This module examines the chemistry of life processes. Key chemical concepts that apply to biological systems are investigated, including the types of chemical bonds, the structure of water (an almost universal solvent in biochemical processes), the First and Second Laws of Thermodynamics, and the basic principles of acid-base chemistry.

The structures of the four main types of macromolecules found (with minor variations) in all living organisms are described and the close relationship between their respective structures and functions are examined. Various methods used to quantify and analyse proteins, polysaccharides, lipids, and nucleic acids are introduced and the theoretical bases of chromatographic and electrophoretic techniques, respectively, used in studying, developing, and manufacturing protein-based therapeutics are described.

The structures and functions of vitamins and their biological functions are overviewed and the function of enzymes as biological catalysts is evaluated in terms of structure, function, and mechanism of action.

The module also describes key metabolic concepts such as the generation of energy from the breakdown of glucose and other metabolites, along with an overview of the associated processes of tryacylglycerol, glycogen, and protein metabolism.

Students develop their practical skills by performing a range of laboratory experiments that focus on the purification and qualitative/quantitative analysis of macromolecules, the application of chromatographic techniques to the separation of biomolecules, and the analysis of enzyme activity and inhibition.

Sustainability is embedded in the biochemistry module. The use of paper is minimised by using soft copies of notes and continuous assessments. Signage is used in the laboratory to decrease energy consumption (i.e. turn off lights, close the fume hoods, turn off appliances). The use of washable and reusable glassware is encouraged, and plastic pipette tips are washed are reused. Water is conserved through vigilance in turning off taps and ensuring that there are no obvious water leaks.

1. Describe the key chemical concepts that apply to biological systems (chemical bonds, the structure of water, the First and Second Laws of Thermodynamics, acid-base chemistry) and their application.

2. Identify the different types of macromolecular and their constituent subunits, describe their structures and structure-function relationships with reference to specific examples

3. Describe the structure and mechanism of action of enzymes, explain the role of cofactors in enzyme reactions with reference to specific examples and explain the different types of enzyme inhibitors and how they may be identified.

4. Examine key metabolic processes in the metabolism of carbohydrates, proteinsand lipids, discuss the importance of metabolites in the generation of energy and the processes involved, and the role of metabolites as intermediates in biosynthetic reactions.

5. Conduct all laboratory work in compliance with relevanthealth and safety legislation/guidelines, and understand the relevant biological, chemical and physical hazards associated with working in the laboratory, apply appropriate standards and procedures for risk containment and be aware of risk assessment.

6. Use a range of analytical instruments, equipment, procedures, and techniques to prepare and carry outlaboratory experiments related to biomolecules and process, analyse, interpret, and documentthe results of qualitative/quantitative assays usingreference standards/standard curves/specifications.

Analytical Techniques 2.1 module combines theory with practical work so that the student has a comprehensive knowledge of spectroscopic and chromatographic techniques for qualitative and quantitative analysis of organic and inorganic chemical entities. From the theory the student learns the basic methods of spectroscopy which include uv/visible radiation, fluorescence, atomic absorption, flame absorption & infra-red spectroscopy. The student also learns the basic methods of chromatography which include gas chromatography, high performance liquid chromatography, thin layer, ion- exchange, column and paper chromatography. Through practical work the student learns how to follow procedures, to prepare samples for analysis, preform dilutions, use mathematical methods to process analytical data, obtain quantitative results and report results in a proper manner.

1. Display a knowledge of the basic theoretical principles underlying methods of spectroscopic and chromatographic analysis.
2. Follow procedures and prepare samples for analysis by spectroscopic and chromatographic techniques.
3. Operate a wide range of analytical instrumentation under supervision.
4. Process analytical data and obtain quantitative results.
5. Write reports using mathematical methods.
6. Assess the validity of the results.

Introductory module on the characterization of DNA & RNA and their manipulation and analysis.

1. Describe the structure, replication, transcription, and translation of prokaryotic and eukaryotic DNA

2. Describe the nature of key manipulative enzymes that are used to analyze DNA and RNA sequences.

3. Recognize the equipment, reagents and protocols that are required to target, to digest, and to amplify DNA/cDNA-RNA.

4. Undertake general calculations for reagent preparation from stock samples.

5. Apply theory-based knowledge to process and analyze DNA gel bands and DNA sequences in-silico using a suite of online tools.

6. Use appropriate reagents & equipment to quantify, visualize, and manipulate DNA samples.

The module encompasses analysing data, summarising it concisely, modelling it for presentation it and extracting all significant information therefrom. Skills in Interpreting mathematical statements will be imparted. Following an introduction to basic statistics a range of statistical tests will be studied and the best available statistical test(s) will be employed to arrive at decisions based on the data presented. Suitable theoretical models will be proposed to explain observed measurements.

