Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| BIOTECHNOLOGICAL PRODUCTS and BIOSIMILAR DRUGS | - | Spring Semester | 2+0 | 2 | 3 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Elective |
| Course Coordinator | Prof.Dr. Fatma Julide AKBUĞA |
| Name of Lecturer(s) | Prof.Dr. Fatma Julide AKBUĞA |
| Assistant(s) | |
| Aim | To give to the students recombinant DNA technology, biotechnological products and biosimilar drugs. |
| Course Content | This course contains; 1. Recombinant DNA technology and expression of genes in prokaryotic and eukaryotic cells,2. Recombinant DNA technology and production,3. Production of biotechnology-derived drugs,upstream process and cell banks,4. Production of biotechnological drugs:downstream process,bioreactors,5. Purification of biopharmaceuticals in protein structure, it’s characterization and preparation: Further purification by Ultrafiltration-Chromatography,6. Recombinant Biopharmaceuticals I: monoclonal antibodies, cytokines), Cell Culture,7. Recombinant Biopharmaceuticals II: insulin, therapeutic hormones, therapeutic enzymes and clotting-related drugs and erythropoietin,8. Targeting of recombinant protein and nucleic acid-based drugs, the pegylated technologies and advancements,9.Gene therapy and gen medicines,10. Biosimilar drugs,11. Biosimilar drugs,12.Cell therapy products,13.Blood Products,14. Biotechnological vaccines. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| At the end of this course, the students will be able to; | 19, 9 | A |
| 1. explained biotechnology and recombinant DNA technology. | 19, 9 | A |
| 1.1. define biotechnology. | 19, 9 | A |
| 1.2. tell the process of recombinant DNA technology. | 19, 9 | A |
| 2. categorized peptids and proteins that are biotechnological products. | 19, 9 | A |
| 2.1. tell the preparation of recombinant biopharmaceutics. | 19, 9 | A |
| 2.2. define the recombinant biopharmaceutics. | 19, 9 | A |
| 2.3. summarize the application of cell culture. | 19, 9 | A |
| 3. defined biosimilar drugs. | 19, 9 | A |
| 3.1. explain the licensing and patent requirement of biosimilar drugs. | 19, 9 | A |
| 3.2. tell the speciality of biosimilar drugs. | 19, 9 | A |
| 4. explained new development in biotechnological products and it’s safety and ethical issues. | 19, 9 | A |
| 4.1. identify the safety and ethic issues of biotechnological issues. | 19, 9 | A |
| 4.2. tell new development in biotechnological products. | 19, 9 | A |
| Teaching Methods: | 19: Brainstorming Technique, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | 1. Recombinant DNA technology and expression of genes in prokaryotic and eukaryotic cells | 1,2,3 |
| 2 | 2. Recombinant DNA technology and production | 1,2,3 |
| 3 | 3. Production of biotechnology-derived drugs,upstream process and cell banks | 1,2,3 |
| 4 | 4. Production of biotechnological drugs:downstream process,bioreactors | 1,2,3 |
| 5 | 5. Purification of biopharmaceuticals in protein structure, it’s characterization and preparation: Further purification by Ultrafiltration-Chromatography | 1,2,3 |
| 6 | 6. Recombinant Biopharmaceuticals I: monoclonal antibodies, cytokines), Cell Culture | 1,2,3 |
| 7 | 7. Recombinant Biopharmaceuticals II: insulin, therapeutic hormones, therapeutic enzymes and clotting-related drugs and erythropoietin | 1,2,3 |
| 8 | 8. Targeting of recombinant protein and nucleic acid-based drugs, the pegylated technologies and advancements | 1,2,3 |
| 9 | 9.Gene therapy and gen medicines | 1,2,3 |
| 10 | 10. Biosimilar drugs | 1,2,3 |
| 11 | 11. Biosimilar drugs | 1,2,3 |
| 12 | 12.Cell therapy products | 1,2,3 |
| 13 | 13.Blood Products | 1,2,3 |
| 14 | 14. Biotechnological vaccines | 1,2,3 |
| Resources |
| Lecture notes, powerpoint presentations, relevant web pages will be given to students. |
| -Walsh,G; BIOPHARMACEUTICALS BIOCHEMISTRY AND BIOTECHNOLOGY, WILEY,England -Daan J.A. Crommelin • Robert D. Sindelar Bernd Meibohm; Pharmaceutical Biotechnology, Springer New York Heidelberg Dordrecht London |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PQ-1. Skilfully use information technology to access, follow, evaluate and apply current knowledge in the field of Pharmaceutical Sciences. | ||||||
| 2 | PQ-2. Have advanced knowledge in APIs and DPs. | ||||||
| 3 | PQ-3. Collaborate with the experts for collection, interpretation, application and declaration of data in Pharmaceutical Sciences field. | ||||||
| 4 | PQ-4. Provide best patient counseling services and medication therapy management using his/her knowledge and pharmaceutical information systems to improve the quality of life and safety of patient. | ||||||
