• Presentation of biologically and biotechnologically manufactured products with a focus on their application as innovative drugs (monoclonal antibodies, vaccines, gene therapy, cellular therapies).
• Fundamentals of drug development, also from a regulatory and economic perspective.
• Clinical development and associated challenges and aspects of tolerability and efficacy.
• Holistic view from the perspective of manufacturers and developers, but also patients.
• Fundamentals of genetics and immunology with regard to their application in the context of modern, biological therapeutic approaches and vaccines.

Blended learning

Final exam: Final written examination

• Introduction to eukaryotic cell culture
• Best practices to protect cell banks from mycoplasma contamination
• Molecular techniques to detect and prevent mycoplasma contamination
• Characterization of genetic variations

learning practical skills

Continuous assessment: Protocol submission

• Brief repetition: products, expression systems, customers
• Metabolic engineering: goals, preconditions, methods
• Product or production optimization
• Focus on biomedicine: antibodies - vaccines - gene therapy vectors
• Examples from recent literature
• Problems in production/upscaling

Blended learning

Final exam: Final inspection

Measurement and control technology:

• Basics of measurement technology; instrumentation of a bioreactor
• Controller types (PID controller, two-point controller, cascade control, etc.)
• Requirements for control loops (control quality, stability)
• Design of control loops, determination of controller parameters
• Control of bioreactor parameters (temperature, pH, pO2, power, pCO2, feed rate, etc.)

Automation:

• Fundamentals of plant automation (control technology, process control systems) and process control technology (step chains, sequence control)
• Introduction to Industry 4.0 and the concept of digital twins
• Practical design of a flow and level control system - Exercise in automation

Blended learning

Final exam: Final written examination

Introduction to thermodynamics

• Changes of state
• First law of thermodynamics
• Heat calculation
• Second law of thermodynamics
• Work - fluid systems
• Exergy
• Heat transfer
• Technical heat transfer

Blended learning

Final exam: Final written examination

Industrial hygiene:

• Good manufacturing practice
• Procedures to avoid harmful contamination
• Specific implementation and tools
• Operational elements

Sterilization and disinfection:

• Terms and concepts of sterilization, pasteurization, disinfection and cleaning
• Principles and correlation of different methods of germ inactivation
• Steam sterilization, chemical and thermal disinfection processes
• Calculation models for sterilization

Biosafety and biosecurity:

• Concepts of biosafety and worker protection in accordance with EN 45001
• Recognition, assessment and treatment of biological hazards in the context of the Austrian Ordinance on Biological Agents
• Biosafety: risk factors, risk classes, practical examples, technical safety measures, legal principles
• Biosecurity: Access security in the microbiological laboratory

Plant cleaning:

• Cleaning of surfaces in contact with the product
• Process and beverage matrices
• Analysis and planning of cleaning validation
• Exercise example for cleaning and cleaning validation, e.g. on a fermentor

Blended learning

Final exam: Intermediate examination (weighting 40%)

Final written examination (weighting 60%)

• The process schemes: Batch, fed-batch, semi-continuous and continuous for basic operations, especially fermentation.
• Process parameters for the design and evaluation of bioprocesses can be determined and evaluated (e.g. oxygen saturation, biomass concentration, product, substrate consumption, yield coefficients, etc.).
• Models for process transfer and scale-up
• Creation of digital twins of basic operations in bioprocess engineering

Blended learning

Final exam: Final written examination

• Differential and integral calculus
• Introduction to nth-order differential equations
• Separation of variables

Blended learning

Continuous assessment: immanent examination character

The course deals with statistical topics in the context of biostatistics:

Exploratory data analysis
Fundamentals of statistical inference (hypothesis testing)
Statistical modeling, model selection

• Non-linear functions; applying scale transformations to linearize non-linear dependencies;
• Distributions: In-depth: Normal, Poisson, binomial; log and gamma distribution; checking the normal distribution assumption (QQ plot, Shapiro-Wilk test); identifying outliers (Grubbs test);
• Parameters: Mean, median, variance; measures of location, dispersion and shape;
• Multivariate analysis; factors and cluster analysis; logistic analysis;
• Statistical tolerancing: calculation of measurement chains and basics of statistical tolerancing;
• Discussion of the error concept: dispersion, minimization, implementation in device tolerance, limit value and alarm value, sampling statistics and legal sampling plans, e.g. testing for sterility according to the pharmacopoeia
• Sampling: Calculating samples: being able to describe 1- and 2-dimensional samples with dimensional figures and graphs; planning minimum sample sizes to determine relevant deviations for simple alternative tests

Blended learning

Final exam: Homework, in class Participation, final examination

• Logic and aim of statistical comparative studies
• elementary evaluative statistics
• basic experimental designs
• errors in the statistical assessment of data
• required sample size
• Interpretation of P-value
• coefficient of determination and residual error
• elementary variance analysis methods, ANOVA, regression, etc.

