Pharmaceutical and Medical Biotechnology

Data

Official data in SubjectManager for the following academic year: 2024-2025

Course director

  • Pongrácz Judit Erzsébet

    professor,
    Faculty of Health Sciences - Institute of Health Science, Department of Public Health

Number of hours/semester

lectures: 28 hours

practices: 28 hours

seminars: 14 hours

total of: 70 hours

Subject data

  • Code of subject: OTM-PMBT-T
  • 7 kredit
  • Biotechnology BSc
  • Specialty Module in Biotechnology modul
  • autumn
Prerequisites:

OTV-IBI1-T finished , OTM-MAND-T finished , OTM-MGT1-T finished

Course headcount limitations

min. 5 – max. 50

Topic

The course provides insight into opportunities of pharmaceutical and medical biotechnology development for industrial use. The course encompasses the latest development in diagnostic and therapeutic production. Students will familiarize with stem cell isolation, induced pluripotent stem cell engineering, their experimental and therapeutic use. During seminars and practices the students will observe and assay tissue printing. They will also have insight into modern developmental procedures of drug development (vaccine production, therapeutic cytokines, monoclonal antibodies). Lectures will discuss the development and production of advanced therapeutic medicinal products. Practices will give the opportunity to try every step in ATMP design and manufacture. Knowledge gathered during the course has key importance in understanding future therapeutics options, and also provides advantage on the labor-market.

Lectures

  • 6. Disease backgrounds - research approaches II. - Pongrácz Judit Erzsébet
  • 5. Disease backgrounds - research approaches I. - Pongrácz Judit Erzsébet
  • 4. Difference between diagnostic markers and drug targets II. - Pongrácz Judit Erzsébet
  • 3. Difference between diagnostic markers and drug targets I. - Pongrácz Judit Erzsébet
  • 2. Biotechnology in pharmacy and medicine II. - Pongrácz Judit Erzsébet
  • 1. Biotechnology in pharmacy and medicine I. - Pongrácz Judit Erzsébet
  • 7. Disease backgrounds - research approaches III. - Pongrácz Judit Erzsébet
  • 8. Disease backgrounds - research approaches IV. - Pongrácz Judit Erzsébet
  • 9. Diagnostic markers - research approaches I. - Pongrácz Judit Erzsébet
  • 10. Diagnostic markers - research approaches II. - Pongrácz Judit Erzsébet
  • 11. Diagnostic markers - research approaches III. - Pongrácz Judit Erzsébet
  • 12. Diagnostic markers - research approaches IV. - Pongrácz Judit Erzsébet
  • 13. Manipulation of the genome for monoclonal antibody production I. - Pongrácz Judit Erzsébet
  • 14. Manipulation of the genome for monoclonal antibody production II. - Pongrácz Judit Erzsébet
  • 15. Manipulation of the genome for effector immune cell production I. - Pongrácz Judit Erzsébet
  • 16. Manipulation of the genome for effector immune cell production II. - Pongrácz Judit Erzsébet
  • 17. Manipulation of the genome for effector immune cell production III. - Pongrácz Judit Erzsébet
  • 18. Manipulation of the genome for effector immune cell production IV. - Pongrácz Judit Erzsébet
  • 19. Disease prevention - vaccine production using biotechnology I. - Pongrácz Judit Erzsébet
  • 20. Disease prevention - vaccine production using biotechnology II. - Pongrácz Judit Erzsébet
  • 21. Complex tissues in therapy - biotechnology in surgery I. - Pongrácz Judit Erzsébet
  • 22. Complex tissues in therapy - biotechnology in surgery II. - Pongrácz Judit Erzsébet
  • 23. Regulation of biotechnology (FDA, EMA and local law) to product development and clinical trials I. - Pongrácz Judit Erzsébet
  • 24. Regulation of biotechnology (FDA, EMA and local law) to product development and clinical trials II. - Pongrácz Judit Erzsébet
  • 25. Regulation of biotechnology (FDA, EMA and local law) to product development and clinical trials III. - Pongrácz Judit Erzsébet
  • 26. Regulation of biotechnology (FDA, EMA and local law) to product development and clinical trials IV. - Pongrácz Judit Erzsébet
  • 27. Regulation of biotechnology (FDA, EMA and local law) to product development and clinical trials V. - Pongrácz Judit Erzsébet
  • 28. Regulation of biotechnology (FDA, EMA and local law) to product development and clinical trials VI. - Pongrácz Judit Erzsébet

