This module pertains to the manufacture of modern biologic products and focuses on various aspects of a typical biopharmaceutical production process such as cell culturing, upstream and downstream processing, biopharmaceutical analysis, formulation, lyophilisation, fill, finish and packaging, The module will also focus on emerging trends in biopharmaceutical manufacturing such as continuous bioprocessing and the move towards the use of single use technology in biopharmaceutical manufacturing.

1. Illustrate and implement an understanding of the key steps involved the delivery and formulation of Biopharmaceuticals

2. Evulateand critical appraise thetechnologies, processesand the technical parameters pertinent to cell culture, upstream and downstream processingwith emphasis on the emergence of technologiessuch as continuous manufacturing and single use technologies for biopharmaceutical manufacturing.

3. Analyse and apply knowledge of the key parameters in biopharmaceuticallyophilization, fill, packaging and labelling.

4. Corroborate an indepth knowledge of the key parameters in biopharmaceutical analysis.

This module provides the student with the design of experiments concepts, tools and techniques for optimising products and processes. The student will learn to build empirical models of a process and assess their validity. The R statistical software or equivalent will be used extensively for data analysis and interpretation.

1. Demonstrate principles of statistical design, hypothesis testing and model diagnostics

2. Plan, conduct and analyse experiments using completely randomised design (CRD) and randomised block design

3. Design,analyse and interpret the results of the factorial, fractional factorial and repeated measures design

4. Analyse and interpret data from experiments involving latin square design, split plots and response surface design

5. Review concepts of statistical power and sample size and theirimplications for design and analysis of experiments

A comprehensive overview of the development and clinical applications of protein, nucleic acid and cell-based therapeutics in the biopharmaceutical sector.

1. Evaluate protein and nucleic acid structure and recognise how structure dictatesfunction and therapeutic effect.

2. Demonstrate key techniques fundamental to recombinant DNA technology and their application in the development and production of protein-based therapeutics.

3. Critically appraise the clinical applications of nucleic acid and whole-cell based therapeutics.

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

5. Lead research on the activities of key players in the biopharmaceutical industry – with focus on the company, products and targeted diseases.

6. Design and perform experiments based on advanced molecular techniques. Present and interpret scientific results.

This module reviews the key regulatory requirements for (bio)pharmaceutical product development, production and marketing. It addresses the role of quality management in determining key factors such as efficacy, purity and safety. It describes the ISO 9000 quality standard requirements of biopharmaceutical manufacturing and addresses the role of ISO 9000 certification in achieving these standards. It describes the difference between quality standards and international regulatory requirements and how quality management is associated with regulatory compliance. It addresses the regulatory requirements of various international regulatory authorities such as the FDA and EMA, National Authorities (i.e..HPRA) and describes the role of the more general ICH guidelines in meeting regulatory requirements.

1. Demonstrate a clear understanding of the role of quality assurance throughout the lifecycle of a biopharmaceutical productand identify key elements monitored by the quality control system in the manufacture of a biopharmaceutical drug.

2. Evaluate the regulatory demands of agencies such as the European Medicines Evaluation Agency (EMA) and Food & Drug Administration (FDA) in terms of the development, production, characterisation and evaluation of biopharmaceutical products

3. EvaluateCritical Quality Attributes (CQA) for biopharmaceutical manufacturing and critically analyse CQAs that demonstrate compliance with regulatiions for different types of biopharmaceuticals.

4. Analyse the role of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH) in regulating biopharmaceuticaldrugs and apply QbD principles to the step-by-step development of a purification process for a biopharmaceutical drug

This module reviews key aspects of the adaptive and innate immune responses. It addresses the response elicited following challenge with antigenic molecules (naturally & artificially) and the key cells and molecules involved. It describes the specific structure of immunoglobulins and their structure function relationships. The development of polyclonal and monoclonal antibodies is discussed along with the manipulation and engineering of antibodies as biotherapeutic agents. The various traditional and modern approaches to the development of vaccines are evaluated. Case studies are used to demonstrate the effectiveness of vaccines in treating infectious disease.

1. Evaluate the respective roles of both the innate and adaptive immune responses in vivo and critically evaluatethe exploitation of the adaptive immune response to produce antibodies.

2. Give a detailed description of antibody structure, analyse the structure/function relationship and discuss key modifications that affect immunogenicity, affinity and potency of antibodies as therapeutic molecules.

3. Develop a strategy and design an experimental approach to produceand characterise a polyclonal antibody.

4. Analyse the development of monoclonal antibodies from murine to humanised molecules, crtically evaluatetheir effectiveness as therapeutic agents and effectiveness of more advancedformatsincluding bispecifics and chimeric antigen receptor (CAR)-T cells

5. Articulate a clear understanding of the mechanisms underlying passive and active vaccination, critically evaluatethe effectiveness of both traditional and modern vaccines, respectively, and discuss thechallenges posed in the development and production of new vaccines.

The module introduces the concepts of operational excellence and examines their applications to the Life Sciences. This module aims to give the student the necessary skills to plan and implement a range of Six Sigma programme activities in a workplace environment.

The module will focus on the tools & techniques required to reduce process variability and thereby achieve Lean Six Sigma in manufacturing and ensure continuous process improvement.

