Pharmaceutical Biotechnology

Course goals

• Know how a protein is being made and transported in living cells, how it folds and how its structure determines its activity   
• Know how the stability of proteins can be influenced by engineering and/or formulation
• Know how DNA and RNA is being made and transported in living cells, how it can be synthesized and how transcription and translation works in prokaryotic and eukaryotic cells. 
• Know the differences between a prokaryotic and eukaryotic cell in terms of structural organization, speed of growth and protein synthesis.
• Be able to setup a cloning scheme for the recombinant production of therapeutic proteins (from sequence to protein) 
• Know the most important techniques for the structural and functional characterization of biomacromolecules such as proteins, RNA and DNA.
  Mass Spectrometry, Analytical separation methods (HPLC, SEC, FFF, electroforesis), PCR/Northern/Southern Blotting, ELISA/Western Blotting, Cell-based assays
• Know the various separation techniques for the purification of recombinant proteins (e.g. filtration, precipitation, centrifugation, column chromatography)
• Be able to rationally choose combinations of separation techniques (downstream processing) based on the physicochemical characteristics of a recombinant protein
• Be able to identify factors that can influence the pharmacokinetics and pharmacodynamics of biopharmaceuticals
• Understand how living cells can be used for therapy in humans:  - Regenerative medicine, - Bone marrow transplantation, - Immunotherapy
• Understand the role of regulatory bodies in the registration of biopharmaceutical products in Europe and the US
• Understand the ethical and economic implications of the production and use of biopharmaceuticals
• Understand the importance of proper registration of your lab experiments for reproducibility

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