MLU
PHA.06120.01 - K-PhBT: Biopharmaceuticals (Vollständige Modulbeschreibung)
Originalfassung Englisch
PHA.06120.01 5 CP
Modulbezeichnung K-PhBT: Biopharmaceuticals
Modulcode PHA.06120.01
Semester der erstmaligen Durchführung
Fachbereich/Institut Institut für Pharmazie
Verwendet in Studiengängen / Semestern
  • Pharmaceutical and Industrial Biotechnology (MA120 LP) (Master) > Pharmazie PharmacIndusBiotech.MA120, Akkreditierungsfassung gültig ab WS 2019/20 > Spezialisierung Pharmaceutical Biotechnology
  • Pharmaceutical and Industrial Biotechnology (MA120 LP) (Master) > Pharmazie PharmacIndusBiotech.MA120, Akkreditierungsfassung (WS 2015/16 - SoSe 2023) > Spezialisierung Pharmaceutical Biotechnology
Modulverantwortliche/r
Weitere verantwortliche Personen
H. Lilie
Teilnahmevoraussetzungen
Modules of the first semester (A-Both, B-PhBT, C-Both, D-Both)
Kompetenzziele
  • Knowledge of the concepts of the immune response
  • Basic knowledge about organs, cells and molecules of the immune system
  • Knowledge, how specific cellular and humoral immune responses are developed
  • Basic knowledge about autoimmune diseases
  • Basic knowledge about allergies
  • Knowledge about principles of tumor immunology including knowledge about selected examples of therapeutic anti-tumor antibodies
  • Knowledge about principles of vaccine development: selected examples from human and veterinary medicine
  • Basic knowledge about production/ selection and characterization of therapeutic mono-clonal antibodies and recombinant antibodies
  • 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 antibodies 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
  • Understanding the production (phages, bacteria) and physical (Western blot) and functional (ELISA) characterization of different formats of recombinant antibodies: nanobod-ies, scFv.
  • Diseases relevant for DNA therapy
  • Functional aspects of therapeutic DNA
  • Delivery systems for DNA
  • Current therapy strategies
Modulinhalte
Course K-PhBT.1 Vaccines, Immunology
  • Basic immunology about innate and specific immune response: Organs, cells and molecules of the immune system
  • Immune cell differentiation, B- and T-lymphocytes, development of the antibody and TCR repertoire
  • Interaction between cells and molecules in the immune system to develop specific humoral and cellular immune responses
  • Failures of the immune system: Basics of allergy and autoimmune disease
  • Basics of tumor immunology
  • Vaccines in application and in development
  • Antibodies for therapy and diagnosis
Course K-PhBT.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 Display, Screening
  • Production of monoclonal antibodies in CHO cells including optimization of cell lines, cultivation, media, scale up as well as purification strategies and methods.
  • Plant-based antibody production is generally explained with a specific focus to expression enhancement, purification tags and glycan-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
  • 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-PhBT.3: DNA for gene therapy
  • DNA therapy: monogenic diseases, cancer
  • Therapeutic DNA: structure, preparation, quality control, biological requirements
  • Delivery systems: viral, liposomes, others; advantages/disadvantages
  • Experimental test systems, cell culture, animal model
  • Current therapy protocols
Lehrveranstaltungsformen Seminar (2 SWS)
Seminar (3 SWS)
Seminar (1 SWS)
Kursus
Unterrichtsprachen Deutsch, Englisch
Dauer in Semestern 1 Semester Semester
Angebotsrhythmus Modul jedes Wintersemester
Aufnahmekapazität Modul unbegrenzt
Prüfungsebene
Credit-Points 5 CP
Modulabschlussnote LV 1: %; LV 2: %; LV 3: %; LV 4: %.
Faktor der Modulnote für die Endnote des Studiengangs 1
Modulveran­staltung Lehrveranstaltungs­form Veranstaltungs­titel SWS Workload Präsenz Workload Vor- / Nach­bereitung Workload selbstge­staltete Arbeit Workload Prüfung incl. Vorbereitung Workload Summe
LV 1 Seminar Project seminar 2 0
LV 2 Seminar Project seminar 3 0
LV 3 Seminar Project seminar 1 0
LV 4 Kursus Private study 0
Workload modulbezogen 150 150
Workload Modul insgesamt 150
Prüfung Prüfungsvorleistung Prüfungsform
LV 1
LV 2
LV 3
LV 4
Gesamtmodul
Attestation on project seminar contents, Protocol
Klausur
Wiederholungsprüfung
Regularien Teilnahme­voraussetzungen Angebots­rhythmus Anwesenheits­pflicht Gewicht an Modulnote in %
LV 1 Wintersemester Nein %
LV 2 Wintersemester Nein %
LV 3 Wintersemester Nein %
LV 4 Wintersemester Nein %