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.

Manufacturing processes for biopharmaceuticals must be designed to produce products that have consistent quality attributes. This manufacturing process involves fermentation technologies, product recovery and the removal of impurities and contaminants that include endotoxins, viruses, cell membranes, nucleic acids, proteins, culture media components, process chemicals, and ligands leached from chromatography media, as well as product modifications, aggregates, and inactive forms. This module is designed to provide the student with a comprehensive understanding of the manufacturing process involved in the production of biopharmaceuticals.

1. Illustrate and implement an understanding of the key steps involved in the development of a biopharmaceutical drug.

2. Evulateand critical appraise thetechnologies,processesand the technical parameters pertinent to the upstream and downdstream procceses in biopharmaceutical manufacturing.

3. Analyse and apply knowledge of the key parameters in biopharmaceutical product formulation, lyophilization, 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 experiment concepts, tools and techniques for optimising products and processes. The student will learn to build empirical models of a process and assess its validity. The R statistical software or equivalent will be used extensively for data analysis and interpretation.

1. Conduct two and three level fractional factorial experiments and analyse the resulting data.

2. Plan, conduct and analyse experiments using Response Surface Methodology (RSM).
3. Analyse multiple response experiments and interpret the results.

4. Analyse and interpret data from experiments involving random effects models.

5. Use the expected means square rules to develop the appropriate statistical model.

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

The research project is the culmination of the Biopharmaceutical Higher Diploma. The project should take the form of a proposal for design and development of a biopharmaceutical product to prevent treat or diagnose a specific medical condition. The student will undertake a literature review to source information on the target condition and current gold-standard therapies. Based on this information and the student's knowledge gained through the programme, the student should propose an alternative biopharmaceutial product, for prevention, treatment or diagnosis of said medical condition. Thereafter, students should include a detailed overview of the design, function, clinical trials, manufacturing, validation and quality control testing prior to release of their proposed product. The students will apply their knowledge of quality standards and regulations pertaining to the manufacturing of biopharmaceutical products throughout this work.

1. Lead the development of a proposal for the design and manufacture of a biopharmaceutical product.

2. Critically evaluate and reviewliterature (and other relevant, reliable sources) using appropriate keywords and databases.

3. Synthesize and collate relevant information from the programme modules to apply their knowledge to a current medical concern and the proposed design, manufacture, release and control of a biopharmaceutical.

4. Communicate results of the reviewin written and oral forms, demonstrating critical analysis, synthesis and organisation of knowledge.

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 address the key principles at the forefront of the fields of immunotechnology, molecular diagnostics and rapid microbiological testing. A comprehensive overview of the current and emerging technologies used in the analyses of pharmaceutical and biological samples will be covered.

1. Develop a systematic understanding of knowledge at the forefront of the field of immuno- and molecular diagnostics and rapid microbiologicaltesting.

2. Critically comment on the technical range of standard and specialised research tools and techniques of enquiry including immunoassays, polymerase chain reaction (PCR) and next generation sequencing (NGS).

3. Articulate the key considerations of assay validation methods and sensitivity and specificity determinations.

4. Develop new skills to a high level, including novel and emerging techniques such as antibody purification for use in the development of immunodiagnostic assays.