Blended learning

Final exam: Partial performance and final written examination

Scale up internship at the Scientific Brewhouse

• Recipe scaling 20L to 150L (test brewing plant)
• Scale up of technical parameters
• Operation of an automated pilot plant
• Comparative study: 20L brew vs 150L brew
• Recording of analytical and technical parameters
• Quality control
• Filling into KEGs and bottles
• Labeling of the product

Learning practical skills

Continuous assessment: Protocol submission

In the course of this exercise, the exemplary production of a biopharmaceutical product is worked through and dealt with in all its aspects from process design and fermentation to harvesting and filtration.

The production systems are animal cells and microorganisms.

learning practical skills

Continuous assessment: Protocol submission

Plant engineering:

• Procedure for the planning and realization of systems
• Explanation of planning content and planning steps
• Arrangement of plant components with regard to the ideal design of material and personnel flows, taking hygiene requirements into account
• Spatial and qualitative design of the plant areas
• Outline of the necessary ancillary functions (supply and disposal)

Plant design:

• Basic specifications for apparatus, components and connections with regard to their construction and design as well as their material properties for use in bioprocess engineering

Technical risk management:

• Organization of projects
• Project concept
• Types of projects
• Methods of project planning and project control
• Project management approaches
• Project organization,
• Methods of project definition and project context analysis
• Roles in the project
• Requirements for project members
• Project culture
• Management skills

Blended learning

Final exam: Final written examination

In-depth study of thermodynamic processes:

• Circular processes
• Two-phase systems - Steam
• refrigeration technology

Technical energy systems:

• Introduction to energy systems
• Heat pump
• Renewable energy

Blended learning

Final exam: Final written examination

Process management and optimization

• Process analysis and design: Methods for analyzing and designing processes.
• Continuous improvement: principles and methods such as Kaizen and the PDCA cycle.
• Lean management: basics and application in process optimization.

Quality tools and techniques

• Seven quality tools: flow chart, cause-effect diagram, histogram, Pareto diagram, control chart, scatter diagram and check sheet.
• Failure mode and effects analysis (FMEA): implementation and benefits.

Quality testing and assurance

• Testing methods and techniques: Non-destructive testing, random testing.

Quality management in practice

• Case studies: Analysis and discussion of real case studies.
• Practical examples: Processing of case studies.

Management and communication

• Communication: Effective communication of quality management issues.
• Training and awareness: Development and implementation of training programs.

Lecture with structured exercises

Continuous assessment: Immanent performance assessment during the course (homework)

Basics of risk management:

• Terms relating to risk analysis;
• Typical areas of application and special legal aspects
• Cases of damage from the process industry;
• Risk assessment (qualitative, semi-quantitative, quantitative)

Methods:

• FMEA
• HAZOP
• Fault tree analysis (basics)

Application of special risk analysis methods:

• Fault tree analysis
• Event tree analysis and layer of protection analysis
• HACCP
• SWIFT (Structured What-If) Analysis, checklists

Blended learning

Final exam: Final written examination

• Basics of validation
• Regulatory requirements and guidelines
• Device and system qualification (DQ, IQ, OQ, PQ)
• Risk analysis
• Method validation
• Process validation
• Cleaning and sterilization validation
• Validation management and documentation

Blended learning

Continuous assessment: Blended learning tasks

Written final exam

• Introduction: Definitions of terms, reasons for use, overview of the market situation
• Biotechnological processes for the production of bio-based polymer materials or bio-based monomers as starting materials: fermentation raw materials and their availability, biotechnological production of selected products (PHAs, lactic acid and PLA)
• Chemical derivatization/synthesis of bioplastics; processing and shaping (in particular thermoplastic shaping processes such as extrusion and injection moulding); examples of practical processing methods

Blended learning

Continuous assessment: Speeches, presentations

Students learn the in-depth use of R for the analysis and visualization of data generated in bioprocess engineering.

• Programming with R
• Process and methods of data analysis
• Special packages for data analysis
• Visualization methods and packages
• Analysis methods that use artificial intelligence

Blended learning

Final exam: Project submission

• Structure of multi-factorial statistical experimental designs
• Differences between the various experimental designs in terms of scope, significance and results of the individual schemes
• Analysis of experiments based on t-statistics or the application of the General Linear Model (GLM).

