PHA.03539.02 | 10 CP |
---|---|
Module label | Technological and clinical aspects of biopharmaceuticals |
Module code | PHA.03539.02 |
Semester of first implementation | |
Faculty/Institute | Institut für Pharmazie |
Module used in courses of study / semesters |
|
Responsible person for this module | |
Further responsible persons |
Prof. Dr. M. Pietzsch |
Prerequisites | Module D: Introduction to Bioprocess technology; Module H: Validation of process and product |
Skills to be acquired in this module | 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 |
Module contents | 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 penicillins, 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 |
Forms of instruction |
Lecture (2 SWS)
Lecture (2 SWS) Lecture (2 SWS) Lecture (2 SWS) Course |
Languages of instruction | German, English |
Duration (semesters) | 1 Semester Semester |
Module frequency | jedes Wintersemester |
Module capacity | unlimited |
Time of examination | |
Credit points | 10 CP |
Share on module final degree | Course 1: %; Course 2: %; Course 3: %; Course 4: %; Course 5: %. |
Share of module grade on the course of study's final grade | 1 |
Module course label | Course type | Course title | SWS | Workload of compulsory attendance | Workload of preparation / homework etc | Workload of independent learning | Workload (examination and preparation) | Sum workload |
---|---|---|---|---|---|---|---|---|
Course 1 | Lecture | Drug delivery | 2 | 0 | ||||
Course 2 | Lecture | Covalent modification(s) of proteins | 2 | 0 | ||||
Course 3 | Lecture | Advanced course on plant cell technology | 2 | 0 | ||||
Course 4 | Lecture | Pharmacokinetics | 2 | 0 | ||||
Course 5 | Course | Selbststudium | 0 | |||||
Workload by module | 300 | 300 | ||||||
Total module workload | 300 |
Examination | Exam prerequisites | Type of examination | |
---|---|---|---|
Course 1 | |||
Course 2 | |||
Course 3 | |||
Course 4 | |||
Course 5 | |||
Final exam of module | 1 Protokoll |
Klausur |
|
Exam repetition information |
Prerequisites and conditions | Prerequisites | Frequency | Compulsory attendance | Share on module grade in percent |
---|---|---|---|---|
Course 1 | Winter semester | No | % | |
Course 2 | Winter semester | No | % | |
Course 3 | Winter semester | No | % | |
Course 4 | Winter semester | No | % | |
Course 5 | Winter semester | No | % |