F1BU1_15 Biopharmaceuticals

Faculty of Pharmacy
Autumn 2021
Extent and Intensity
1/0/0. 2 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
Supplier department: Department of Chemical Drugs – Departments – Faculty of Pharmacy
Timetable
each odd Friday 12:40–14:20 44-056
Prerequisites (in Czech)
FAKULTA(FaF) || OBOR(MUSFaF)
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
Course objectives
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 usually produced by other way than by a common chemical synthesis (recombinant technologies are typical). 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; at least 5 examples of drugs in use or development from every structural groups.
Syllabus
  • 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 terminology. (Farsa)
    Immunopeparations. Vaccines of both traditional and novel type. (assoc. prof.Aleš Franc from Department of Pharmaceutical Technology)
    Drugs with peptide structure (except enzymes and antibodies). (Farsa)
    Antisense oligonucleotides. Poly- and oligosacharides as drugs. (Farsa)
    Therapeutic monoclonal antibodies. (Farsa)
    Enzymes as drugs. (Farsa)
    Specific methods of analysis of biologics. (Farsa)
Literature
    recommended literature
  • Beneš L. Biofarmaceutika (Bioléčiva) Chem. listy 101, 18 - 24 (2007). URL info
  • Chrastilová Z., Macková M., Král V. Bioléčiva - jaký je jejich skutečný potenciál? Chem. listy 101, 25 - 35 (2007). 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
  • Farsa O. Terapeutické monoklonální protilátky v léčbě a ve vývoji. Praha, 2013. URL info
  • Ng Rick. Drugs: From Discovery to Approval. Second Edition. 2009. ISBN 978-0-470403587. URL info
Teaching methods
Lectures.
Assessment methods
A grade. A written quiz.
Language of instruction
Czech
Further comments (probably available only in Czech)
Study Materials
The course can also be completed outside the examination period.
Teacher's information
Knowledge of biologic drugs in the range as it was presented in lectures.
The course is also listed under the following terms Spring 2020, Autumn 2020, Autumn 2022, Autumn 2023, Autumn 2024.
  • Enrolment Statistics (Autumn 2021, recent)
  • Permalink: https://is.muni.cz/course/pharm/autumn2021/F1BU1_15