FABU1_15 Biopharmaceuticals

Faculty of Pharmacy
Autumn 2024
Extent and Intensity
1/0/0. 2 credit(s). Type of Completion: zk (examination).
In-person direct teaching
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
Timetable
each even Thursday 8:00–9:40 44-247
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 a relative molecular mass in most greater than 1 000 (in contrast to classical "chemical" medicines called "small molecules"). They are usually produced in other ways than by 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 (monomers' 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, hematopoietic factors, modified oligonucleotides, vaccines of all generations, and heparins. Biologic therapy grows rapidly during the past decades and is often considered to be the last chance in the treatment of cancer or autoimmune diseases. The wider usage of biotherapeutics is still slowed down by their high price. This problem is, however, being a step wisely overcome by the 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 group.
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)
    Modified receptor molecules as therapeutics.(Farsa)
    Drugs with peptide structure (except enzymes and antibodies). (Farsa)
    Antisense oligonucleotides. Poly- and oligosaccharides as drugs. (Farsa)
    Therapeutic monoclonal antibodies. (Farsa)
    Enzymes as drugs. (Farsa)
    Classical and modern vaccines. (Franc).
Literature
    recommended literature
  • 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.
  • Ministry of Health, Labour and Welfare of Japan. The Japanese Pharmacopoeia. 17th Edition, English version. Tokio, 2016.
  • Brian A. Baldo. Safety of Biologics Therapy: Monoclonal Antibodies, Cytokines, Fusion Proteins, Hormones, Enzymes, Coagulation Proteins, Vaccines, Botulinum Toxins. Springer International Publishing, 2016.ISBN 10: 0081002963
  • WHO. World Health Organization: International Nonproprietary Names (INN) for biological and biotechnological substances (a review), WHO/EMP/RHT/TSN/2016.1. Geneva, 2016.
  • WHO Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs). Geneva, 2013.
  • 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
English
Further Comments
Study Materials
The course can also be completed outside the examination period.
The course is also listed under the following terms Spring 2020, Autumn 2020, Autumn 2021, Autumn 2022, Autumn 2023.
  • Enrolment Statistics (recent)
  • Permalink: https://is.muni.cz/course/pharm/autumn2024/FABU1_15