• 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.

• Students have the basic knowledge of materials and product quality, production technologies, medical applications and general challenges required for the manufacture of pharmaceuticals, and in particular biopharmaceuticals. The aim is to demonstrate the complexity of innovative therapeutic approaches from molecule discovery in the laboratory to application in patients based on the latest publications and "beyond textbook knowledge".

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

• Students are familiar with current topics in cell culture strain collection. They can plan and carry out practical experiments to characterize cell cultures, detect contamination with mycoplasmas and determine genetic drifts.

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

• Students can report on microbial strain improvement. They select suitable methods for strain improvement and can name the advantages and disadvantages of these methods. They can assign practically relevant parameters for strain improvement to the process conditions, propose measures to increase the productivity of microbial production processes, correlate them with process economic data and substantiate them with practical examples.

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

• Students can design and optimize methods of measurement, control and regulation technology for biotechnological plants. They can develop and operate automation processes for biotechnological plants.

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

• Students can apply the 1st and 2nd laws of thermodynamics to technical processes and abstract the thermodynamic models into technical processes.

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

• Students understand the definition of hygiene in the context of industrial hygiene and the pharmaceutical industry. They are able to understand hygiene as an interdisciplinary topic relating to the areas of personnel, buildings, materials, methods and equipment and can evaluate, delimit and describe the associated processes.

• The students acquire theoretical knowledge of germ inactivation, in particular inactivation using moist heat. The students can explain, interpret and characterize germ inactivation.

• Students can interpret, differentiate and evaluate the concepts of biological safety (containment and biosafety). They can interpret the legal regulations applied in Austria and are able to identify the corresponding requirements for microbiological work.

• Students will be able to apply, analyze, plan, evaluate and assess regulatory knowledge of the cleaning of surfaces in fermentation plants used in the biopharmaceutical industry which are in contact with the product.

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

• Students are familiar with the principles and concepts of basic operations in bioprocess engineering and are able to combine these into functional processes.

• Students can implement mathematical models for basic operations and apply these for the transfer of processes, scale-up and digitalization (digital twin).

Blended learning

Final exam: Final written examination

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

• Students are able to solve and interpret homogeneous and inhomogeneous linear differential equations of 1st and 2nd order with constant coefficients.

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

• Students can apply statistical methods in the context of biostatistics.

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.

• Students are able to plan, organize and evaluate basic statistical comparative studies. They can evaluate practical issues from quality-relevant processes, such as process optimization, process validation or process transfer, using the correct statistical methods.

• Students interpret the results of statistical evaluations and can present these results to stakeholders (non-statisticians) in an understandable way.

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

• Students can scale up a biotechnological process and implement it in practice. They can recognize and explain deviations and take countermeasures.

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.

• Students are able to design and practically carry out a fed-batch. They can operate an automated fermentation plant under aseptic conditions. They are proficient in monitoring important process parameters and can evaluate data and create protocols.

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

• Students can design biotechnological plants and realize them in a team.

• Students are able to implement technical projects independently and systematically.

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

• Students combine thermodynamic processes with energy systems (refrigeration technology, energy technology) and can apply these to technical applications (heat pump).

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.

• Students can apply standards and regulations according to the principles of good manufacturing practice to the biotechnological process. Furthermore, students are able to create, check and maintain quality assurance documents in the production process.

• Students will be able to use the seven quality tools and statistical process control (SPC) to monitor and improve process quality, communicate complex quality management topics in an understandable way and conduct training courses for various target groups.

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

• The students know the basics and objectives of risk management and are able to define the concept of risk and the relevant terminology, as well as assess risk analysis methods and identify their strengths and weaknesses. They will also be able to select suitable methods for their future tasks in terms of suitability, effort and costs/benefits.

• Students can apply the methods mentioned to practical problems. Students can select the appropriate methods for the respective tasks with regard to suitability, effort and costs/benefits.

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

• The students understand the basic principles of qualification and validation. This includes the planning phase, device qualification, validation of analytical methods, process validation as well as cleaning and sterilization validation.

• The students have acquired knowledge of validation documentation, such as the master validation plan, validation regulations and validation reports.

• Students are able to plan and manage validation projects and are proficient in the practical implementation of validation projects (device qualification, cleaning validation, sterilization validation).

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

• Students are able to differentiate between the terms "bio-based", "biodegradable" and "compostable" and classify materials accordingly. They will be able to name the most important bio-based and biodegradable plastics and describe their manufacturing processes and properties. They are also able to critically assess current developments and discussions on bio-based materials. They are familiar with the main 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

• Students can carry out independent data analyses in R.

• Students know visualization methods and can visualize their data in a meaningful way.

• The students have dealt with the use of artificial intelligence in data analysis.

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).

• Students are able to plan, organize and evaluate multi-factorial experimental designs for a practical problem. They understand the differences between the individual calculation methods with regard to their strengths and weaknesses and apply the correct method to the respective case.

• In addition, students shall be able to interpret the results correctly and convert the statistical conclusions into practical solutions regarding optimal process settings.

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

• Students know and understand the most important methods and procedures in protein purification as well as the calculation of processes and process design.

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

• Students can carry out a practical purification of a protein (protein of interest) and select, calculate, develop and implement the necessary basic operations (centrifugation, filtration, chromatography). Students can create a hybrid model of a process and use it to solve optimization problems.

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

• Students can give presentations on biorefineries. They can assign practically relevant processes to supply and value chains, develop technical and economic feasibility studies for production processes and substantiate them with practical examples.

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)

• Students are able to understand the biochemical principles of enzymes and can apply their knowledge to solve practically relevant cases. They understand the mechanisms of enzymatic reactions and can use the influencing process parameters to calculate and design enzymatic processes and process control. Students are able to understand the differences and similarities between inorganic, organic and biochemical catalysis.

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

• Students apply various methods for the representation, modeling and simulation of special aspects of bioprocesses.

• Students have familiarised themselves with the use of artificial intelligence for the creation of models and simulations of bioprocesses.

• Students have familiarised themselves with the use of artificial intelligence for the creation of models and simulations of bioprocesses.

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

• Students learn about and understand business contexts.

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

• Students have a basic understanding of intellectual property and patent law.

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.

• Students demonstrate their ability to systematically investigate an issue, work on a problem in depth using scientific methods and procedures, draw conclusions and describe them in a written paper.

• The Master's thesis demonstrates the student's ability to work on a research question independently and adequately in terms of content and methodology and to derive new findings.

• Students routinely apply techniques of critical and self-regulated reading and writing. Students reflect on the research methodological approaches used in the context of the research question and the intended research objectives.

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

• Students are familiar with terms from the field of entrepreneurship and idea generation and can apply the associated tools theoretically and practically.

• Students are able to carry out the first steps of founding a start-up from the beginning to the presentation of the business idea in the form of a pitch.

• Students can recognize and apply team structures.

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.

• After completing this course, students will be able to effectively summarize and present their Master's thesis. They know the basics of presentation structure, presentation of results, presentation style and adherence to time limits.

• Students are able to summarise and critically evaluate scientific literature.

• At the end of the lecture students are able to evaluate a scientific topic.

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.

• Students are able to write an academic thesis at Master's level.

• Students work independently on scientific research questions and choose appropriate methods to derive new findings.

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.

• Students demonstrate their cross-linked knowledge of biotechnology in an examination discussion on the Master's thesis and course-related content.

• Students will be able to present projects.

Self-study

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