aFABL1_15 Biological Medicinal Products

Faculty of Pharmacy
Autumn 2025

The course is not taught in Autumn 2025

Extent and Intensity
2/0/0. 3 credit(s). Type of Completion: zk (examination).
Teacher(s)
doc. PharmDr. Oldřich Farsa, Ph.D. (lecturer)
doc. PharmDr. Aleš Franc, Ph.D. (lecturer)
Guaranteed by
doc. PharmDr. Oldřich Farsa, Ph.D.
Department of Chemical Drugs – Departments – Faculty of Pharmacy
Prerequisites (in Czech)
aFABT1_16 Pharmaceutical Biotechnology && aFAFK3_14 Pharmacology III
Course Enrolment Limitations
The course is only offered to the students of the study fields the course is directly associated with.
fields of study / plans the course is directly associated with
Abstract
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.
Learning outcomes
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.
Key topics
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)
Study resources and literature
    recommended literature
  • FARSA, Oldřich and Peter ZUBÁČ. Protein and Small-Molecule Leucopoiesis and Thrombopoiesis Stimulators. Mini-reviews in medicinal chemistry. Sharjah: Betham Science Publ Ltd., 2021, vol. 21, No 13, p. 1638-1645. ISSN 1389-5575. Available from: 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
Approaches, practices, and methods used in teaching
Lectures.
Method of verifying learning outcomes and course completion requirements
A grade. A written exam: a test combining multiple-choice questions and questions requiring verbal answers or answers by drawing a structure.
Alternate completion
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.
Language of instruction
English
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