MLU
PHA.06120.01 - K-PhBT: Biopharmaceuticals (Complete module description)
Original version English
PHA.06120.01 5 CP
Module label K-PhBT: Biopharmaceuticals
Module code PHA.06120.01
Semester of first implementation
Faculty/Institute Institut für Pharmazie
Module used in courses of study / semesters
  • Pharmaceutical and Industrial Biotechnology (MA120 LP) (Master) > Pharmazie PharmacIndusBiotech.MA120, Version of accreditation valid from WS 2019/20 > Spezialisierung Pharmaceutical Biotechnology
  • Pharmaceutical and Industrial Biotechnology (MA120 LP) (Master) > Pharmazie PharmacIndusBiotech.MA120, Version of accreditation (WS 2015/16 - SoSe 2023) > Spezialisierung Pharmaceutical Biotechnology
Responsible person for this module
Further responsible persons
H. Lilie
Prerequisites
Modules of the first semester (A-Both, B-PhBT, C-Both, D-Both)
Skills to be acquired in this module
  • 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
Module contents
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
Forms of instruction Seminar (2 SWS)
Seminar (3 SWS)
Seminar (1 SWS)
Course
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: %.
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 Seminar Project seminar 2 0
Course 2 Seminar Project seminar 3 0
Course 3 Seminar Project seminar 1 0
Course 4 Course Private study 0
Workload by module 150 150
Total module workload 150
Examination Exam prerequisites Type of examination
Course 1
Course 2
Course 3
Course 4
Final exam of module
Attestation on project seminar contents, Protocol
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 %