The module aims to illustrate to learners the structure and function of macromolecules of the cell and how they integrate into cellular function.

1. Explain the function of macromolecules in the cell.

2. Describe mammalian cellular energetics.
3. Describe the action of enzymes and discuss factors that affect enzyme kinetics.

4. Outline the organisation of nucleic acids in the cell.
5. Illustrate the cell cycle.

6. Relate some applications of molecular biology.

7. Perform and report on, biochemical laboratory experiments and communicate information accurately and effectively using written, visual and numeral forms.

The aim of this module is to introduce the student to both the theoretical and practical aspects of basic microbiological techniques required to safely handle, investigate and manipulate micro-organisms in laboratory setting. Students will be provided with the opportunity to acquire knowledge of the subject matter through a variety of lecturer led activities and self-directed study. Such activities will include traditional and interactive lectures, problem solving and revision tutorials and laboratory practical classes. Theoretical and practical problems will be employed to assist students in the development of their analytical and problem solving capabilities.

1. Understand that microorganisms comprise a diverse range of organisms that includes bacteria, fungi, protozoans, algae, viruses and sub-viral particles.
2. Understand microbial structural diversity and classification.
3. Be aware of microbial physiological diversity which is reflected in a range of microbial activities in nature, in their importance in biotechnology and in health and disease. Understand the theoretical and practical principles underpinning a diverse range of methodologies aimed at controlling microbial growth.
4. Be capable of manipulating and interpreting numerical data relating to microbiological analysis.
5. Understand the importance of, and work in compliance with, health and safety policies and good laboratory practice as it pertains to microbiology laboratories.
6. Demonstrate an awareness of key principles of Microbiology and be able to explain major microbiological concepts by demonstrating a capacity for critical scientific analysis of relevant issues.
7. Be able to design and execute experiments, systematically collect and analyze data, identify sources of error, and interpret the results and reach logical conclusions. They should also have a basic understanding of safety issues.
8. Operate basic laboratory instruments used in microbiology practical experimentation.
9. Apply the scientific method by stating a question; researching the topic; determining appropriate tests; performing tests; collecting, analyzing, and presenting data; and finally proposing new questions about the topic.
10. Be able to (1) differentiate between fact and opinion, (2) recognize and evaluate author bias and rhetoric, (3) develop inferential skills, (4) recognize logical fallacies and faulty reasoning, and (5) make decisions and judgments by drawing logical conclusions using sound quantitative and statistically-based reasoning.
11. Understand and appreciate the value of cooperating and working effectively with peers and be able to demonstrate a commitment to the process of developing such skills.

In this module the student will explore ethical issues in modern medical biotechnology. Students will study the challenging questions that arise at the intersection of medicine, genetic engineering, technology and ethics. The module will introduce the ethical principals and theories which inform, guide and justify best practise in biomedical research. Students will employ moral reasoning to identify potential ethical issues in 'real life' scenarios. They will deepen their understanding of the ethical issues underpinning modern medical biotechnology. The module will provide knowledge on the regulatory frameworks and governance of research ethics. Students will cultivate strategies for dealing with likely challenges and issues they could face when studying or working in medical biotechnology and biomedical science.

1. Demonstrate knowledge and understanding of ethical issues in medical biotechnology.
2. Identify moral aspects of various issues in contemporary biomedical science.
3. Communicate ethical issues in a calm, rational and balanced manner in both written and oral formats.
4. Differentiate between reliable scientific reports and sensational media communications.

5. Interpret existing frameworks in Ireland and the EU regulating medical biotechnologies.

The course introduces the student to the basic elements of chemical analysis from sample preparation to the collection and statistical evaluation of analytical data. The course deals with aspects of volumetric analysis including the application of primary and secondary standards. The course also provides both a theoretical and practical introduction to several instrumental analysis techniques including infrared spectroscopy, ultraviolet -visible spectroscopy, atomic absorption, liquid and gas chromatography.

