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Advanced Therapy Medicinal Products (ATMP) Technology and Manufacturing
Postgraduate Diploma in Science
Course Details
Course Code | SG_SATMP_O09 |
---|---|
Level | 9 |
Duration | 2 years |
Credits | 60 |
Method of Delivery | Online |
Campus Locations | Sligo |
Mode of Delivery | Part Time |
Course Overview
Course Details
Year 1
Semester | Module Details | Credits | Mandatory / Elective |
---|---|---|---|
1 |
Introduction to Advanced Therapy Medicinal ProductsThis module is taken by Level 9 students enrolled in either the Postgraduate Certificate in ATMP Cell Manufacturing or the MSc in ATMP technology and Manufacturing / MSc in ATMP Cell Manufacturing Development. It aims to provide students with a background to the concept of ATMPs, including a definition as to what they are from a regulatory standpoint, and a description of the current therapeutic modalities. Furthermore, this module will include an overview of current manufacturing practices for these therapies as well as a brief description of some aspects of quality control. Learning Outcomes 1. Demonstrate detailed knowledge and understanding of the background to ATMPs including current and emerging product types. 2. Describe the manufacturing process required for allogeneic and autologous cell therapies (incl. ex vivo gene therapies) 3. Evaluate current / emerging cell-based therapies for the treatment of inflammation, tissue repair, and cancer and examine associated ethical and societal issues 4. Evaluate current / emerging gene therapy / editing for the treatment of both genetic disorders and other disorders of non-genetic originand examine associated ethical and societal issues 5. Examine the concept of a viral vector for gene therapy delivery and design the associated manufacturing flow |
05 | Mandatory |
1 |
Molecular EngineeringThis module is taken by Level 9 students enrolled in the Advanced Therapy Medicinal Products (ATMPs) course. It aims to provide student with an understanding of how molecular engineering has framed the biopharmaceutical industry's approach to the design of ATMP's both currently on the market and in the clinical trial pipeline. This module will provide students with the necessary skills and tools to understating how ATMP's are engineered to be an effective therapeutic on a molecular and protein level, and the potential of emerging innovations in this field. Learning Outcomes 1. Detail thedesired molecular characteristics of ATMPs and how this impacts the therapeutic potential of the product and how these characteristics are engineered into the process. 2. Evaluate the technology used in the development and manufacture of ATMPs that have achieved regulatory approval and are currently on the market. 3. Review emerging molecular engineering technologies that are currently undergoing research and development in the design of novel ATMPs. 4. Critique the role molecular engineering and design have in the ATMPs currently undergoing clinical trials and discuss the challenges they possess in gaining regulatory approval. 5. Construct molecular engineering approaches that may be utilized in the future generation of ATMPs. |
05 | Mandatory |
1 |
Cell Processing 1The Cell Processing 1 module introduces the basic concepts and issues pertaining to the culture of mammalian cells. 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. Identification of cell viability using visual techniques and assays are discussed. Regulatory requirements for starting materials in cell culture, cell identification and cell purity are also discussed. Learning Outcomes 1. Describe the basics of mammalian cell culture, cell growth and cryopreservation, as it applies to producer cell lines and packaging cell lines 2. Explain the different types and formulations of media / starting materials available and examine their overall importance in optimising the cell culture process and ensuring integrity of the culture 3. Evaluate contamination and biosafety issues and propose in process QC analytical test methods 4. Appraise different cell identification markers for their role in QC analytics 5. Problem solve simulated cell processing quality issues through case studies |
05 | Mandatory |
2 |
Biocontamination Monitoring and Control in ATMP ManufacturingThe Biocontamination Monitoring and Control module introduces the concepts and issues pertaining to biocontamination control with respect to the culturing of mammalian cells and preparation of viral stocks for ATMP manufacture. The module outlines the unique challenges presented when developing ATMPs which due to their short shelf life require the use of rapid methods of detection when screening for contaminants. Learning Outcomes 1. Describe the basics of biocontamination control and best practice 2. Explain the different types of rapid methods available for screening for the presence of bio contaminants including endotoxins viruses and mycoplasma in raw materials, cell and viral stocks. 3. Develop a biocontamination control strategy with respect to raw material release and allogeneic donor recruitment. 4. Problem-solve simulated quality issues through case studies of biocontamination incidents. 5. Understand the regulatory expectations with respect to biocontamination control when manufacturing ATMPs. |
