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

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Advanced Therapy Medicinal Products (ATMP) Technology and Manufacturing

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Course Overview

This programme is run in conjunction with NIBRT (National Institute for Biopharmaceutical Research and Training), with many of the lecturers and guest lecturers from NIBRT. At the start of 2022, IDA Ireland confirmed a €21 million capital investment in NIBRT to enable the construction, equipping and staffing of a 1,800m2 extension which will focus on research and training in the manufacture of advanced therapies. Construction of this NIBRT Advanced Therapies building extension is underway and is scheduled to open in 2023.

NIBRT established the Cell and Gene Therapy (CGT) Forum in 2018, which comprises stakeholders from across industry, academic researchers and government agencies, with the aim of making Ireland a global leader for the development, manufacture, supply and adoption of advanced therapies and novel vaccines (NIBRT Annual Report, 2022).

The programmes seek to enhance graduate employability by building in elements of case studies, group work, simulated problem solving, examples in context, and use of guest lecturers where feasible and appropriate. Modules such as Biocontamination, Cell Processing and Research methods enhance employability, as they are very transferable across sectors and do not limit students to specific roles. Key learning opportunities for students will be to apply their knowledge gained through the course to real workplace problems in real time, thus enhancing their skills and employability.

This new Pg Cert in ATMP Technology and Manufacturing aims to provide scientists and engineers with a comprehensive grounding in critical aspects of ATMP cell therapy and vector manufacturing and quality control / quality affairs. The programme will allow participants to develop the competencies and key skills to be employed in technical, quality and manufacturing roles within the growing ATMP industry. By participating in the programme, students will develop an understanding of the facts, concepts, principles, theories and methods associated with cell therapy and vector manufacturing in the context of the ATMP industry.

Course Details

Year 1

Semester	Module Details	Credits	Mandatory / Elective
1	Introduction to Advanced Therapy Medicinal Products This 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 Engineering This 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 1 The 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 Manufacturing The 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 Techniques The 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 ATMPs This 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 Therapies This 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 Management Operations 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 Affairs This 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 Systems This 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 Products This 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 Biopharma The 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

Students will attend 3 online lectures per week and make additional time for independent learning. Usually this is around 5 hours per module.

Examination and Assessment

This programme is assessed through a combined approach of continuous assessment including project work, presentations and case studies.

On-Campus Attendance Requirement

No on-campus attendance required.
Note: Check programme Examination and Assessment requirements, as they may involve examinations to be taken on campus.

Progression

The Postgraduate Certificate in ATMP Technology and Manufacturing can be taken as a standalone but is also embedded in the Master of Science in ATMP Technology and Manufacturing. The programme will be delivered in conjunction with NIBRT. Research Postgraduate opportunities at ATU are offered at Level 10 (PhD).

Download a prospectus

Postgraduate Prospectus Online, Flexible & Professional Development Prospectus

Entry Requirements

The programme is open to students who have completed a minimum of a 2.2 Honours Level 8 degree in a Science or Engineering subject related to the life sciences. Other candidates with alternative honours degrees and experience in the ATMP industry may apply for consideration (typically 5 years duration in a GMP environment). The entry requirements will encompass recognition of prior accredited learning in other third level institutions, in accordance with ATU procedures.

RPL is a process that may allow you to gain admission to a programme or to receive exemptions / credit from some parts of a programme based on demonstrated learning that you may have achieved through another programme of study or through your work and career. Further information is available through our dedicated RPL portal www.atu.ie/rpl or by contacting our admissions team at admissions.sligo@atu.ie

English requirement
Applicants whose first language is not English should provide evidence of English language proficiency. For further information on English language requirements click here

Fees

Total Fees EU: €9996

Further information on fees

Careers

The programme was conceived in response to consultation with NIBRT on the expansion of the ATMP sector in Ireland, and the need for structured educational offerings aimed to upskill / cross skill staff in existing biopharmaceutical science jobs. The course content was developed closely with NIBRT and in response to industry input and feedback.

This programme is aimed at manufacturing, quality, engineering and regulatory personnel who are looking to increase their understanding and application of ATMP technologies. It will provide a postgraduate qualification in the area of ATMP manufacturing that will form both an introduction for new or proposed entrants to the area and additional skills and knowledge to those working in the area. This course will give them the opportunity to move upwards to leadership roles.