1. Define basic analyticaltheory and standard/sample preparation.

2. Demonstrate an understanding of the underlying concepts and principles of a range of instrumental and classical methods of analysis.

3. Demonstrate competence in the practical application ofselected instrumental and classicalmethods of analysis.

4. Calculate chemical compositions from raw analytical data in a variety of units and evaluate the reliability of analytical data using simple statistical and quality control techniques.
5. Communicate and report the findings of experimental analysis in an individual and /or group format taking into consideration good laboratory practice.

This is an introductory module covering concepts in Materials Science and Materials Engineering that may be of relevance to biomedical science and medical biotechnology. The content is framed in the context of the selection and suitability of materials used in biomedicine and in medical devices.

1. Define basic concepts and explain general principles of materials science.

2. Describe, discuss and use examples of how the structure of materials influences the properties and performance of materials and apply knowledge of basic material science to identify material properties that are critical for metallic, polymer and ceramic biomaterials, or their combination.
3. Explain the operation of a range of instruments in materials testing and examination.

4. Report the performance of a materials science experiment and/or test in a prescribed manner, presenting results, processing and interpreting data, and deducing informed conclusions.
5. Research, analyse, interpret and report information relevant to function and construction of biomedical devices and describe the relevance of the choice of biomaterial for given applications.

Further development of mathematical techniques necessary for scientists

1. Use the laws of logarithms to solve complex equations, analyse exponential data and plots

2. Useexponents to perform population analysis and determine thehalf life and cell doubling times of natural growth and decay.

3. Perform probability calculations of single and multiple events and usenormal distribution to determine biological probabilities.

4. Perform calculations with simple matrices, solve systems of simultaneous equations using matrix methods.

5. Evaluate integral calculus problems and determine the area under various curves

The aim of this module is to provide students with an understanding of the basic principles underpinning molecular biology. The module will introduce students to DNA and RNA structure, DNA replication, transcription and translation. Students will explore practical applications of molecular biology, some of which will include Agarose Gel Electrophoresis, Nucleic Acid Extraction, PCR, Cloning and Restriction Digestion. This module will also introduce students to the analysis and manipulation of nucleic acids and plasmid DNA.

1. Compare and contrast nucleic acid structures and describe some techniques used in their analysis.

2. Describe the mechanism of DNA replication.

3. Elucidate the processes involved in gene expression and regulation.

4. Summarise the main steps in the Polymerase Chain Reaction.

5. Appreciate the complexity of gene cloning and depict the key steps in the process.

6. Interpret and analyse bioinformaticdata.

7. Perform key molecular biology techniques in a laboratory setting.

8. Analyse, collate and report on experimental data generated in practical sessions.

This module is designed to introduce medical pharmacology to students who are pursuing degrees in scientific fields. Topics will include the basic principles of pharmacology and several major classes of therapeutic agents, with attention to their mechanisms of action by which drugs act and relates these to their overall pharmacological effects and clinical uses.

1. Gain a thorough understanding of Pharmacodynamics, the basic principles underlying drug action in the mammalian body and the Pharmacokinetics effect of the body on the drug molecule.
2. Describe the endocrine, nervous and excretory systems and the mechanisms of drug interaction with these systems.
3. Detail the MOA of Diuretics and Drugs Affecting Renal Function, Cardiovascular and Respiratory Pharmacology.
4. Describe the key factors involved in drug-receptor interaction and intracellular signalling mechanisms.
5. Detail the methods of Chemotherapy and modes of activity/selectivity, Structure Activity Relationship, Describe the mechanisms of transfer and of manipulation of the genetic elements involved in antibiotic resistance.
6. Demonstrate research techniques for obtaining drug information from drug references and other sources.