1. Record, model, present, analyse and interpret experimental data performing logarithmic transformation and regression when appropriate

2. Suitably manipulate and transform equations in order to simplify the process being described and to extract desired parameters.
3. Calculate the probability of an event and the expectation from a given distribution

4. Implement various mathematical and statistical operations, tests and computations for making quantitative decisions about a process or processes.

This module will provide the student with an introduction to Quality Management. The module will equip students with a number of tools that are essential components of a good manufacturing practice compliant company. Students will learn how to draft a Standard Operating Procedure and populate a CAPA form based on a sample Non Conformance.

1. Discuss the role and function of Quality within the laboratory and Industry, and differentiate betweenQAand QC.

2. Outline the role and function of GLP, GCP, GMP in the context of the drug development life cycle.

3. Construct Standard Operating Procedures, non-conformance reports and CAPAs in line with regulatory guidelines.

4. Appreciate the growing dependance on automated systems, software anddata in a manufacturing context and the importance of equipment and automated system validation and data integrity.

5. Identify the responsibilities of the employee and employer with regard to health and safety in the laboratory and industry.
6. Recognise opportunities for more sustainable practice within industry,specifically with respect to electronic record and data management.

This module explores some of the fundamental aspects of Microbiology with a strong emphasis on laboratory skills associated with aseptic technique and the culture of microorganisms. The module will incorporate bacterial culture techniques, preservation, staining & observation. The module will also introduce methodologies associated with bacterial enumeration.

1. Successfully stain and visualise microorganisms using the compound microscope.
2. Isolate, purify and preserve bacterial cultures.
3. Prepare different media types and utilise same for culture of microorganisms.
4. Enumerate bacterial cells using a viability count method.
5. Perform aseptic technique with emphasis on liquid and solid culture inoculations.
6. Describe different methods that are used to control the growth of microorganisms.
7. Discuss the importance of metabolism in the generation of energy and synthesis of important compounds in bacterial cells.

Semester-long module will consist of two hours of theory and two hours of practical work per week.

Analytical Techniques 2.2 module combines theory with practical work covering the basic techniques used in electrochemical and water analysis. The student will use pH and conductivity meters, various ion selective electrodes and employ use of titration to confirm the analytical methods.

Through the practical work the student learns how to follow procedures, to prepare samples for analysis, use mathematical methods to process analytical data, obtain quantitative results and report results in a proper manner.

1. Understand the basic theory of instrumental methods in electrochemistry.
2. Operate a range of electrochemical instrumentation.
3. Prepare and use samples in qualitative and quantitative analysis.
4. Determine the composition of real samples.
5. Select the correct analytical technique for analysis.
6. Assess the validity of experimental data.
7. Compare test results with expected results.
8. Appreciate the importance of applying specific procedures in electrochemical and water analytical analysis to ensure reliability and accuracy of any data obtained and reported.

This module predominantly focuses on applications associated with microorganisms. The module provides an overview of commercial products manufactured using microorganisms. Environmental applications of microorganisms will also be studied, and fungal and viral culturing/enumeration methods will be performed as part of laboratory practical sessions. Microbial genetic transfer systems will also be investigated.

1. Perform membrane filtration on a water sample to test for the presence of an indicator microorganism.
2. Discuss the importance of bacterial taxonomy and the multiple methods used for identification and description of new species.
3. Generate a growth curve using a bacterial batch culture to assess the different stages of bacterial growth.
4. Discuss industrial applications associated with the use of microorganisms.
5. Determine viral titres using bacteriophage and appropriate host cells.
6. Successfully culture moulds using appropriate media types and visualise using a stereoscopic microscope.
7. Describe the different methods of genetic transfer used by bacterial cells.

This module provides a scaffold that students will use to connect the various concepts in the immune system and the individual components and terminology involved. It begins by introducing students to the organs, cells & molecules of the immune response. It describes the primary & secondary lymphoid organs, hematopoiesis, and the mechanisms of cell synthesis and cell death.

This is followed by an overview of the key roles of the interconnecting innate and adaptive immune systems and how they collaborate to protect the body from pathogens. The molecular and cellular mechanisms of innate immunity and the humoral and cell-mediated branches of the adaptive immune response are described. The activation of B and T lymphocytes is explained along with the regulatory role of cytokines in these processes. Antibody structure and the generation of antibody classes through gene rearrangement and class switching are evaluated, along with the roles of different antibody classes in binding antigen and mediating immune effector mechanisms such as complement activation, antibody-dependent cell-mediated cytotoxicity, and hypersensitivity.

The module concludes with an introduction to diagnostic & therapeutic antibodies and vaccines.

1. Describe the structures and functionsof the organs, cells, and key molecules of the immune system and the interactions between them.

2. Explain the key features of theinnate and adaptive immune responsesand describe the adaptive immune response to pathogens and following vaccine administration.

3. Distinguish between the activation of B and T cells, outline the antigen processing pathways involved, and demonstrate the involvement of cytokines in these processes

4. Give examples of the different classes of antibodies – describe how they are generated, their structure, and their respective roles in mediating biological effector functions and in hypersensitivity reactions

5. Apply and condense the technical knowledgeacquired in the preparation of posters andpresentations,in the completion of assessments, and in the development of further knowledge, skills & abilities.

This module describes the major advances in 21st century molecular biology approaches to the fields of clinical diagnostics, nucleic acid therapies, and online fundamental bioinformatic resources applying to these disciplines. General gene cloning approaches in the initial has of biopharmaceutical production are also described. A suite of appropriate wet and dry laboratory techniques will be included.

1. Describe the genomic features that underlie clinical conditions and serve as targets for biopharmaceutical development and interventions.

2. Describe the epigenome, its role in phenotype expression, and the external factors that can detrimentally alter it during ones lifespan and through future generations.

3. Appreciate the ever-increasing influence of Next Generation Sequencing (NGS) methodologies in medical diagnostics and the subsequent development of precision clinical therapies.

4. Appreciate the importance of modern gene manipulation tools, with emphasis on CRISPR.

5. Use appropriate bioinformatics tools and web sites to examine and understand clinical conditions in detail.

6. Use a variety of molecular biology laboratory instruments and associated protocols that are in general use in routine and clinical laboratories.

This module introduces the student to the main pollutants affecting marine and freshwater environments and describes their impacts on aquatic communities, as well as human health. National water quality data will be presented to highlight current threats to water quality in Ireland and Europe, and pollution control methods will be introduced. The student will acquire appropriate techniques for detecting pollutants and monitoring their effects. They will learn how to assess the toxicity of a potential pollutant including the role of experimental design, evaluate environmental risk associated with pharmaceuticals and will be trained in the use of biological indicators of water quality. In addition, statistical concepts for assessment will be introduced. As required, the module will address legislation pertaining to the evaluation of environmental quality and of management practice.

1. Identify potential pollutants and describe their effects on aquatic ecosystems.

2. Evaluate problems caused by pollution of water used for water supply.

3. Identify and apply appropriate biological, physical, and chemical methods for assessing water quality.

4. Describe methods for the prevention and mitigation of water pollution.

5. Evaluate the environmental risks associated with biopharmaceuticals.

6. Have a knowledge of legislation pertaining to pollution monitoring and assessment, including national, European and international legal frameworks.

This module focuses on the application of spectrophotometric methods to the identification and quantification of pharmaceutical substances. Atomic absorption and emission techniques as well as molecular absorption and emission techniques are studied in the context of providing quality control methods for drug substances and drug products. Structural techniques such as IR and NMR are also examined as tools to aid in identification of active ingredients as well as impurities or degradants. The analysis of various pharmaceuticals is carried out in the laboratory to practically illustrate the theory and enable the student to develop their analytical laboratory skills.

1. Describe and explain the operation of flame and graphite furnace atomic absorption as well as associated methods such as the hydride or cold vapour method.
2. Discuss emission methods such as ICP, and outline sample preparation methods for either absorption or emission analysis.
3. Identify common chromophores in pharmaceutical substances and discuss the use of UV/VIS spectrophotometry for calculation of drug concentrations, drug release, drug solubility etc. in either single or multicomponent formulations.
4. Explain the relationship between molecular structure and fluorescence and use data from fluorimetric measurements for quantitative pharmaceutical analysis.
5. Discuss the role of both mid IR and NIR in quality control of pharmaceutical substances.
6. Discuss the use of NMR and MS in the characterisation of structures of pharmaceutical substances.
7. Set up and use spectrophotometric instruments to examine a variety of pharmaceutical substances and use data obtained for either qualitative or quantitative analysis of such substances.

This module will provide learners with a knowledge of the applied aspects of enzymology and immunology. Applied Enzymology builds upon the principles of enzyme catalysis, enzyme inhibition, sources of enzymes and their purification. It also describes the industrial and clinical applications of enzymes and the principles of enzyme technologies. The learner will gain practical experience in the extraction of enzymes and their purification and quantification using enzyme assays. Applied Immunology will focus on antibodies and their development plus their applications in Immunoassays (IAs). The learner will gain practical experience in performing immunoassays which plays a prominent role in healthcare and industrial settings as these assays can provide an early and precise detection of analytes/biomarker in clinical samples.

1. Classify enzymes, identify the factors that influence the rate of catalysis, explain and perform a number of enzyme-based assays.

2. Describe how the Michaelis- Menten kinetic constants are derived and calculated, mechanisms of enzyme catalysis and enzyme inhibition.

3. Extract an enzyme from a biological source, purify using low level purification techniques and calculate purification parameters such as% recovery, specific activity and purification factor.

4. Describe the major applications of enzymes in analytical, clinical, industrial environments and identify the technology and future prospectives and trends in regard toenzymology.

5. Explain and outline the main principles of immunochemistry such as the nature and interactions of antigen/antibody .

6. Identify the factors involved in antibody development and their potential applications in immunoassays.

7. Classify immunoassays, show knowledgewith regard to labels, detection systems, platforms andperform a number of immunoassays.

8. Write scientific reports and interpret analytical data from enzyme assays and immunoassays.

This module is designed to give learners a clear understanding of the role of microbiological quality assurance and quality control, particularly as applied to the (bio)pharmaceutical and medical device sectors.

It will provide learners with the information and laboratory skills to enable them to recognise the role of the microbiologist in the production of safe and wholesome products and to participate effectively in Quality Assurance teams in industry.

It will equip learners with the skills necessary to design appropriate QC testing protocols for raw materials, waters, in-process and finished products. Learners should be able to adopt an advisory role in situations relating to Microbiological Quality Control by recommending suitable materials, equipment and procedures. 'Laboratory practical's will be delivered/rolled out to students with a lecturer led emphasis on sustainability. Students will be asked to reflect on how they may incorporate sustainability into their practical work when preparing their laboratory reports'. ​

Learners will have gained sufficient knowledge of the microbiology of pharmaceutical and healthcare products to enable them to take up responsible positions in QA and QC in Industry.

1. Describe potential microbial contamination problems which would compromise the wholesomeness and safety of Pharmaceutical and Healthcare products.
2. Define the role of the microbiologist in the implementation of appropriate Quality Assurance (QA) and Quality Control (QC) programmes.
3. Identify potential sources of microbial contamination in industry.
4. Assess specific microbiological problems associated with water for pharmaceutical purposes’ and monitor such water.
5. Construct appropriate microbiological QC testing protocols for raw materials, waters, in-process and finished products.
6. Plan and undertake pharmacopoeial microbial limits tests’.
7. Perform total cell counts and viable counts, using a broad range of analytical techniques.

Quality Management for the pharmaceutical, biopharmaceutical, medical device and healthcare industry.

1. Demonstrate a good knowledge of Quality management Systems required for Current Good Manufacturing practice (cGMP), Good Quality Control Laboratory practice, Validation, Regulatory bodies, Environmental, Health & Safety & Occupation regulations.

2. Assess and critically review work practices / facilities / equipment to ascertain compliance with various standards and the risk to safety of employees and processes.

3. Describe the concept of analytical method validation and its critical importance in biopharmaceutical and pharmaceutical QA andQC.

4. Participatein a quality management auditsand make a meaningful contribution to a quality management role.

5. Prepare and implement a safety statement in compliance with E.U. Directives and National legislation.
6. Examine the principles of sustainability in the context of theregulated Biopharmaceutical, Pharmaceutical and Medical Device industries and assist in their implementation.

The main purpose of this module is to introduce the learner to theoretical and practical aspects of recombinant protein production and how this relates to upstream processing in the production of biopharmaceuticals. The module builds on molecular, microbiology and biochemistry modules in year 2 and prepares learners for more advances studies in biopharmaceutical technology and molecular biology in year 4.

1. Discuss homologous and heterologous recombinant protein expression with a focus on (but not limited to) protein expression in E. coli. Distinguish between other expression hosts including yeasts, mammalian cell lines, insect cell lines, transgenic plants and animals.

2. Evaluate and carry out a variety of protein quantification methods and protein analysis techniques such as SDS-PAGE and Western Blotting and bioinformatic analysis

3. Describe protein modification methods at both the DNA codon and amino acid levels.

4. Produce and analyse a recombinant protein.

5. Recognise how the production of a protein in a recombinant cell line relates to upstream processing in biopharmaceutical production.

This module introduces Pharmaceutics, a discipline of pharmacy that corresponds to the science of dosage form design. The module covers all facets of the process of turning a chemical into a safe and effective medication.

1. Distinguish between methods of administrating medicinal products to the body and Identify the factors influencing the route of administration

2. Classify the method of formulation of various pharmaceutical dosage forms including solids, liquids, parenterals, topicals, aerosols, veterinary and sustained-release products

3. Detail the important processing principles used in the manufacture of medicines

4. Explain how the formulation of medicines is controlled with regard to GMP and QC testing

5. Outline emerging trends in Pharmaceutics

This module introduces the learner to the theoretical basis and application of a variety of chromatographic equipment/techniques in chemical, biochemical, pharmaceutical and biopharmaceutical analyses. The analysis of various samples will be carried out in the laboratory to practically illustrate the theory and enable students to develop their analytical laboratory skills.

1. Discuss the underlying theoretical basis for and describe the operating principles of chromatographic techniques. Determine factors such as retention time (tR), adjusted retention time (tR’), Kav, Rf and resolution

2. Discuss the use of and applicability of most chromatographic methods in chemical, biochemical, pharmaceutical and biopharmaceutical analyses.
3. Operate a range of chromatography equipment and optimise separation, using known standards ( internal and external calibrants).Select the correct instrumental technique, most appropriate column type, most suitable standard and experimental conditions to maximise resolution.

4. Have some knowledge of sample pre-treatment to ensure maximum resolutionand maximum column life.
5. Be able to apply these skills to the use of chromatographic methods in project Work/ industrial placement.

This module focuses on microbiological topics specific to (bio)pharmaceutical and medical device manufacturing, with particular emphasis on the quality control of parenterals and other sterile products. The module also addresses environmental monitoring within manufacturing plants and includes a comprehensive introduction to cleanroom technology. Techniques pertinent to the batch release of sterile pharmaceutical products, e.g. endotoxin testing and sterility testing are covered in both theory and practice. The role of antimicrobial preservatives in non‑sterile and sterile products is addressed and pharmacopoeial methods for antimicrobial preservative effectiveness testing are performed. Procedures for the rapid identification of microbial isolates are also included. 'Laboratory practical's will be delivered/rolled out to students with a lecturer-led emphasis on sustainability. Students will be asked to reflect on how they may incorporate sustainability into their practical work when preparing their laboratory reports.

1. Understand the role and evaluate the efficacy of antimicrobial preservatives in pharmaceutical products.
2. Effectively participate in the validation of aseptic processing through Process Simulation Tests.
3. Design and undertake an Environmental Monitoring Programme – surface, air and personnel monitoring.
4. Perform pharmacopoeial sterility tests for validation of sterile products.
5. Understand the principles of cleanroom design and construction.
6. Summarise the personnel disciplines required for operation of cleanrooms and other controlled environments and apply same in practice.
7. Employ rapid methods for the identification of bacteria.
8. Explain the structureof Endotoxins, sourcesandsignificance in parenteral products.

The module is practically-based with an emphasis on interactive discussion and group work. It explores student-centred learning techniques and activation strategies. This module introduces students to the skill of communication with an emphasis on professional communication. It will enable students to develop key communication skills, oral, non-verbal and written to assist them to communicate effectively and professionally in their scientific careers.

1. Plan, design and deliver professional effective oral and written communication ethically, using appropriate medium.
2. Produce professional written documentation following accepted conventions of design, structure and content which is grammatically and technically correct.
3. Reflect on participation with groups and identify ways on which to improve their individual performance.
4. Discriminate between information sources and reference all sources of information using the Harvard referencing style.
5. Create a professional digital presence

6. Develop good documentation practices

Pharmacology is a branch of science dealing with the study of the effects of drugs on biological systems. The focus of this module will be to introduce students to the principles of how drugs act in the body. Students will learn about the concepts of pharmacodynamics (how drugs affect the body) and pharmacokinetics (how the body processes drugs). The module will also explore different drug delivery systems.

1. Explain the processes of drug absorption, distribution, metabolism and excretion in biologicalsystems.

2. Describe the basic mechanisms of drug-receptor interactions.

3. Construct and interpret dose-response curves for agonists and antagonists.

4. Compare and contrast the features of the four main drug targets.

5. Evaluate and compare different drug delivery systems.

The project will combine a research project with a literature review pertaining to the programme of study. The project will be carried out independently by the learner under the supervision of an academic supervisor. This module will enable learners to work effectively and independently in an academic laboratory. Learners will develop their project management, critical thinking, communication, time-management and team-working skills while also enabling them to progress their knowledge in their programme of study.

Learners will also undertake a literature review pertaining to the research topic assigned to them. They will perform the relevant experimental or other research required for thesis collation. The thesis will be assessed via a PowerPoint presentation or poster and viva voce.Learners will be required to reflect on their research work, evaluate the significance of their findings and participate in scientifically reasoned argument.

1. Prepare a literature review having sourcedscientific and/or regulatory literaturethrough the use of electronic or hard-copy journals, books and/or abstracts.

2. Develop a project planwhich includes a feasible aim and corresponding objectives (experimental / investigative methods) that will fulfil that aim. The plan should also incorporate an appropriate timeline.

3. Perform relevant experiments / analyses relating to the planned project objectives.

4. Analyse and interpret data generated during the project in the context of the project aim.

5. Discuss the outcomes of the project and identify areas for improvement in their skills orproject management.

6. Communicate their results in both oral and written form.

This module will provide learners with knowledge of the discovery, development and clinical applications of biopharmaceuticals. Its main focus will be on the design and development of biopharmaceutical drugs which are currently on the market or currently under development. The module will also focus on the technical advances in the area of biopharmaceutical science and give detailed information on key topics such as the influence of genomics and proteonomics on drug discovery. It will also give the learner knowledge with regard to the impact that recombinant DNA technology has had on the design and production of protein and nucleic acid therapeutics and vaccine technology.

1. Develop a thorough understanding of the key steps involved in the development of a biopharmaceutical drug.

2. Compare and contrastthe expression systems used in the production of biopharmaceuticals.

3. Evaluate and assess protein-based therapeutics, their development, production and mode of action.

4. Discuss the impact that genetic engineering has had upon vaccine technology.

5. Describe the clinical applications of aptmers, antisense oligonucleotides and genetherapies.

This module reviews the pharmacokinetics and pharmacodynamics of chemical drug molecules. It describes the pharmacokinetics and pharmacodynamics of biotherapeutics with a particular emphasis on therapeutic antibodies.

Various therapeutic targets are evaluated (i.e. receptors, enzymes, ion channels & transporters), with particular emphasis on receptors and the signalling mechanisms initiated following receptor activation.

The module analyses the short-term regulation of cell function and the mechanisms involved in excitation, contraction, and secretion.

It also addresses the processes of cell replication, proliferation, apoptosis, repair, and regeneration and how they relate to the actions of drug therapies.

1. Critically evaluate the absorption, distribution, metabolism & elimination of chemical drug molecules

2. Evaluate targets for drug action, compare and contrast the structure and activation of different types of receptors as drug targets and evaluate signalling mechanisms that result in physiological effects

3. Analysethe mechanisms involved inthe short-term regulation of cell function

4. Examine the stimulation and proliferation of cells and the pathways involved in programmed cell death, explain how these processes relate to tissue repair, and assess opportunities for intervention with novel therapies.

5. Critically evaluate the pharmacokinetics and pharmacodynamics of therapeutic proteins

6. Apply, process, and condense module materialin the preparation of reports, posters, presentations, and in the completion of continuous assessment quizzes.

This module provides an in-depth knowledge of the structure and key functions of the main regulatory bodies including the Food & Drug Administration (FDA) in the United States, the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines (EDQM) in the European Union (EU) and National Regulatory bodies (i.e. Health Products Regulatory Authority). It also addresses the global harmonisation initiatives and achievements of the International Council for Harmonisation (ICH) and evaluates its role in the regulation of medicinal products.

It examines the current legislation relevant to the development and manufacturing of biotherapeutics. This includes the Federal Food Drug & Cosmetic Act (1938), the Public Health Service Act (1944), and relevant amendments, relevant European Regulations and Directives, and regulatory guidelines. It overviews the Code of Federal Regulations (CFR) and EUDRALEX, the rules and regulations governing medicinal products in the European Union, and evaluates the significance of these volumes in complying with regulatory requirements for the manufacture and marketing of biopharmaceutical products. The various stages in the development of biopharmaceutics are reviewed from a regulatory perspective along with the different types of marketing authorisation applications that may be used, and regulatory inspections carried out at different stages throughout the life-cycle of the product are described.

The module also looks at the challenges involved in regulating biopharmaceuticals compared with chemical drugs. It examines the Critical Quality Attributes (CQA) of biotherapeutics and the Quality by Design (QbD) approach to manufacturing to ensure the safety, quality, and efficacy of these products.

1. Examine the roles of the FDA, EMA, EDQM, & ICH, respectively, in regulating the development and manufacturing of therapeutic antibodies and cell therapies.

2. Evaluate the key legislation governing the regulation of biotherapeutics in the US and the EU and the role of harmonisation initiatives in streamlining global regulatory compliance

3. Apply current GLP, GCP and GMP principles to the development and manufactureof high quality, safe and efficacious therapies, assess critical quality attributes (CQA), and examine the Quality by Design (QbD) approach to biopharmaceutical manufacturing.

4. Assess the key stages and processes involved in regulatory inspections (FDA and European) carried out during the development and production of biopharmaceutical facilities and evaluate different types of inspections.