1. Capitalise on the synergy between Lean and Six Sigma and construct an enterprise wide view of their application in the Life Science sector.

2. Develop and lead the implementation of a Lean Six Sigma program activity.

3. Recommend/Implementstatistical tools fromthe Six Sigma Define Measure Analyse Improve Control (DMAIC) toolkit for process improvement.

4. Evaluate and apply appropriatestrategic and tactical design tools (DFSS).

This module aims to provide learners with a broad understanding of Validation in the Biopharmacuetical manufacturing context, including Process, Equipment, Cleaning, Automated System and Test Method Validation.

1. Investigate the regulatory basis for Validation and the relatedrequirements of the (Bio)pharmaceutical sector from regulatory bodies.

2. Communicate the key steps required for anyValidation and fully comprehendthe underpinning principles of specification and verification.

3. Participate and add value as ateam member in industry on multiple types of Validation projects, e.g.Process, Equipment, Cleaning, Automated System orTest Method Validation.

4. Implement the principles of Validation to design and develop Validation documents.

5. Apply risk management and change control to Validation activities and Validated entities, e.g. Process, Equipment, Test Methods.

6. Determine and assess the key validation characteristics of a test method and factors that influence test method variability.

This module will provide the learner with an in-depth knowledge of the regulatory, technical and managerial challenges associated with the design, construction and fitting out of a modern biopharmaceutical manufacturing facility. Site planning, design, commissioning, start-up and validation will be explored and discussed in this module. Following on from facility design and construction, matters such as materials and personnel flow, equipment and the utilities necessary for successful production of biopharmaceuticals will also be covered. Cleanroom classification/design, day-to-day operation, monitoring, maintenance, cleaning, and housekeeping of cleanroom and general facilities will be examined to ensure adherence to regulatory and GMP guidelines.

1. Effectively plan thelayout and functional areas in a biopharmaceutical manufacturingfacility whilst adhering to the regulatoryframework around howfacilities are designed and operated.

2. Indicate athorough understanding ofhow personnel, equipment, materials, product, and waste flow within a facility and indicate a knowledge ofthe access and controls required within such facilities such as security.

3. Elucidate and justify the various cleanroom classifications employed in sterile manufacturing and explainthe equipment, instrumentation, and control systems employed to control and monitor such facilities.

4. Clearly state the functionand purpose of utility and support systems within a biopharmaceutical manufacturing facility.

5. Illustrate an understating of thepreventive maintenance, cleaning, and housekeeping practices that pertain to sustainingbiopharmaceutical manufacturing facilities.

6. Identify and interpret therelevantEU and U.S. standards and guidelinesemployed in a biopharmaceutical manufacturing facility.

This module will provide the learner with a comprehensive knowledge and grounding of machine learning as applied to biopharmaceutical manufacturing processes. Three main areas will be covered: Supervised Learning Unsupervised Learning Reinforcement Learning

Vision in the context of vision systems for the biopharmaceutical industry will form a substantial part of the learning. The module introduces the fundamental concepts of vision systems and applications for a biopharmaceutical manufacturing environment including: Image Acquisition Image Processing Image Analysis

1. Procure, create, and prepare numerical and image data for a machine learning project.

2. Frame a problem in machine learning and optimisation terms.

3. Design a workflow to train a machine learning model

4. Categorise the working principles and applications of a vision system in a modern manufacturing environment.

5. Assess and specify an industrial vision system for a given biopharmaceuticalapplication

This module explores contemporary issues in biopharmaceutical science and examines novel emerging new technologies in this industry. It will evaluate and explore the current trends in Advanced Therapy Medicinal Products (ATMPs) such as cell therapies. It will also focus on emerging trends in biopharmaceutical science such as complex antibodies, genetic vaccines, personalised medicines and 'omics'.

1. Critically evaluate the current trends in Advanced Therapy Medicinal products (ATMPs) with a focuson engineered T lymphocytes.

2. Evaluateand critical appraiseall aspects ofmonoclonal antibodyengineering and analyse the effect that various biochemical and genetic engineering approaches will have onfuture therapeutic antibodies.

3. Compare andcontrasts the various approaches used in the design, delivery and manufacture of genetic vaccines to the body forthe treatment of infections andnon-infectious diseases.

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

Students will undertake an approved research project under the direction of an internal supervisor and, if appropriate, a supervisor from a relevant external organisation. Design of the project should be produced by the learner with the advice of the supervisors and may also be of relevance to an organisation such as an employer.

Learners enrolled are expected to develop the knowledge, know-how and skills, and competencies required to successfully research, develop, scope the project and present and project implementation plan. Learners are expected to either individually or as part of a team develop research, problem analysis, project planning and communication skills at masters level. Projects may be drawn from any discipline within the course or from an area of expertise of the supervisors.

1. Identify and choose a research project topic and plan the delivery of that research project.

2. Select and synthesise information available in scientific literature (and in some cases other literature) in order to establish the need for,
and potential scope and context of, the research project.

3. Develop creative ways of solving new research problems.

4. Collect and analyse data qualitatively and quantitatively, including an assessment of the statistical validity of the research results.

5. Manage resources allocated to completing a research project.

6. Communicate research results in written and oral forms, demonstrating critical analysis, synthesis and organisation of knowledge, and
the construction of a rational and lucid scientific argument.