aFABL1_15 Biological Medicinal Products

Farmaceutická fakulta
podzim 2025

Předmět se v období podzim 2025 nevypisuje.

Rozsah
2/0/0. 28p. 3 kr. Ukončení: zk.
Vyučující
doc. PharmDr. Oldřich Farsa, Ph.D. (přednášející)
doc. PharmDr. Aleš Franc, Ph.D. (přednášející)
Garance
doc. PharmDr. Oldřich Farsa, Ph.D.
Ústav chemických léčiv – Ústavy – Farmaceutická fakulta
Omezení zápisu do předmětu
Předmět je určen pouze studentům mateřských oborů.
Mateřské obory/plány
Cíle předmětu
Biological Medicinal Products or simply Biotherapeutics ("or biological and biotechnological substances" in WHO terms) are medicines with relative molecular mass in most greater than 1 000 (in contrast to classical "chemical" medicines called "small molecules"). They are typically produced by other way than by a common chemical synthesis (recombinant technologies are the most typical ones in production of proteine structure drugs). They mostly have neither exactly defined chemical structure nor exactly known relative molecular mass because they are often mixtures of structurally related biopolymers. They frequently exhibit primary structure (monomeres' sequence, eg. that of amino acids, nucleotides or monosaccharides) and secondary, tertiary and quarternary one. This group includes eg. monoclonal antibodies, modified receptor molecules, protein and peptide hormones, cytokines, haematopoietic factors, modified oligonucleotides, vaccines of all generations and heparines. Biologic therapy grows rapidly during past decades and is often considered to be the last chance in treatment of cancer or autoimune diseases. The wider usage of biotherapeutics is still slowed down by their high price. This problem is, however, beeing stepwisely overcome by introduction of biosimilar products which mean an analogy of generics in terms of small molecules.
Výstupy z učení
A student will, after passing the subject, be capable to enumerate:
- main groups of biologic drugs;
- their main structural characteristics;
- their general mechanisms of activity;
- the names, approximate structure, mechanism of action and use of biotherapeutics presented at the lectures.
Osnova
Content of the discipline expressed as topics of lectures:
Biological therapeutics (biologics) and conventional small molecule drugs - definition, history, contemporary situation, classification of biologics, fundamentals of their INN nomenclature. (Farsa)
Immunopeparations. Vaccines of both traditional and novel type. (assoc. prof.Aleš Franc from Department of Pharmaceutical Technology)
Drugs with peptide structure (except for enzymes and antibodies). (Farsa)
Therapeutic oligonucleotides. Poly- and oligosacharides used as medicines. (Farsa)
Therapeutic monoclonal antibodies. (Farsa)
Modified receptor molecules and transmembrane proteins as medicines.(Farsa)
Enzymes as drugs. (Farsa)
Literatura
    doporučená literatura
  • FARSA, Oldřich a Peter ZUBÁČ. Protein and Small-Molecule Leucopoiesis and Thrombopoiesis Stimulators. Mini-reviews in medicinal chemistry. Sharjah: Betham Science Publ Ltd., 2021, roč. 21, č. 13, s. 1638-1645. ISSN 1389-5575. Dostupné z: https://doi.org/10.2174/1389557521999201230195926. URL info
  • Ministry of Health, Labour and Welfare of Japan. The Japanese Pharmacopoeia ? 17th Edition, English version. Tokio, 2016. URL info
  • WHO. World Health Organization: International Nonproprietary Names (INN) for biological and biotechnological substances (a review), WHO/EMP/RHT/TSN/2016.1. Geneva, 2016. URL info
  • U.S. Department of Health and Human Services Food and Drug Admin. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Silver Spring, MD, USA, 2015. URL info
  • WHO Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs). Geneva, 2013. URL info
  • Ng Rick. Drugs: From Discovery to Approval. Second Edition. 2009. ISBN 978-0-470403587. URL info
Výukové metody
Lectures.
Metody hodnocení
A grade. A written exam: a test combining multiple-choice questions and questions requiring verbal answers or answers by drawing a structure.
Náhradní absolvování
In the case of a study trip abroad, participation in lectures can be replaced by self-study presentations from the interactive curriculum. The date of the exam will then be determined by agreement with the course guarrantor.
Vyučovací jazyk
Angličtina
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