FABU1_15 Biopharmaceuticals

Faculty of Pharmacy
Spring 2020
Extent and Intensity
1/0/0. 2 credit(s). Type of Completion: zk (examination).
Teacher(s)
doc. PharmDr. Oldřich Farsa, Ph.D. (lecturer)
Guaranteed by
doc. PharmDr. Oldřich Farsa, Ph.D.
Department of Chemical Drugs – Departments – Faculty of Pharmacy
Course Enrolment Limitations
The course is also offered to the students of the fields other than those 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.
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)
    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)
    Immunopeparations. Vaccines of both traditional and novel type.(Farsa)
    Specific methods of analysis of biologics. (Farsa)
Literature
    required literature
  • 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
  • Ng Rick. Drugs: From Discovery to Approval. Second Edition. 2009. ISBN 978-0-470403587. URL info
    not specified
  • Ministry of Health, Labour and Welfare of Japan. The Japanese Pharmacopoeia ? 17th Edition, English version. Tokio, 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
Teaching methods (in Czech)
Přednášení
Assessment methods (in Czech)
Známkou
Písemná zkouška
Language of instruction
English
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 they were presented in lectures.
The course is also listed under the following terms Autumn 2020, Autumn 2021, Autumn 2022, Autumn 2023, Autumn 2024.
  • Enrolment Statistics (Spring 2020, recent)
  • Permalink: https://is.muni.cz/course/pharm/spring2020/FABU1_15