Syllabus
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.
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.
Annotation
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.