PHA.03539.02 - Technological and clinical aspects of biopharmaceuticals (Vollständige Modulbeschreibung)

Prof. Dr. M. Pietzsch

Module D: Introduction to Bioprocess technology; Module H: Validation of process and product

• Knowledge of formulation principles for biotech products • Challenges of protein formulations • Knowledge of formulation processes and ingredients • Knowledge of drug delivery mechanisms and kinetics • Knowledge of parenteral controlled release formulations • Knowledge on posttranslational modifications of proteins in vivo • Rationale behind posttranslational modification of proteins • Know-how to synthetically modify proteins in vitro • Knowledge on the application of biocatalysts for the synthesis of drugs • Biosynthetic pathways of plant secondary metabolites • Regulatory mechanisms of metabolite production • Plant-derived pharmaceuticals • Strategies to produce metabolites in transgenic plants • Successful examples of pharmaceutical production in plants • Knowledge of the basic concepts of Pharmacokinetics • Overview on the pharmacokinetic models • Knowledge concerning the relevant pharmacokinetic parameters • Basics of the physiological background of the Pharmacokinetics • Application of the pharmacokinetic evaluation on selected drugs

Course I.1: Drug delivery • Principles of protein formulation • Rational based formulation development / Formulation Screening • Stabilization principles for proteins • Controlled Release: Principles, Materials and Kinetics • In vitro - In vivo Correlation of Drug Release
Course I.2: Covalent modifications of proteins • Posttranslational modifications found in nature, e. g. glycosylation, farnesylation, phos-phorylation, protein-protein cross-linking, protein splicing, oxidation, etc. • Enzymes involved in posttranslational modification • Bio and chemo catalysis for the in vitro modification of proteins, e. g. PEGylation, transglutaminase, lysyl oxidase. • Application of biocatalysts in drug synthesis and enzyme technology, e. g. synthesis of semi-synthetic penicillin’s, synthesis of optically pure D-amino acids, regiospecific hy-droxylation of steroids, etc.
Course I.3: Advanced course on plant cell technology • Induction and subcultivation of plant cell cultures • Induction and cultivation of organ cultures • Selection of cell strains by cell aggregat and protoplast cloning • Introduction of foreign genetic material into plant cells • Expression of foreign genetic material using plant cell and hairy root cultures • In vitro storage of plant cell culture and meristems by cryopreservation
Course I.4: Pharmacokinetics • General Introduction and history of Pharmacokinetics • Pharmacokinetic concepts and models • Pharmacokinetic characterization of drug using relevant parameters • Physiological and physicochemical background • Application of the pharmacokinetic analysis on drugs and formulations • Relevant routes of administration

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