SubjectsSubjects(version: 944)
Course, academic year 2023/2024
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Biological Drugs - GAF305
Title: Biological Drugs
Guaranteed by: Department of Pharmaceutical Chemistry and Pharmaceutical Analysis (16-16190)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2023
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
4EU+: no
Virtual mobility / capacity: no
Key competences:  
State of the course: taught
Language: English
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.
Comes under: 3.ročník 2023/24 AJ
Co-requisite : GAF339
Pre-requisite : GAF143, GAF370
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)


  • Wei Wang (Editor), Manmohan Singh (Editor). Biological Drug Products. Developments and Strategies. Hoboken, New Jersey: Wiley, 2014, s. ISBN 978-1-118-14889-1.

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 (mAbs)

  • 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).

mAbs - mechanisms of action

  • Overview of mechanisms of action of most frequently used monoclonal antibodies.

Monoclonal antibodies in therapy of autoimmune diseases

  • Overview of actual therapeutic use of monoclonal antibodies and other biologics in therapy ou autoimune 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.
  • Genetic 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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