| 5 | PQ-5. Capable of organizing and administering a drugstore as per responsibilities prescribed under the Pharmacy Law, using skills, knowledge and advanced technology systems. | ||||||
| 6 | PQ-6. Skilfully use computer programs and advanced technology related to the Pharmaceutical Sciences. | ||||||
| 7 | PQ-7. Provide solutions to the professional issues using scientific knowledge and data. | ||||||
| 8 | PQ-8. Perform identification, quality control and standardization of the drug products. | ||||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | ||||||
| 10 | PQ-10. Capable of conducting independent studies with his/her advanced knowledge in pharmaceutical sciences, takes responsibilities in professional organizations and efficiently collaborates with the members of his/her own organization as well as other organizations. | ||||||
| 11 | PQ-11. Clearly show signs of adoption of life-long learning and openness to further development. | ||||||
| 12 | PQ-12. Critically evaluate their knowledge in pharmaceutical sciences. | ||||||
| 13 | PQ-13. Closely follow and evaluate the national and international professional developments. | ||||||
| 14 | PQ-14. Record and document all professional activities and applications. | ||||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | ||||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | ||||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | ||||||
| 18 | PQ-18. Actively involve in the preparation of APIs, every stage of the formulation and production of DPs. | ||||||
| 19 | PQ-19. Knowledgable in the regulatory rules of new drug application, data protection and patent issues and understand their interrelationship. | ||||||
| 20 | PQ-20. Have awareness of his/her duties, rights and responsibilities and act based on Pharmacy Law and high professional ethical standards. | ||||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | ||||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |
| ECTS / Workload Table | ||||||
| Activities | Number of | Duration(Hour) | Total Workload(Hour) | |||
| Course Hours | 0 | 0 | 0 | |||
| Guided Problem Solving | 0 | 0 | 0 | |||
| Resolution of Homework Problems and Submission as a Report | 0 | 0 | 0 | |||
| Term Project | 0 | 0 | 0 | |||
| Presentation of Project / Seminar | 0 | 0 | 0 | |||
| Quiz | 0 | 0 | 0 | |||
| Midterm Exam | 0 | 0 | 0 | |||
| General Exam | 0 | 0 | 0 | |||
| Performance Task, Maintenance Plan | 0 | 0 | 0 | |||
| Total Workload(Hour) | 0 | |||||
| Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(0/30) | 0 | |||||
| ECTS of the course: 30 hours of work is counted as 1 ECTS credit. | ||||||
Detail Informations of the Course
Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| BIOTECHNOLOGICAL PRODUCTS and BIOSIMILAR DRUGS | - | Spring Semester | 2+0 | 2 | 3 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Elective |
| Course Coordinator | Prof.Dr. Fatma Julide AKBUĞA |
| Name of Lecturer(s) | Prof.Dr. Fatma Julide AKBUĞA |
| Assistant(s) | |
| Aim | To give to the students recombinant DNA technology, biotechnological products and biosimilar drugs. |
| Course Content | This course contains; 1. Recombinant DNA technology and expression of genes in prokaryotic and eukaryotic cells,2. Recombinant DNA technology and production,3. Production of biotechnology-derived drugs,upstream process and cell banks,4. Production of biotechnological drugs:downstream process,bioreactors,5. Purification of biopharmaceuticals in protein structure, it’s characterization and preparation: Further purification by Ultrafiltration-Chromatography,6. Recombinant Biopharmaceuticals I: monoclonal antibodies, cytokines), Cell Culture,7. Recombinant Biopharmaceuticals II: insulin, therapeutic hormones, therapeutic enzymes and clotting-related drugs and erythropoietin,8. Targeting of recombinant protein and nucleic acid-based drugs, the pegylated technologies and advancements,9.Gene therapy and gen medicines,10. Biosimilar drugs,11. Biosimilar drugs,12.Cell therapy products,13.Blood Products,14. Biotechnological vaccines. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| At the end of this course, the students will be able to; | 19, 9 | A |
| 1. explained biotechnology and recombinant DNA technology. | 19, 9 | A |
| 1.1. define biotechnology. | 19, 9 | A |
| 1.2. tell the process of recombinant DNA technology. | 19, 9 | A |
| 2. categorized peptids and proteins that are biotechnological products. | 19, 9 | A |
| 2.1. tell the preparation of recombinant biopharmaceutics. | 19, 9 | A |
| 2.2. define the recombinant biopharmaceutics. | 19, 9 | A |
| 2.3. summarize the application of cell culture. | 19, 9 | A |
