Pharmaceutical Technology

Adatok

A Tantárgybejelentőben megadott hivatalos adatok az alábbi tanévre: 2026-2027

Tematika

This course provides a comprehensive, process-oriented transition from molecular biotechnology to industrial-scale medicine production, emphasizing the “molecule’s journey” from cellular expression to the final dosage form. The curriculum integrates upstream and downstream bioprocessing with advanced formulation science, enabling students to understand the critical interdependence between manufacturing parameters, product safety, and therapeutic efficacy. Through a Quality by Design (QbD) and decision-focused framework, the course highlights the central role of Good Manufacturing Practice (GMP), viral safety, protein stability, and regulatory compliance in the development of safe, reliable, and affordable healthcare solutions.

Students engage with complex technological decision-making processes, including resource-efficient purification strategies, sterilization technologies, nanomedicine formulation, and biosimilar development. By combining industrial biotechnology, sustainable manufacturing practices, and regulatory science, the course fosters an analytical and systems-oriented mindset required for high-level quality decision-making in regulated biopharmaceutical environments. Ultimately, it prepares biotechnology students to contribute to sustainable, resilient, and globally accessible medicinal product development.

Előadások

• 1. Introduction to pharmaceutical technology: basic terms (API, excipients) and biopharmaceutical classification (BCS, LADME) - Pál Szilárd
• 2. Introduction to pharmaceutical technology: basic terms (API, excipients) and biopharmaceutical classification (BCS, LADME) - Pál Szilárd
• 3. Upstream processes: Engineered cells, culture media and fermentation technologies - Lemli Beáta
• 4. Upstream processes: Engineered cells, culture media and fermentation technologies - Lemli Beáta
• 5. Downstream processes I: Harvest, primary isolation and removal of particulates - Lemli Beáta
• 6. Downstream processes I: Harvest, primary isolation and removal of particulates - Lemli Beáta
• 7. Downstream processes II: Purification strategies, chromatography and final product isolation - Lemli Beáta
• 8. Downstream processes II: Purification strategies, chromatography and final product isolation - Lemli Beáta
• 9. Pharmaceutical industrial plant: GMP, qualification, validation and safety - Lemli Beáta
• 10. Pharmaceutical industrial plant: GMP, qualification, validation and safety - Lemli Beáta
• 11. Introduction to aseptic preparation: methods of sterilization, pyrogens and viral safety - Lemli Beáta
• 12. Introduction to aseptic preparation: methods of sterilization, pyrogens and viral safety - Lemli Beáta
• 13. Preparation of dosage forms of parenteral administration: injections (basics, APIs, solvents, preparation and examinations) - Lemli Beáta
• 14. Preparation of dosage forms of parenteral administration: injections (basics, APIs, solvents, preparation and examinations) - Lemli Beáta
• 15. Preparation of dosage forms of parenteral administration: infusions and the technology of lyophilization - Lemli Beáta
• 16. Preparation of dosage forms of parenteral administration: infusions and the technology of lyophilization - Lemli Beáta
• 17. Preparation of dosage forms for oral administration: liquid and solid forms - Lemli Beáta
• 18. Preparation of dosage forms for oral administration: liquid and solid forms - Lemli Beáta
• 19. Interactions, incompatibilities and stability of drug products and biopharmaceuticals - Lemli Beáta
• 20. Interactions, incompatibilities and stability of drug products and biopharmaceuticals - Lemli Beáta
• 21. Basics of nanotechnology and advanced drug delivery systems - Lemli Beáta
• 22. Basics of nanotechnology and advanced drug delivery systems - Lemli Beáta
• 23. Drug design and development: CAD, DOE and Quality by Design (QbD) principles - Lemli Beáta
• 24. Drug design and development: CAD, DOE and Quality by Design (QbD) principles - Lemli Beáta
• 25. Integrated approach to dosage forms, drug delivery systems of different routes of administration and modified drug release - Lemli Beáta
• 26. Integrated approach to dosage forms, drug delivery systems of different routes of administration and modified drug release - Lemli Beáta
• 27. Original, generic and biosimilar products: comparison, bioequivalence and regulatory aspects - Lemli Beáta
• 28. Original, generic and biosimilar products: comparison, bioequivalence and regulatory aspects - Lemli Beáta

Gyakorlatok

• 1. Introduction to parenteral dosage forms – isotonic calculations I. - Lemli Beáta
• 2. Introduction to parenteral dosage forms – isotonic calculations II. - Lemli Beáta
• 3. Preparation of injections – practice I. - Lemli Beáta
• 4. Preparation of injections – practice II. - Lemli Beáta
• 5. Examination of injections I. - Lemli Beáta
• 6. Preparation of infusions – practice I. - Lemli Beáta
• 7. Preparation of infusions – practice II. - Lemli Beáta
• 8. Examination of infusions - Lemli Beáta
• 9. Preparation of albumin nanoparticles I. - Lemli Beáta
• 10. Preparation of albumin nanoparticles II. - Lemli Beáta
• 11. Examination of albumin nanoparticles - Lemli Beáta
• 12. Demonstration of interactions and incompatibilities in parenteral dosage forms - Lemli Beáta
• 13. Demonstration of industrial manufacture of medicines - Lemli Beáta
• 14. Practice test - Lemli Beáta

Szemináriumok

A tananyag elsajátításához szükséges segédanyagok

Kötelező irodalom

Saját oktatási anyag

Jegyzet

Ajánlott irodalom

James Swarbrick: Encyclopedia of Pharmaceutical Technology, Informa Healthcare, New York, London

Susanna Wu-Pong, Yon Rojanasakul: Biopharmaceutical Drug Design and Development, Humana Press

Gilbert S. Banker, Christopher T. Rhodes: Modern Pharmaceutics, Marcel Dekker Inc., New York- Basel

European Pharmacopoeia

Chris Langley, Dawn Belcher: Pharmaceutical Compounding and Dispensing, Pharmaceutical Press
Gary Gilleskie, Charles Rutter, Becky McCuen: Biopharmaceutical Manufacturing Principles, Processes, and Practices

Attila Dévay: The Theory and Practice of Pharmaceutical Technology, electronic book, PTE-Pécs

Attila Dévay: Investigation of Pharmaceutical Preparations, electronic book, PTE-Pécs

A félév elfogadásának feltételei

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Félévközi ellenőrzések

Students have to write three assessments during the semester and they have to reach 60 % after average calculation. After two assessments if students reach average 60 % taking into account both tests, writing the third assesment it not compulsory. The third assessments (which is considered as the 1st retake) has to above 60,1 %. If the student fails on the 3rd assessment, there is still chance for the 2nd retake, where student has to reach 60,1% for the acceptance of the semester. In case of confirmed absence from the assessment, re-take chance is sossible for the student. Missing the re-take results 0 % assessment.

Távolmaradás pótlásának lehetőségei

Students must fulfil requirements determined by the Code of Studies and Examinations.

All missed or failed preparations manufactured on the practice should be made up on supplementary practices!

Vizsgakérdések

The end-semester exam will be evaluated by a five-grade system. Knowledge acquired is tested based on subject matter defined by a list of topics provided by the institute.

At the end of semester, students have to take written exam.

Vizsgáztatók

• Kása Péter
• Lemli Beáta
• Pál Szilárd

Gyakorlatok, szemináriumok oktatói

• Kása Péter
• Lemli Beáta
• Pál Szilárd