Practices

  • 6. Comparative analysis of healthy and diseased cells - research approaches II. - Papp Alexandra
  • 5. Comparative analysis of healthy and diseased cells - research approaches I. - Papp Alexandra
  • 4. Using public databases for sequence and plasmid design - Steinerbrunnerné Nagy Alexandra
  • ...
  • 3. Using public databases for sequence and plasmid design - Steinerbrunnerné Nagy Alexandra
  • 2. Using public databases for sequence and plasmid design - Steinerbrunnerné Nagy Alexandra
  • 1. Using public databases for sequence and plasmid design - Steinerbrunnerné Nagy Alexandra
  • 7. Comparative analysis of healthy and diseased cells - research approaches III. - Papp Alexandra
  • 8. Comparative analysis of healthy and diseased cells - research approaches IV. - Papp Alexandra
  • 9. Analysis of laboratory data and proposal for diagnostic markers - research approaches I. - Ádám Zoltán Mihály
  • 10. Analysis of laboratory data and proposal for diagnostic markers - research approaches II. - Ádám Zoltán Mihály
  • 11. Analysis of laboratory data and proposal for diagnostic markers - research approaches III. - Ádám Zoltán Mihály
  • 12. Analysis of laboratory data and proposal for diagnostic markers - research approaches IV. - Ádám Zoltán Mihály
  • 13. Using target specific monoclonal antibodies in laboratory treatment I. - Ádám Zoltán Mihály
  • 14. Using target specific monoclonal antibodies in laboratory treatment II. - Ádám Zoltán Mihály
  • 15. Using target specific monoclonal antibodies in laboratory treatment III. - Papp Alexandra
  • 16. Using target specific monoclonal antibodies in laboratory treatment IV. - Papp Alexandra
  • 17. Plazmid-receptor design and test for effector immune cells I. - Steinerbrunnerné Nagy Alexandra
  • 18. Plazmid-receptor design and test for effector immune cells II. - Steinerbrunnerné Nagy Alexandra
  • 19. Plazmid-receptor design and test for effector immune cells III. - Steinerbrunnerné Nagy Alexandra
  • 20. Plazmid-receptor design and test for effector immune cells IV. - Steinerbrunnerné Nagy Alexandra
  • 21. Culturing mesenchymal stem cells - I. - Steinerbrunnerné Nagy Alexandra
  • 22. Culturing mesenchymal stem cells - I. - Steinerbrunnerné Nagy Alexandra
  • 23. Detection of mesenchymal stem cell markers - I. - Ádám Zoltán Mihály
  • 24. Detection of mesenchymal stem cell markers - I. - Ádám Zoltán Mihály
  • 25. Regulation of biotechnology (FDA, EMA and local law) to product development and clinical trials - case study I. - Ádám Zoltán Mihály
  • 26. Regulation of biotechnology (FDA, EMA and local law) to product development and clinical trials - case study I. - Ádám Zoltán Mihály
  • 27. Regulation of biotechnology (FDA, EMA and local law) to product development and clinical trials - case study II. - Ádám Zoltán Mihály
  • 28. Regulation of biotechnology (FDA, EMA and local law) to product development and clinical trials - case study II. - Ádám Zoltán Mihály

Seminars

  • 4. Databases - how to use them? - Garai Kitti
  • ...
  • 3. Databases - how to use them? - Garai Kitti
  • 2. Databases - how to use them? - Garai Kitti
  • 1. Databases - how to use them? - Garai Kitti
  • 5. Analysis of database and research lab data for pharmaceutical or clinical application - Garai Kitti
  • 6. Analysis of database and research lab data for pharmaceutical or clinical application - Garai Kitti
  • 7. Midterm test - Garai Kitti
  • 8. Plasmid design with specific diagnostic and therapeutic targets - Garai Kitti
  • 9. Plasmid design with specific diagnostic and therapeutic targets - Ádám Zoltán Mihály
  • 10. Plasmid design with specific diagnostic and therapeutic targets - Ádám Zoltán Mihály
  • 11. Preparation of documentation for ethical committees - Ádám Zoltán Mihály
  • 12. Preparation of documentation for ethical committees II. - Ádám Zoltán Mihály
  • 13. Preparation of documentation for clinical trials - Ádám Zoltán Mihály
  • 14. Preparation of documentation for clinical trials II. - Ádám Zoltán Mihály

Reading material

Obligatory literature

Literature developed by the Department

Lecture ppt, interactive materials on seminars and practice lab notes

Notes

Recommended literature

1.Medical Biotechnology Ed. J. Pongracz, M. Keen, 2009, Elsevier; ISBN 978-0-08-045135-0

2.Pharmaceutical Biotechnology, Gary Walsh, 2007, Wiley; ISBN: 978-0-470-01244-4

3.DJA Crommelin: Pharmaceutical Biotechnology: Fundamentals and Applications, Springer, ISBN-13: 978-3030007096, ISBN-10: 303000709X

Conditions for acceptance of the semester

Attendance to 75% of lectures and seminars

Mid-term exams

One midterm test, if unsuccessful the test can be repeated twice more.

Making up for missed classes

None

Exam topics/questions

Teams, Neptun

Examiners

  • Garai Kitti
  • Pongrácz Judit Erzsébet

Instructor / tutor of practices and seminars

  • Ádám Zoltán Mihály
  • Garai Kitti
  • Papp Alexandra
  • Steinerbrunnerné Nagy Alexandra