5. Appraise the key challenges in regulating the development and manufacture of therapeutic proteins and cell therapies compared with chemical drugs

6. Apply knowledge of the United States, European, and National regulatory requirements in the development and manufacturing of biotherapeutics to the analysis presentation of case studies in various formsincludingposters, presentations, and written reports

Statistics is concerned with maintaining and improving the quality of goods and services. Variability is inherent in all processes, whether they be manufacturing processes or service processes. This variability must be controlled to create high quality goods and services and must be reduced to improve quality. This module examines variability in manufacturing processes and introduces the statistical methods,tools and techniques for reducing this variation. Process stability and capability are covered in addition to Experimental Design, Six Sigma and Lean manufacturing.

1. Implement process monitoring fora wide variety of different processes by selecting the most appropriate SPC chart

2. Evaluate the stability of a manufacturing or service process using Statistical Process Control and assess the capability of the processto conform to customer specifications by conducting a PCA study

3. Justify the implementation of a Lean Six Sigma project and execute various techniques as appropriate to each phase

4. Produce a rudimentary Failure Mode andEffects Analysis [FMEA] for a process

5. Examine Cause-and-Effect relationships using Experimental Designand interpret the results of ANOVA.

This module comprehensively covers the theoretical and practical aspects of cell and tissue culture, upstream processing (U.S.P) and downstream processing (D.S.P) and technologies, enabling the learner to effectively participate in these areas. On completion of the module, the learner should be able to proceed to more advanced studies in Bioprocessing.

1. Participate in the design and running of Biopharmaceutical facilitiesincluding details on the facilities lay-outs, utilities, equipment and materials required for biopharmaceuticalprocessing.

2. Develop and maintain cell lines, establishmaster cell stocks (MCS), working cell stocks(WCB) culture collections and inoculumfor biopharmaceutical manufacture.

3. Describe the different stages of upstream processing (USP) and downstream processing (DSP).

4. Perform a range of laboratory and pilot plant practicals relating to cell culture processing.

5. Analyse the technical parameters pertinent to thetechnology & processes required at all stages of bioprocessing.

6. Assess Aseptic Processing and Lyophilisation Technologies used in the biopharmaceutical industry.

7. Current Trends in bioprocessing and biopharmaceutical manufacturing.

This module encompasses a wide range of bioanalytical techniques and assays relevant to the analysis of biopharmaceuticals. The learner will gain practical experience in bioanalytical techniques performed on biopharmaceuticals from the initial upstream processing stages, harvest, downstream processing and the final QC testing of biopharmaceuticals.This module will also provide students with a detailed understanding of a range of specialised investigational techniques and their application areas and associated problems within the biopharmaceutical and related industries.The content delivered in this module is relevant to the skills in the biopharmaceutical sector and students on completion of this module will have a competency in the analysis of biopharmaceuticals.

1. Compare and contrast specialised techniques for potency, concentration and structural analysis of biopharmaceuticals

2. Assimilate the techniques for the analysis of protein puritysuch as SDS-PAGE, Isoelectric focusing, 2D electrophoresis and capillary electrophoresis.

3. Evaluate and assess the applications and associated limitations of the bioanaytical techniques within the spectrum of biopharmaceutical manufacturing such as in raw material, intermediate product and end-product analysis.

4. Perform HPLC, GC-MS, Ion Exchange HPLC, XRF and AFManalysis in the laboratory and demonstrate how bioanalytical techniques both qualitative and quantitative methods, can be applied to the analysis and manipulation of different sample types.

5. Assess the principles, applications and the instrumentation used for advanced aspects of modern analytical techniques such as high performance liquid chromatography (HPLC), gas chromatography, mass spectrometry, atomic force microscope and X-ray fluorescence analysis.

6. Analyse, identify and interpret experimentally-derived data from the analysis of biological/pharmaceutical molecules.

7. Write scientific reports and interpret analytical data from the analysis of biological/pharmaceutical molecules.

This module will provide learners with sufficient knowledge to enable them to adopt responsible positions in the areas of industrial sterilization, cleanroom operations and developmental pharmaceutics (in the context of preservative systems). Learners should be able to evaluate the need for specific sterilization processes in pharmaceutical manufacturing and to effectively contribute to the design and validation of such cycles. The treatment of 'Cleanroom Technology' will enable learners to successfully participate in the design and operational management of cleanrooms and to choose appropriate testing and monitoring protocols for validation of such areas to prove continued compliance with international standards.

1. Summarise the principles of the main industrial sterilization methodologies.

2. Design, validate and monitor industrial sterilization cycles.

3. Present a scheme for the rational development of suitable antimicrobial preservative systems for pharmaceutical and biopharmaceutical products.

4. Discuss the factors governing the action of antimicrobial agents, interaction between such agents and the associated safety and regulatory issues.

5. Analyse the factors pertinent to the commissioning, validation and management of cleanrooms for the pharmaceutical and healthcare sector.