| 3. defined biosimilar drugs. | 19, 9 | A |
| 3.1. explain the licensing and patent requirement of biosimilar drugs. | 19, 9 | A |
| 3.2. tell the speciality of biosimilar drugs. | 19, 9 | A |
| 4. explained new development in biotechnological products and it’s safety and ethical issues. | 19, 9 | A |
| 4.1. identify the safety and ethic issues of biotechnological issues. | 19, 9 | A |
| 4.2. tell new development in biotechnological products. | 19, 9 | A |
| Teaching Methods: | 19: Brainstorming Technique, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | 1. Recombinant DNA technology and expression of genes in prokaryotic and eukaryotic cells | 1,2,3 |
| 2 | 2. Recombinant DNA technology and production | 1,2,3 |
| 3 | 3. Production of biotechnology-derived drugs,upstream process and cell banks | 1,2,3 |
| 4 | 4. Production of biotechnological drugs:downstream process,bioreactors | 1,2,3 |
| 5 | 5. Purification of biopharmaceuticals in protein structure, it’s characterization and preparation: Further purification by Ultrafiltration-Chromatography | 1,2,3 |
| 6 | 6. Recombinant Biopharmaceuticals I: monoclonal antibodies, cytokines), Cell Culture | 1,2,3 |
| 7 | 7. Recombinant Biopharmaceuticals II: insulin, therapeutic hormones, therapeutic enzymes and clotting-related drugs and erythropoietin | 1,2,3 |
| 8 | 8. Targeting of recombinant protein and nucleic acid-based drugs, the pegylated technologies and advancements | 1,2,3 |
| 9 | 9.Gene therapy and gen medicines | 1,2,3 |
| 10 | 10. Biosimilar drugs | 1,2,3 |
| 11 | 11. Biosimilar drugs | 1,2,3 |
| 12 | 12.Cell therapy products | 1,2,3 |
| 13 | 13.Blood Products | 1,2,3 |
| 14 | 14. Biotechnological vaccines | 1,2,3 |
| Resources |
| Lecture notes, powerpoint presentations, relevant web pages will be given to students. |
| -Walsh,G; BIOPHARMACEUTICALS BIOCHEMISTRY AND BIOTECHNOLOGY, WILEY,England -Daan J.A. Crommelin • Robert D. Sindelar Bernd Meibohm; Pharmaceutical Biotechnology, Springer New York Heidelberg Dordrecht London |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PQ-1. Skilfully use information technology to access, follow, evaluate and apply current knowledge in the field of Pharmaceutical Sciences. | ||||||
| 2 | PQ-2. Have advanced knowledge in APIs and DPs. | ||||||
| 3 | PQ-3. Collaborate with the experts for collection, interpretation, application and declaration of data in Pharmaceutical Sciences field. | ||||||
| 4 | PQ-4. Provide best patient counseling services and medication therapy management using his/her knowledge and pharmaceutical information systems to improve the quality of life and safety of patient. | ||||||
| 5 | PQ-5. Capable of organizing and administering a drugstore as per responsibilities prescribed under the Pharmacy Law, using skills, knowledge and advanced technology systems. | ||||||
| 6 | PQ-6. Skilfully use computer programs and advanced technology related to the Pharmaceutical Sciences. | ||||||
| 7 | PQ-7. Provide solutions to the professional issues using scientific knowledge and data. | ||||||
| 8 | PQ-8. Perform identification, quality control and standardization of the drug products. | ||||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | ||||||
| 10 | PQ-10. Capable of conducting independent studies with his/her advanced knowledge in pharmaceutical sciences, takes responsibilities in professional organizations and efficiently collaborates with the members of his/her own organization as well as other organizations. | ||||||
| 11 | PQ-11. Clearly show signs of adoption of life-long learning and openness to further development. | ||||||
| 12 | PQ-12. Critically evaluate their knowledge in pharmaceutical sciences. | ||||||
| 13 | PQ-13. Closely follow and evaluate the national and international professional developments. | ||||||
| 14 | PQ-14. Record and document all professional activities and applications. | ||||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | ||||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | ||||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | ||||||
| 18 | PQ-18. Actively involve in the preparation of APIs, every stage of the formulation and production of DPs. | ||||||
| 19 | PQ-19. Knowledgable in the regulatory rules of new drug application, data protection and patent issues and understand their interrelationship. | ||||||
| 20 | PQ-20. Have awareness of his/her duties, rights and responsibilities and act based on Pharmacy Law and high professional ethical standards. | ||||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | ||||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |