1. Biotechnological drugs (biopharmaceuticals).
L: Biomanufacturing revolutions during history and representative products. Reference, generic, biosimilars and biobetters. Therapeutic proteins obtained by cell-free system technology. Glyco-engineering application in biopharmaceuticals improvement.
S: Challenges for biotechnological engineers in the 21 century regarding biopharmaceuticals.
2. Bioprocessing of biopharmaceutical production.
L: Upstream and downstream bioprocesses. Single-use technology application. Continuous bioprocessing. Modern, advanced and alternative separation techniques in biopharmaceutical production. Bioprocess integration. Final product formulation – Improvement of biopharmaceuticals’ stability and activity by current drug delivery technologies. Circular (recycling) economy in biopharmaceutical factory.
S: Next-generation biopharmaceutical production.
E: Industrial laboratory visit and exercises: Croatian Veterinary Institute Zagreb: application of Atomic absorption spectroscopy (AAS), Inductively coupled plasma atomic emission spectroscopy (ICP-OES) and Liquid chromatography–tandem mass spectrometry, Gas Chromatography - Tandem Mass Spectrometry (LC-MS-MS, GC-MS-MS) in conducting validated methods for biopharmaceuticals’ determination
3. Microbial biopharmaceuticals produced with natural and recombinant bacteria.
L: Production of biopharmaceuticals by E. coli - endotoxin detection and removal. Inclusion bodies separation - solubilization and renaturation of therapeutic proteins. „Live biotherapeutic products“ according to US FDA. Diabetes biopharmaceuticals, plasma proteins, recombinant proteins and microbial enzymes as biotherapeutics.
S: Production of biopharmaceuticals by bacteria.
E: Qualitative and quantitative determination of biopharmaceuticals by microbiological methods on solid and liquid culture media: detection of the microbial production in situ and determination of the unknown concentration of a pure substance by diffusion method.
4. Microbial biopharmaceuticals produced with natural and recombinant yeasts and moulds.
L: Biotechnological production of ergot alkaloids and fine biochemicals - exopolysaccharides, lipids, carotenoides.
S: Biopharmaceuticals production by yeasts and moulds.
E: Application of quantitative enzyme-linked immunosorbent assay (ELISA) for determination of biopharmaceutical residues
5. Antimicrobial biotherapeutics other than antibiotics.
L: Antiviral microbial drugs, enzybiotics, glycoconjugates, engineered lantibiotics, unnatural and beta-aminoacids therapeutic peptides, quorum-sensing inhibitors).
S: Biotechnological production of antimicrobial biotherapeutics other than antibiotics.
E: Detection of the genes involved in the biosynthesis of potential biotechnological drugs by PCR method
6. Biopharmaceuticals and fine chemicals of plant origin
L: Plants as a source of biopharmaceuticals and fine chemicals. Introduction in plant cell culture and obtaining of GM plants. Production of secondary metabolites, therapeutic proteins, and edible vaccines by plant.
S: Application of plant cell culture in biocatalytic processes in preparation of pharmaceuticals and fine chemicals
E: Introduction to plant cell culture: preparation of cell culture medium, callus induction and subculture of callus
7. Biopharmaceuticals of marine origin
P: Marine organisms as a source of biopharmaceuticals and fine chemicals. Introduction of algae cultivation and obtaining of GM algae. Production of biopharmaceuticals, therapeutic proteins, vaccines, and specific enzymes by algae. Production of algae for oral administration of biopharmaceuticals.
E: Isolation and identification of biologically active compounds from macroscopic algae
8. Animal cell cultures in biopharmaceuticals production
L: Animal cell cultures in biotechnology. Products of animal cell technology.
S: Recombinant proteins and vaccines produced by animal cell cultures.
E: Introduction to animal cell culture-cultivation, trypsinization and growth curve.
9. Stem cells and tissue engineering
L: Isolation of stem cells and therapeutic application. Bioengineering of tissue and tissue grafts.
S: Tissue engineering for therapeutic purposes.
10. Regulatory issues for biopharmaceuticals
L: Regulatory issues for research, production, clinical trials, application and marketing of biopharmaceuticals. Regulatory authorities (national, regional, international) HALMED, FDA, EMA, WHO. Patenting in biotechnology.
S: Patent documents of biopharmaceuticals.
To enrol in this course, the following courses must be completed: