therapy | | | Week 12 | Recombinant Coagulation Factors and Thrombolytic Agents | | | Week 13 | Monoclonal Antibodies in Cancer | | | Week 14 | Antibody-Based Biotherapeutics in Inflammatory Diseases | | | Week 15 | Student Seminar | | | Week 16 | Final Exam | | | |
| 1 | Daan J. A. Crommelin anf Robert D. Sindelar Bernd Meibohm. 2019. Pharmaceutical Biotechnology Fundamentals and Applications. 5th edition. Springer Nature Switzerland. ISBN 978-3-030-00709-6 | | | |
| 1 | Ana Catarina Silva; João Nuno Moreira; José Manuel Sousa Lobo; Hugo Almeida. 2020. Current Applications of Pharmaceutical Biotechnology Series. Springer International Publishing. ISBN: 9783030404642; 3030404641 | | | |
| Method of Assessment | | Type of assessment | Week No | Date | Duration (hours) | Weight (%) | | Mid-term exam | 8 | 17.11.2021 | 3 saat | 30 | | Presentation | 15 | 17.01.2022 | | 20 | | End-of-term exam | 16 | 27.01.2022 | | 50 | | |
| Student Work Load and its Distribution | | Type of work | Duration (hours pw) | No of weeks / Number of activity | Hours in total per term | | Yüz yüze eğitim | 3 | 14 | 42 | | Sınıf dışı çalışma | 3 | 14 | 42 | | Arasınav için hazırlık | 3 | 6 | 18 | | Arasınav | 3 | 1 | 3 | | Uygulama | 3 | 14 | 42 | | Ödev | 3 | 1 | 3 | | Proje | 3 | 3 | 9 | | Kısa sınav | 3 | 4 | 12 | | Dönem sonu sınavı için hazırlık | 3 | 6 | 18 | | Dönem sonu sınavı | 3 | 1 | 3 | | Total work load | | | 192 |
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