05 | Mandatory |
2 |
Cell processing 2 with QC Analytical TechniquesThe Cell Processing 2 module aims to provide students with the essential knowledge regarding cell processing and cell alteration within the ATMP space. It introduces cell based therapies, such as mesenchymal or stromal stem cells, CAR-T cells, CAR-NK cells etc. The module will cover the life cycle of the cell from donor recruitment, cell selection, segregation, manipulation, formulation, QC release and delivery, introducing and current and future technologies and techniques. The module will also examine regulatory requirements and evaluate ethical and societal impact of these technologies. Learning Outcomes 1. Describe the production cycle of a therapeutic cell product from donor to patient, being cognisant of the phenotypic and functional characteristics of cell therapies, patient safety,GMP and other regulatory conditions. 2. Describe and evaluate different transfection techniques for cell modification 3. Appraise new technologies for cell sorting, formulation etc and compare different methodologies for different cell products 4. Formulate judgement on appropriate QC tests and analyse simulated QC data 5. Construct proposals for an application of cell therapies to meet an unmet clinical need and defend safety, societal and ethical impacts of these technologies. |
05 | Mandatory |
2 |
EU Qualified Person (QP) Certification of ATMPsThis module aims to provide students with an understanding of Qualified Person (QP) certification responsibilities and considerations for Advanced Therapy Medicinal Products (ATMP) and how they differ to traditional pharmaceuticals. In addition, the students will get an overview of the EU and US regulations that apply to ATMPs with a focus on QP aspects. Learning Outcomes 1. Describe the responsibilities of the QP when certifying ATMPs 2. Differentiate between EU and US regulations and guidances in relation to manufacturing and testing of ATMPs 3. Evaluate and describe vendor qualification requirements for ATMPs 4. For a given ATMP, determine the importation, distribution and transportation requirements for ATMPs 5. Assess ATMP manufacturing and testing challenges and construct solutions |
05 | Mandatory |
Year 2
Semester | Module Details | Credits | Mandatory / Elective |
---|---|---|---|
1 |
Nucleic Acid TherapiesThis module aims to provide students with the background in nucleic acid biology, current implementation and the future of their role in healthcare. The course will provide students with the knowledge and understanding of the emerging role Nucleic Acid Therapies (NATs) in both current and future therapies. Learning Outcomes 1. Describe nucleic acid biology in detail 2. Discuss and evaluate the potential clinical significance of nucleic acid therapies (NATs), critiquing current research. 3. Differentiate between different NATs for different applications and describe / predict their modes of action in vivo . 4. Evaluate current mRNA vaccine technology and appraise advances in this technology. 5. Construct proposals for an application of NATs to meet an unmet clinical need and defend safety, societal and ethical impacts of these technologies |
05 | Mandatory |
1 |
Operations Excellence and Risk ManagementOperations Excellence and Risk Management details the philosophy, continuous improvement methods, systems and tools used in management of products, processes, services and supply chains to achieve excellence. This module aims to provide students with an introduction to current and future knowledge of strategic operations including Industry 4.0 and Smart Operations engineering and management in the context of a GMP environment. The module also aims to provide students with an understanding of various structured approaches to Risk Assessment and Management in the ATMP industry. Learning Outcomes 1. Describe the strategic importance of operations and how it relates to other business functions; evaluate performance objectives, product life cycle and the volume and variety effect and how these impact strategic decision making. 2. Demonstrate an awareness of the philosophy of operations excellence and Industry 4.0; analyse continuous improvement tools and datasets such as JIT, Lean, six sigma, statistical process control, error proofing and evaluate appropriate methodologies. 3. Apply Lean Six Sigma tools such as Value Stream Metrics, SMED, 5S,Visual Management, TPM, Kaizen Events, Creating Continuous Flow, Process Capability etc. 4. Discuss the regulatory requirements for risk assessment and management and interpret what is required to comply with these requirements. 5. Demonstrate use of problem solving (e.g. fishbone, 5 why etc) and risk management tools such as FMEA, HACCP etc. in a simulated scenario |
