FDBFa_FAF Biological Medicinal Products

Farmaceutická fakulta
jaro 2025
Rozsah
2/0/0. 5 kr. Ukončení: zk.
Vyučováno kontaktně
Vyučující
doc. PharmDr. Oldřich Farsa, Ph.D. (přednášející)
Garance
doc. PharmDr. Oldřich Farsa, Ph.D.
Farmaceutická fakulta
Dodavatelské pracoviště: Ústav chemických léčiv – Ústavy – Farmaceutická fakulta
Omezení zápisu do předmětu
Předmět je určen pouze studentům mateřských oborů.
Mateřské obory/plány
Cíle předmětu
Biologic therapeutics incerase rapidly in number in recent decades. Their growth has mainly accelerated since aprovals of biosimilars by the European Medicines Agency (EMA) had started. Not only notoriuosly known therapeutic monoclonal antibodies are in spotlight but also heamotopoietic stimulators, protein and peptide hormones, cytokines and therapeutic enzymes and also polymeric molecules of other than peptide character such as antisense oligonucleotides and olig- or polysaccharides must be taken into account. Vaccines also cannot be passed over although the look of their contemporary versions such as mRNA vaccines is today completely different from initial dead or attenuated patogens. The goal of the advanced course intended for Ph.D. students is not only to present pharmacotherapeutic aspects of these medicines but also to acquaint students with their structure aspects on various levels including semi-synthetic modifications and also with methods of ther analysis and quality assessment.
Výstupy z učení
A DSP student, which passes the subject, should have relatively detailed knowledge about structures, analytics, mechanisms of action, and pharmacology of those structure groups of biopharmaceuticals, which will be preliminarily agreed among the student, his tutor, and examiner.
Osnova
Biologic therapeutics and classical medicines, definitions and terminology. History, up-to-date state, classification of biologic therapeutics, fundamentals of nomenclature, main features of individual groups.
Originator products and biosimilars.
Modified receptor molecules as medicines.
Imunology preaparatios. Classic and modern vaccines.
Therapeutic peptides and proteins (except enzymes, antibodies and haematopoietic factors).
Haematopoietic growth factors.
Antisense oligonucleotides.
Poly- and oligosaccharides as medicines.
Therapeutic enzymes.
Research and development of biologic therapeutics.
Analysis and quality control of biologic therapeutics.
Literatura
    doporučená literatura
  • Immune aspects of biopharmaceuticals and nanomedicines. Edited by Raj Bawa - János Szebeni - Thomas J. Webster - Gerald F. Audette. Singapore: Pan Stanford Publishing, 2018, xliv, 994. ISBN 9789814774529. info
  • Biosimilars of monoclonal antibodies : a practical guide to manufacturing, preclinical, and clinical development. Edited by Cheng Liu - John Morrow. Hoboken, New Jersey: Wiley, 2017, 1 online. ISBN 9781118940631. URL info
  • Vaccines. Edited by Stanley A. Plotkin - Walter A. Orenstein - Paul A. Offit. Sixth edition. [Spojené státy americké]: Elsevier Saunders, 2013, 1 online. ISBN 9781455737987. URL info
Výukové metody
Methods of work with a text by a student himself/herself (a textbook, a book, a journal article via internet)
Metody hodnocení
Oral exam or written test.
Vyučovací jazyk
Angličtina
Předmět je zařazen také v obdobích podzim 2025, jaro 2026.