The course introduces students to the immune system as an innate and adaptive defence system that recognises invading pathogenic organisms and mounts a response to eliminate or neutralise foreign infectious agents. Students will be introduced to the molecules, the cells and organs, and the processes involved in host defence against infection. An overview of basic principles, concepts, and techniques used to assess immune status will be presented.

1. Be familiar with the human immune system, including both cell-mediated and humoral responses.
2. Understand the distinction between the specific and non-specific response and how they function together.
3. Understand the structure, function and types of antibodies.
4. Be familiar with the different types of T cells, their response to antigens and relationship to B cells.
5. Understand the causes and consequences of immune system dysfunction (including Acquired Immune Deficiency Syndrome).
6. Be aware of current methodologies in the area of immunotherapy immunoassay and immunodiagnosis.

The aim of this module is to introduce the student to both the theory and practical aspects of microbiology related to the production of a range of biomedical products, including pharmaceuticals, medical devices and immunodiagnostic materials. Students will be provided with the opportunity to acquire knowledge of the subject matter through a variety of lecturer led activities and self-directed study. Such activities will include traditional and interactive lectures, problem solving and revision tutorials and laboratory practical classes. Theoretical and practical problems will be employed to assist students in the development of their analytical and problem solving capabilities.

1. Understand microbial ecology and its relationship to biomedical products manufacture.
2. Understand the importance of environmental monitoring as a regulatory and quality control requirement.
3. Collect, manipulate and interpret numerical data relating to microbiologicalanalysis.
4. Understand the importance of, and work in compliance with, health and safety policies and good laboratory practice as it pertains to microbiology laboratories.
5. Be able to design and execute experiments, systematically collect and analyze data, identify sources of error, and interpret the results and reach logical conclusions.
6. Operate basic laboratory instruments used in industrial microbiological monitoring.
7. Cooperate and work effectively with peers and be able to demonstrate a commitment to the process of developing such skills.

The animal cell culture module introduces the basic concepts and issues pertaining to the culture of animal cells. The module begins with a historical and applications-driven view of the topic and the types of cells which are cultured in vitro. The module outlines the growth requirements of cells in culture including the various media which may be used and how cells are grown and stored by cryopreservation. Issues relating to chemical and biological contaminations which may impact on cell culture are described. The regulations pertaining to genetically modified organisms which are pertinent to the biopharmaceutical industry are discussed. The module includes a comprehensive laboratory element introducing basic cell culture preparation, growth, storage and analysis of cell culture.

1. Explain, using appropriate technical terminology, what is meant by animal cell cultureand outline the key applications.

2. Describe the growth requirements and characteristics of cells in culture.

3. Outline the various growth platforms which may be used in cell culture.

4. Explain, illustrate and/or demonstratehow to establish, passage, freeze, recover and maintain selected cell lines.

5. Recognise and evaluate the QC issues and GMP requirements pertinent to cell culture laboratories.

6. Evaluate contamination and biosafety issues.

7. Execute laboratory protocols which are used in routine animal cell culture.

8. Analyse and report experimental concepts and data.

This course is designed to provide an introduction to a range of statistical tools of relevance to scientists. Specific topics include an overview of statistical distributions, significance testing, uncertainty determination, linear regression and experimental design. The application of statistics for quality control and practical experience in the application of statistical features in the widely available Microsoft Excel is particularly emphasised.

The teaching methods used will be a combination of lectures, self-study, labs, tutorials, and any combination of discussion, case study, problem-solving exercises and computer-based learning.

1. Describe basic statistical terms which are of relevance to the area of analytical science.

2. Graphically display and numerically summarise data using appropriatetables, graphs and measures of centre, spread and position.

3. Explain and apply concepts of basic probability including, conditional probability, Bayes’ theorem, independent events and counting formulae;

4. Make interferences about population parameters using sample statistics using confidence interval estimates and tests of statisticalhypotheses

5. Describe the application of statistics tosampling, quality control, analytical method validation andexperimental design.