05 | Mandatory |
1 |
ATMP Quality Systems and Regulatory AffairsThis module is taken by Level 9 students enrolled on the MSc. in ATMP Manufacturing. It aims to provide students with the background of Advanced Therapy Medicinal Products (ATMP) and how they differ to traditional biopharmaceuticals. In addition, the students will get an overview of the EU and US regulations that apply to ATMPs. Learning Outcomes 1. Discuss the nature and production of ATMP products 2. Describe ATMP manufacturing challenges, current and developing technologies, and quality control / quality affairs 3. Evaluate the global regulatory framework for biotechnology derived products 4. Differentiate the applications of EU & US regulations for ATMP marketing authorisations 5. Critically analyse EudraLex Volume 4 part IV and Annex I |
05 | Mandatory |
2 |
Viral and Non Viral Vector Production SystemsThis module is to be taken by Level 9 students enrolled on the Certificate in ATMP Vector Manufacturing / MSC in ATMP Technology and Manufacturing or the MSc in ATMP Manufacturing Development (60 credit thesis). It aims to provide students with the background in vector production, both viral and non-viral means. The biology, current and future vector systems will be covered to give students and overall understanding of the uses and importance of vector use for clinical outcomes. The course also focusses on the manufacturing and production process of vectors to ensure students have a complete understanding of the methods and reasons behind the challenges and steps required to supply demand. Learning Outcomes 1. Describe vector biology of common vector systems and differentiate between different vector systems for different applications. 2. Describe and evaluate the manufacturing, purification and formulation processes for viral vectors. 3. Examine existing and emerging non viral vector systems and describe manufacturing methods associated with these. 4. Evaluate manufacturing optimisation processes and critique new and emerging technologies 5. Propose relevant QC analytical test methods for different stages of vector production |
05 | Mandatory |
2 |
Delivery Systems and Tissue Engineering ProductsThis module is an introduction to the interdisciplinary field of tissue engineering and regenerative medicine using delivery systems. Essentially, new and functional living tissue can be fabricated by delivering cells, scaffolds, DNA and/or proteins at surgery. This course will introduce advances in the fields of material science, regenerative medicine and their relationship towards developing novel "cell, gene and tissue engineered" therapies. Learning Outcomes 1. Evaluate established and emerging natural and synthetic biomaterials for their uses in cell / gene delivery and as tissue engineering scaffolds 2. Compare efficacy of new and emerging polymer systems for gene and cell delivery, such as nanoparticles, lipid based systems, glycopolymers, smart polymers etc 3. Describe and analyse tissue engineered scaffold fabrication methods, and evaluate the role of bioreactors in cell / scaffold development 4. Demonstrate an appreciation of preclinical and clinical testing requirement and suggest suitable in vitro and in vivo test methods 5. Formulate hypotheses to treat existing clinical problems that would benefit from targeted delivery / tissue engineering approach and evaluate associated sustainability andethical concerns |
05 | Mandatory |
2 |
Research Methods BiopharmaThe purpose of this module is to complete a research proposal which may subsequently form part of the MSc thesis. Students will have the opportunity to formulate a research topic, develop a research schedule and select appropriate methodologies for a research project. The learner will study different research methods, ethical considerations, learn how to critically analyse scientific documents, disseminate research in terms of reports, and communicate effectively. Learning Outcomes 1. Produce a research proposal document. 2. Undertake a focused literature search and generate a literature review on a research topic. 3. Select and apply an appropriate research methodology while adhering to ethical considerations. 4. Communicate effectively their research outcomes. |
05 | Mandatory |
Recommended Study Hours per week
Examination and Assessment
On-Campus Attendance Requirement
Progression
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Entry Requirements
Applicants whose first language is not English should provide evidence of English language proficiency. For further information on English language requirements click here