PHA.03540.03 - Biopharmaceuticals (Vollständige Modulbeschreibung)

Prof. Dr. B. Dräger

Module A: Optimization of bioprocesses; Module E: Introduction to pharmaceutical biotechnology

• 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

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

attestation on lab course contents, Protocol on lab course

Klausur