6. Use an appropriate method for analysingrelationships between variables in a dataset

This course aims to provide the student with a broad understanding of the various medical devices available for the treatment and prevention of diseases, their control and regulation and their modes and methods of manufacturing and finishing. It also aims to provide an overview of the medical device industry both globally as well as nationally, ethical issues and the role the industry plays in society.

1. Demonstrate a knowledge and understanding of the medical device industry, the principal companies involved and the main product types being manufactured, evaluate ethical questions and societal impact of the industry.

2. Explain the various principles and practices involved in the control and regulation of the medical device industry both in Europe and the USA.
3. Evaluate current and future manufacturing processes for polymer based, metallic, ceramic and composite based medical devices.

4. Describe the support activities involved in medical device manufacturing, such as sterilization, labelling and packaging.

5. Communicate and critique scientific data relating to medical device manufacturing and evaluate current trends and future research areas.

Learners will acquire a knowledge and understanding of the research environment and methods of dissemination and communication in academia and industry. This will include: research development; design; literature searches; peer review and scientific communication through written and oral media. Upon module completion students will be equipped with the core principles of basic research methodology design and implementation. Students will also learn of the regulatory bodies whose remit includes the licensing and regulation of research and biomedical product development and will be able to disseminate information accurately and appropriately.

1. Communicate with scientific peers effectively through written and oral media
2. Develop competency in a scientific interview environment
3. Understand the process and the principles of research design and execution in the context of biomedical science

4. Design logical and defensible basic research strategies and appropriate data collection regimes
5. Search and review scientific literature effectivelyand understand the process of peer review

6. Know the basics of the rules and regulations governing research
7. Understand the concepts of innovation, intellectual property and patenting

This module aims to study the structure and function of proteins in greater depth than the basics covered in a Biochemistry module. Protein primary, secondary, tertiary and quaternary structure will be examined using non traditional methods.There is a heavy emphasis on using bioinformatics and data mining technologies to gain an understanding of protein design and genetic manipulation.

1. List and explain the major bond types which accompany peptide and protein formation and understand what conditions need to be maintained to preserve their structure.

2. Illustrate and distinguish between the main secondary, tertiary and quaternary structures which are formed during protein synthesis and also the role and significance of post translational modifications.

3. Examine the key functions of proteins in cells and tissues and the characterize the role of proteins in human disease.
4. Demonstrate an ability to search and compare DNA and protein sequences and structures fromsequencing databasesusing data mining techniques.

5. Demonstrate an ability to write industry standard reports with particular emphasis on effective referencing and prioritisiation/selection of relevant material.

This module introduces EMA/EU/Irish legislation for medicinal products. It also introduces Eudralex Volume 4, ICH, GMP, Auditing, relevant to the Pharma/Biomedical and Medical Device industry.

1. Demonstrate a detailed knowledge and understanding of the main US and EU institutions, legal instruments, ICH process and workings of EMA in relation to medicinal products.

2. Integrate knowledge and understanding of Common Technical Document (CTD), variations procedures and Clinical Trial Legislation to evaluate relevant case studies.

3. Source and evaluate guidance procedures and directives currently regulating good manufacturing practices (GMP).

4. Demonstrate knowledge of the ICH Q9 and Q10 guidance documents as relating to QRM and PQMS for a licensed production facility.

5. Interpret and understand the relevance of auditing as a means of monitoring the production of safe and efficacious pharmaceutical and medical device products in a GMP environment.

6. Source, interpret and apply GMP principles to different case scenarios and identify potential issues that would result in implementation of Corrective and Preventative Actions.

This subject is designed to introduce the students to compatibility issues which arise from the use of implants and medical devices. The subject emphasises the properties of biomaterials which may result in incompatibility within the recipient. The subject studies the implant host interface and the role this plays in determining biocompatibility. The module defines and describes the major adverse host responses to implanted biomaterials and how they may be controlled. The module also encompasses biomaterial testing in theory and practical elements. The importance of sterility and product standards and regulations is also addressed.

