SubjectsSubjects(version: 941)
Course, academic year 2022/2023
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Biological Drugs - GF305
Title: Biologická léčiva
Guaranteed by: Department of Pharmaceutical Chemistry and Pharmaceutical Analysis (16-16190)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2022
Semester: winter
Points: 0
E-Credits: 1
Examination process: winter s.:written
Hours per week, examination: winter s.:14/0, Ex [HS]
Capacity: unlimited / unknown (unknown)
Min. number of students: unlimited
Virtual mobility / capacity: no
Key competences:  
State of the course: taught
Language: Czech
Teaching methods: full-time
Teaching methods: full-time
Note: deregister from the exam date if a requisite was not fulfilled
course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: doc. PharmDr. Miroslav Miletín, Ph.D.
Co-requisite : GF339
Pre-requisite : GF143, GF370
Annotation -
Last update: doc. PharmDr. Miroslav Miletín, Ph.D. (19.09.2023)
Biologicals belong among the most quickly developing groups of therapeutics. The subject Biological drugs affords information about main types of biologics, essentials of their structure, modifications and resulting pharmacokinetic as well pharmaceutical properties. It gives overview of biologics in most important indications, basic information about legislation, regulations of biologics, specifics of registration of either original preparations or biosimilars. The subject also summarizes methods of qualitative and quantitative assays of biologics.
Course completion requirements -
Last update: doc. PharmDr. Miroslav Miletín, Ph.D. (19.09.2023)


Literature -
Last update: doc. PharmDr. Miroslav Miletín, Ph.D. (19.09.2023)


  • Karel Pavelka, Petr Arenberger, Milan Lukáš, Tomáš Zima, Tomáš Doležal, Marta Olejárová, Petra Cetkovská a kolektiv. Biologická léčba zánětlivých autoimunitních onemocnění. Praha: Grada, 2014, s. ISBN 978-80-247-5048-4.
  • Fusek Martin,Vítek Libor,Blahoš Jaroslav,Hajdúch Marián,Ruml Tomáš, a kolektiv. Biologická léčiva: Teoretické základy a klinická praxe. Praha: Grada Publishing , 2012, s. ISBN 978-80-247-3727-0.

Syllabus -
Last update: doc. PharmDr. Miroslav Miletín, Ph.D. (19.09.2023)

Therapeutic peptides

  • History of peptides use in therapy
  • Structural characteristics and properties of therapeutically used peptides
  • Chemical and biochemical modifications of peptides for improvement of pharmacokinetic properties
  • Overview of most important groups of therapeutic peptides except of monoclonal antibodies and fusion peptides

 Stem cells, cell therapy

  • Types of stem cells
  • Methods of stem cells obtaining
  • Applications of stem cells
  • CAR-T cell therapy 

 Structural types, properties and modifications of monoclonal antibodies

  • Modifications of structure influencing pharmacologic and pharmacokinetic properties of monoclonal antibodies and other peptide and protein biologics.
  • Constitutional types of monoclonal antibodies generally and considering of mechanism of action (monoclonal antibodies naked and conjugated).

 Monoclonal antibodies and low-molecular inhibitors of cell signalization in therapy of cancer diseases

  • Targeted therapy of cancer diseases and therapeutic influence on cell signalization systems and processes – up-to-date molecular approaches based on biologics and low molecular cell signalization inhibitors.
  • Overview of actual therapeutic use of monoclonal antibodies focused on anti-cancer therapy.

 Monoclonal antibodies in therapy of other then cancer diseases

  • Overview of actual therapeutic use of monoclonal antibodies and other biologics aside of cancer diseases, primarily at rheumatoid arthritis and multiple sclerosis.

 Development, registrations and distribution of biologics

  • Differences between and principles used in development, manufacture and registration of biologics and „small molecules“

Nucleic acids structure based biological drugs

  • Structural predispositions and mechanisms of action
  • Modifications of structure improving activity, stability in biological environment and pharmacokinetic properties of oligonucleotide therapeutics.
  • Oligonucleotide Mediated Gene Therapy (antisense therapeutics).
  • Vector Mediated Gene Therapy.
  • Gentic vaccines.
  • Oligonucleotide aptamers.

Methods of qualitative and quantitative analysis of biological drugs

  • Approaches to analytical evaluation of biological drugs.
  • Methods most frequently used for characterization of biological drugs.
  • Identification, evaluation of quality and assays of biological drugs.
Learning resources -
Last update: doc. PharmDr. Miroslav Miletín, Ph.D. (19.09.2023)

Study materials on the FaF UK web site.

Teaching methods -
Last update: doc. PharmDr. Miroslav Miletín, Ph.D. (19.09.2023)


Requirements to the exam -
Last update: doc. PharmDr. Miroslav Miletín, Ph.D. (19.09.2023)

Successfully write the exam test.

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