Description of courses offered in MLU- Halle
Modul: Biopharmaceuticals
Learning objectives:
•Knowledge of the basic concepts of immune response • Overview on immunotherapeutics, vaccines, antibodies, fusion proteins, future developments • 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, 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
Content:
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 and 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, 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 glycol-engineering. • Mechanisms of action of therapeutic antibodies • Antibody optimization with 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
5 ECTS
Modul: Technological and clinical aspects of biopharmaceuticals
Learning objectives:
• 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
Content:
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, phosphorylation, 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 penicillin’s, 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 aggregation 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
10 ECTS
Modul: Biopharmaceuticals in regenerative medicine
Learning objectives:
• Knowledge on the application of Biopharmaceuticals in `Regenerative Medicine`, Clarification of terms and definitions • Overview about biopharmaceuticals interesting for Regenerative Medicine • General techniques to embed or attach biopharmaceuticals to carriers or their single application • Preparation of carriers and scaffolds • Effects of biopharmaceuticals on mammalian cells and whole organism • Adverse reactions of organism on carriers and biopharmaceuticals • Selection and manipulation of cells • Selected examples of biopharmaceutical application in regenerative medicine
Content:
1. Basic concepts of biopharmaceuticals application in regenerative medicine
Introduction to regenerative medicine • Biopharmaceuticals in regenerative medicine • Target validation and delivery of biopharmaceuticals • Cell adhesion, migration, and growth • Regulation of signal transduction, gene expression, differentiation • Blood compatibility of carriers and biopharmaceuticals • Immunocompatibility of carriers and biopharmaceuticals • Histocompatibility of carriers and biopharmaceuticals
2. Application of biopharmaceuticals in regenerative medicine
• Preparation of carriers and scaffolds • Techniques to functionalize carriers and scaffolds • Concept of biomimetics • Techniques for immobilization and delivery of biopharmaceuticals • Cells in regenerative medicine • Adult and embryonic stem cells • Examples of biopharmaceutical application for regeneration of different tissues
3. Lab course on application of biopharmaceuticals for regeneration of bone • Preparation of model scaffold • Embedding of adhesive proteins and growth factors • Studies of mesenchymal stem cell adhesion and differentiation
Modul: Project work
Learning objectives:
First independent research experience for the students • literature studies and experimental work • writing of reports • defending results
Content:
Participation in a research work of departments involved in BEAM project • introduction to independent research work with combination of literature studies and experimental research on a specific topic • writing a research report and oral presentation of the results
Modul: Biopharmaceuticals
Learning objectives:
•Knowledge of the basic concepts of immune response • Overview on immunotherapeutics, vaccines, antibodies, fusion proteins, future developments • 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, 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
Content:
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 and 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, 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 glycol-engineering. • Mechanisms of action of therapeutic antibodies • Antibody optimization with 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
5 ECTS
Modul: Technological and clinical aspects of biopharmaceuticals
Learning objectives:
• 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
Content:
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, phosphorylation, 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 penicillin’s, 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 aggregation 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
10 ECTS
Modul: Biopharmaceuticals in regenerative medicine
Learning objectives:
• Knowledge on the application of Biopharmaceuticals in `Regenerative Medicine`, Clarification of terms and definitions • Overview about biopharmaceuticals interesting for Regenerative Medicine • General techniques to embed or attach biopharmaceuticals to carriers or their single application • Preparation of carriers and scaffolds • Effects of biopharmaceuticals on mammalian cells and whole organism • Adverse reactions of organism on carriers and biopharmaceuticals • Selection and manipulation of cells • Selected examples of biopharmaceutical application in regenerative medicine
Content:
1. Basic concepts of biopharmaceuticals application in regenerative medicine
Introduction to regenerative medicine • Biopharmaceuticals in regenerative medicine • Target validation and delivery of biopharmaceuticals • Cell adhesion, migration, and growth • Regulation of signal transduction, gene expression, differentiation • Blood compatibility of carriers and biopharmaceuticals • Immunocompatibility of carriers and biopharmaceuticals • Histocompatibility of carriers and biopharmaceuticals
2. Application of biopharmaceuticals in regenerative medicine
• Preparation of carriers and scaffolds • Techniques to functionalize carriers and scaffolds • Concept of biomimetics • Techniques for immobilization and delivery of biopharmaceuticals • Cells in regenerative medicine • Adult and embryonic stem cells • Examples of biopharmaceutical application for regeneration of different tissues
3. Lab course on application of biopharmaceuticals for regeneration of bone • Preparation of model scaffold • Embedding of adhesive proteins and growth factors • Studies of mesenchymal stem cell adhesion and differentiation
Modul: Project work
Learning objectives:
First independent research experience for the students • literature studies and experimental work • writing of reports • defending results
Content:
Participation in a research work of departments involved in BEAM project • introduction to independent research work with combination of literature studies and experimental research on a specific topic • writing a research report and oral presentation of the results