Blended learning

Final exam: Partial performance and final written examination

• Sequence of downstream processes for protein purification
• Detailed consideration of important process steps such as centrifugation, filtration, precipitation, chromatography
• Scaling and design of downstream process steps

Blended learning

Continuous assessment: Final written exam

The aim is to purify and formulate a protein

• Practical implementation of several basic operations in downstream processing (DSP) on automated systems.
• Basic operations: Centrifugation, filtration, ultrafiltration, chromatographic methods,...
• Analytical "in-process control" and mapping of a sub-process as a hybrid model
• Formulation of the protein and freeze-drying
• Presentation and protocol of the process and evaluation of the purification

Learning practical skills

Continuous assessment: Protocol submission

• Biorefinery Product and Process Design
• Biorefinery Supply Chains
• Biorefinery Process Analysis
• Biorefinery Feedstocks
• Biorefinery Technologies
• Biorefinery Policy and Environmental Analysis

Blended learning

Final exam: Final written examination

• Development of enzyme technology and definitions of terms
• Biochemical basics: structure and function of proteins
• Enzyme production (fermentation, purification, stabilization)
• Modification of enzymes (targets, genetic methods, immobilization)
• Enzyme kinetics (reaction mechanisms and enzyme kinetics)
• Biochemical reaction engineering (reactors and process control)
• Enzymes in production processes (bulk and fine chemicals, antibiotics,...)
• Enzymes in diagnostics and biosensors (medical applications, enzyme assays, biosensors)

Blended learning

Final exam: Final written examination

• Overview of the methods of modeling and simulation of bioprocesses
• Chemometrics of biotechnological processes, i.e. mathematical and statistical methods
• Modeling and simulation approaches
• Quality by Design
• Process Analytical Technology
• Soft sensor
• Advanced Process Control
• Computational Fluid Dynamics (CFD)
• Digital Twins
• Group presentations and discussions about selected literature
• Exercises on a modeling topic

Blended learning (on-site & online)

- lectures, presentations & discussions

Final exam: Final written examination

• Practical business management concepts
• Development of a business plan
• Practical application of principles of business administration and cost accounting

Blended learning

Continuous assessment: preparation & presentation of a business plan

• Industrial property rights
• Dealing with patent specifications
• Scope of protection of patents
• Novelty and prior art
• Inventive step
• Other requirements for patentability
• Patent application procedure
• International patent protection
• Private patent law, in particular license agreements

Lecture

Continuous assessment: Intermediate written tests

term paper

oral examination

• Further development and elaboration of the research design in the form of an exposé for the Master's thesis
•  
• The Master's thesis must meet the requirements of a scientific or engineering thesis.
• The data collection is primarily experimental

research methodology:

The research methods used to complete the tasks and answer the questions are listed here.

The status of the methods (existing expertise): Which methods are already in place and which need to be established or even developed in the course of the work?

A series of studies should always be carried out on the basis of written methods and an experimental plan drawn up in advance. The results are continuously summarized in partial reports during the course of the project.

Literature research:

Examination of the latest scientific findings, technical developments and the current state of knowledge in the field of work.

Elaboration of a theme paper

Continuous assessment: Topic of the Master's thesis

• Basics of entrepreneurship
• Current challenges in the start-up sector
• Generating ideas
• Entrepreneurial spirit: forming start-up teams
• Elements of founding a company/building a start-up
• Error culture
• Pitch preparation

Blended learning

Project work in teams

Continuous assessment: Final presentation of the project work (pitches)

• Instructions and presentation of the Master's thesis with discussion on the planning, design, implementation, documentation and presentation of scientific or engineering work.
• Practice of the presentation to be given as part of the Master's examination
• What is particularly important when presenting a scientific paper?
• Receiving & giving feedback.

Presentations, discussion of a scientific article

Continuous assessment: Assessment of the given presentation (structure, slide deck, presentation style, timing).

The content of this course is the writing of a Master's thesis.

Many students develop Master's thesis topics, conduct research and write their Master's thesis in cooperation with or at the suggestion of companies. Around 20% find a topic with the help of their lecturers or supervisors.

The Master's thesis must be written in consultation with the UAS supervisor and after approval by the head of the degree program.

Continuous assessment: Assessment of the written Master's thesis according to a standardized catalog.

Examination interview on study-relevant content.

Self-study

Final exam: Presentation with assessment of the master´s degree thesis and general examination.