1. Outline materials used in implant devices and how they impact on biocompatibility.

2. Describe the environmental and biological responses to implanted devices.

3. Provide an overview of the importance of sterilization, regulation and standards to the medical device industry.

4. Outline the testing of implants for biocompatibility.

5. Execute laboratory assays which are used to determine biocompatibility.

6. Analyse and report experimental concepts and data.

The immunodiagnostics module introduces students to the application of antibodies for the purpose of diagnosis. The structures of antibodies and antigens are introduced and the different classifications of antibodies (such as mono- or polyclonal) and their relevance are discussed. Tissue type and sampling in immunodiagnostic testing is outlined along with antibody conjugation, types of output, signal detection, dynamic range and signal amplification. Antibody validation is addressed in relation to titering, specificity and sensitivity issues for testing. Common applications, assay types and future applications are also discussed.

1. Defineimmunodiagnostics and relate the structure, biochemistry and production of Immunoglobulins and antigens to testing.

2. Describe the methods of antibody conjugation, signal outputs,signal amplification and patient sampling commonly used in immunodiagnostictesting.

3. Recognise and evaluate the QC issues pertinent to immunodiagnostic techniques and the interplay between dynamic range, sensitivity and specificity.

4. Identify applications ofimmunodiagnostics and detail current and future applications.

5. Demonstrate key immunodiagnosticconcepts and execute common laboratory assays, which are used in immunodiagnostics.

6. Analyse and report experimental concepts and data.

This module aims to provide the student with a broad understanding of the main support service areas involving both facilities and utilities that underpin the modern biopharmaceutical manufacturing industry.

1. Outline the main elements and features of facilities and utilities relating to the modern biopharmaceutical industry.
2. Understandthe main facility design concepts including cleanroom technology for Biopharmaceutical Processing.

3. Describe the key elements of a water treatment system for Biopharmaceutical Processing.
4. Describe the key principles involved in cleaning and sterilisation systems for Biopharmaceutical Processing.
5. List and describe other important utility systems for Biopharmaceutical Processing.
6. Communicate and explain scientific data relating to facilities and utilities.

The aim of this module is to review current knowledge, underpinning principals and recurrent themes in microbial biotechnology. Microorganisms are fundamental to many industrial processes and students studying this module will gain an understanding of the use of bacteria, yeast, fungi and algae in the production of valuable commodities. The module describes the use of microorganisms in biotechnology, the application of microbial enzymes in industry, the use of recombinant DNA in the production of products, fermentation processes, and downstream processing.

1. Evaluate the potential for microbial cells in biotechnology.

2. Review the molecular methodologies for engineering microbes for use in thebiotechnology industry.

3. Compare and contrast industrial fermentations.

4. Discussthe fundamental characteristics of various downstream processes used in the purification of biotechnological products.

5. Demonstrate proficiency in the performance of a variety of relevant laboratory techniques.Analyse, collate and report on experimental data generated in practical sessions.

This module is an introduction to the interdisciplinary field of advanced therapy medicinal products (ATMPs), which encompasses tissue engineering, and cell and gene based therapies. The latter are rapidly emerging as therapeutic approaches to treating disease / diseased tissues and genetic disorders in the biotechnology industry. This course will introduce advances in the fields of cell biology, material science, cell based medicine and gene based medicine and their relationship towards developing novel therapies.

1. Explain the fundamental principles in developing cell, gene and tissue engineered therapies.

2. Define the principal applications of advanced therapy medicinal products (ATMPs).

3. Analyse, evaluate and draw conclusions from data obtained in problem solving exercises.
4. Communicate effectively with peers on multi-disciplinary teams to attain a common goal.
5. Formulate and communicate judgements with regard to the ethical issues surrounding the use of stem cells, gene therapyand tissue engineered therapies to treat human diseases and disabilities.