PHA.03540.03 | 5 CP |
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Module label | Biopharmaceuticals |
Module code | PHA.03540.03 |
Semester of first implementation | |
Faculty/Institute | Institut für Pharmazie |
Module used in courses of study / semesters |
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Responsible person for this module | |
Further responsible persons |
Prof. Dr. B. Dräger |
Prerequisites | Module A: Optimization of bioprocesses; Module E: Introduction to pharmaceutical biotechnology |
Skills to be acquired in this module | Knowledge of the basic concepts of immune response Overview on immunotherapeutics, vaccines, antibodies, fusion proteins, future develop-ments Overview of the different types of monoclonal antibodies (mAbs) Knowledge of the targets for mAbs Knowledge of the PK and PD characteristics of mAbs Insight into mAbs under clinical development Insight into the currently approved mAbs Understanding of antibody production: polyclonal antibodies from mice, monoclonal an-tibodies from hybridoma cells, recombinant antibodies from bacteria Understanding of antibody action: specificity, affinity, avidity Understanding the background and basics of different immunological tests: ELISA, Western blot and hemagglutination test, practical experience. Understanding the production (phages, bacteria) and physical (Western blot) and func-tional (ELISA) characterization of different formats of recombinant antibodies: nanobod-ies, scFv. Practical experience in the purification of antibodies from sera by affinity chromatography Diseases relevant for DNA therapy Functional aspects of therapeutic DNA Delivery systems for DNA Current therapy strategies |
Module contents | Course K.1: Vaccines, Immunology Basic immunology: innate and specific immune response Basics of immune cell differentiation, B- and T-lymphocytes Basics of immune system receptors and signaling Basics of tumor immunology Basics of allergy sand autoimmune disease Vaccines in use and in development Antibodies for therapy and diagnosis Course K.2: Clinical development of monoclonal antibodies Basics of immunology Technical and methodical basics of production/selection of monoclonal antibodies by classical methods and advanced modern technologies The selection of monoclonal recombinant antibodies of different formats by Phage Dis-play, Screening Production of monoclonal antibodies in CHO cells including optimization of cell lines, cul-tivation, media, scale up as well as purification strategies and methods. Plant-based antibody production is generally explained with a specific focus to expres-sion enhancement, purification tags and glycol-engineering. Mechanisms of action of therapeutic antibodies Antibody optimization wrt pharmacokinetical half-life extension, ADCC and CDC Development of therapeutic anti-tumour antibodies Approval and necessary tests to perform phase I, II and II trials. Bleeding of immunized mice, production of sera, characterization by ELISA and Western blot Lab course: Observation of hybridoma cultures, harvest of supernantants, functional characterization by ELISA and Western blot Production of specific display phages, nanobodies and scFv in E. coli, physical characterization by Western blot and functional characterization by competitive ELISA Characterization of potentially neutralizing anti H5N1 antibodies in an hemagglutination test with plant-derived Virus-Like-Particles (VLPs) Course K.3: DNA for gene therapy DNA therapy: monogenic diseases, cancer Therapeutic DNA: structure, preparation, quality control, biological requirements Delivery systems: viral, liposomes, other - advantages/disadvantages Experimental test systems, cell culture, animal model Current therapy protocols |
Forms of instruction |
Lecture (2 SWS)
Lecture (1 SWS) Lecture (1 SWS) Course Practical training (2 SWS) |
Languages of instruction | German, English |
Duration (semesters) | 1 Semester Semester |
Module frequency | jedes Wintersemester |
Module capacity | unlimited |
Time of examination | |
Credit points | 5 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 |
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Course 1 | Lecture | Vaccines, Immunology | 2 | 0 | ||||
Course 2 | Lecture | Clinical development of monoclonal antibodies | 1 | 0 | ||||
Course 3 | Lecture | DNA for gene therapy | 1 | 0 | ||||
Course 4 | Course | Selbststudium | 0 | |||||
Course 5 | Practical training | Lab course on basics of immunological methods | 2 | 0 | ||||
Workload by module | 150 | 150 | ||||||
Total module workload | 150 |
Examination | Exam prerequisites | Type of examination | |
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Course 1 | |||
Course 2 | |||
Course 3 | |||
Course 4 | |||
Course 5 | |||
Final exam of module | attestation on lab course contents, Protocol on lab course |
Klausur |
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Exam repetition information |
Prerequisites and conditions | Prerequisites | Frequency | Compulsory attendance | Share on module grade in percent |
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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 | % |