6. Design the Environmental Monitoring programmerequired forcleanroom validation and routine monitoring.

7. Explore constructive arguments for investing in Isolation Technology and select appropriate systems.

8. Advise on the selection and validation of cleanroom clothing.

This module reviews the cells, organs, and microenvironments of the immune system, the mechanisms involved in humoral and cellular immunity, and the structures, functions, and mechanisms of action of different antibody classes. The relationship between the specific structure of IgG and its functions in binding antigen and mediating biological effector functions such as antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) are evaluated.

The development of antibody-based therapeutics, to date, is reviewed. The structures of mouse, chimeric, humanised, and human monoclonal antibodies, respectively, are examined, and the various technologies used in their production are described. Therapeutic antibodies in cancer therapy are analysed and methods to elicit cell death are reviewed including ADCC/CDC, direct targeting of cancer cells to induce apoptosis, targeting the tumour microenvironment, and targeting immune checkpoints.

Chimeric antigen receptor T (CAR-T) cell therapy is investigated and evaluated as an anti-cancer therapy. The structure and evolution of CARs from first to fourth generations are analysed in terms of construct and function. Limitations in autologous CAR-T cell therapy are reviewed. The development of a universal CAR-T (UCAR-T) cell therapy is introduced, and comparisons are made between UCAR-T cell therapy and original CAR-T cell therapy. Other immune cells including natural killer cells (i.e. CAR-NK cell therapy), as an alternative to the use of CAR-T cells, are investigated.

Other antibody-based therapies including immunocytokines, antibody-drug conjugates (ADC), antibody-radionuclide conjugates (ARC), bispecific antibodies, nanobodies, and immunoliposomes are also overviewed.

Strategies used for passive and active immunisation are analysed and traditional and current methods used in the development of vaccines are evaluated with reference to specific examples.

1. Evaluate the relative roles of keyorgans, cells, and molecules of the immune system in eliciting an immune response to pathogens and activating the immune response to vaccination.

2. Compare and contrast the various antibody-associated biological effector mechanisms in eliciting the cell death/removal of pathogens and abnormal self-cells.

3. Assess the strategies used in the development of antibody based-therapeutics, their structures andtargets, and mechanisms involved in eliciting cell-death.

4. Analyse the mechanisms of passive and active immunisation, different approaches to the development of vaccines and their effectivenessin eradicating disease with reference to specific examples

5. Apply, process, and condense technical knowledge of the immune system in the preparation of reports, posters, presentations, and in the completion of continuous assessment quizzes.

This module will provide the learner with an in-depth understanding of current and emerging molecular-based technologies and their biotechnological applications.

1. Critically discuss recent advances in genetic and protein engineering strategies and their biotechnological applications.

2. Evaluate the regulation of gene expression in prokaryotic and eukaryotic cells and the various methodologies employed to analyse gene expression in these systems.

3. Demonstrate a critical understanding of the use of bioinformatics and online molecular biology tools for comparing, analysing and interpreting biological data.

4. Critically assess the use of ‘omics’ technologies in (bio)pharmaceutical research and development.

5. Evaluate current and emerging molecular diagnostic technologies and their underlying principles and applications.

6. Perform advanced molecular biology techniques and present and interpret scientific results.

The research project combines an industrial or academic placement with a literature review pertaining to the programme of study. The placement will be facilitated in an industrial setting (biopharmaceutical / pharmaceutical / diagnostic / MedTech) or research institute under the joint supervision of an academic supervisor and a workplace supervisor. The module will enable learners to work effectively in a highly regulated industrial environment or in an academic or industrial research laboratory. It will develop their project management, critical thinking, communication, time-management and team-working skills while also enabling them to progress their knowledge in Biopharmaceutical Science. Learners will undertake an extensive literature review pertaining to Biopharmaceutical Science. They will perform the relevant experimental or other research required for dissertation collation and give an oral presentation on their work. The dissertation will be assessed via a PowerPoint presentation and viva voce. Learners will be required to reflect on their research work, evaluate the significance of their findings and participate in scientifically reasoned argument. An Academic placement may also be carried out at ATU Galway when facilitation at an Industrial setting is not possible.

1. Source scientific literature and access relevant information through the use of databases, journals, books, abstracts,inter-library loans, the Internet and other electronic media.

2. Selectively abstract, synthesize and collate relevant information.
3. Demonstrate project and time management skills to facilitatedissertation compilation, placement preparation and placement work duty obligations.

4. Reflect on learning activities associated with placementand document reflective synopsesprior to placement culmination.

5. Present reasoned argument and draw appropriate conclusions from their research work.
6. Present a written typeddissertation electronically to moodle.

7. Communicate research results by delivering an oral PowerPoint presentation on their research.

8. Answer technical questions on the research work conducted.