Advanced Therapy Medicinal Products (ATMP) Cell Manufacturing

Master of Science

Course Details

Course Code	SG_SATMR_M09
Level	9
Duration	3 years
Credits	90
Method of Delivery	Online
Campus Locations	Sligo
Mode of Delivery	Part Time

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Advanced Therapy Medicinal Products (ATMP) Cell 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 programme is designed to provide students with a comprehensive grounding in critical aspects of ATMP cell therapy and quality control / quality affairs. The course will allow participants to develop the competencies and skills required to be employed in technical, quality, research and manufacturing roles within the growing ATMP industry. This MSc has a specific research focus aimed to develop and enhance emerging technologies in the ATMP cell manufacturing space and will allow students to synthesise novel solutions that add value to the workplace and the knowledge base in ATMP cell manufacturing.

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	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

Year 2

Semester	Module Details	Credits	Mandatory / Elective
Year	ATMP Thesis (60 Credit) This 60 credit research project will allow the candidate to investigate an area relevant to Advanced Therapy Medicinal Products (ATMPs), from their place of work in industry and write a 25,000-30,000 thesis based on their findings. The proposed industry-relevant research will be agreed by the Programme Coordinator prior to commencement. The project may take the form of a work-based or laboratory-based project, to address challenges faced by the ATMP sector; creating new problem diagnoses, designs, or system insights that contribute to professional practice. Learners will examine and define the research question, critically analyse published literature, select and execute appropriate methodologies, analyse and interpret data, critically evaluate findings and draw justifiable conclusions, demonstrating self-direction and originality of thought. The learner will be assigned an academic supervisor who will advise on the direction of the research based on the results presented to them. Throughout the period of research, the candidate is encouraged to network with other researchers in academia and industry and to disseminate their research findings in oral and written format to both academic and professional audiences. The work will cumulate with the submission of a research thesis and a viva voce. Learning Outcomes 1. Manage an independent research project with guidance from the academic supervision. 2. Source and critically evaluate published academic literatureto draw inferences andplace research project in context. 3. Develop and justify a coherent research proposal with an acceptable research question or hypothesis. 4. Conduct the project by selecting and applying appropriate research methodology and analysing the data according to accepted models of analysis. 5. Sustain from the evidence obtained, a reasoned argument and draw consistent and coherent conclusions from the research evidence. 6. Write a research thesis on an area relevant to ATMPs according to specified guidelines which meets postgraduate standards of technical expertise 7. Develop professional practice skills including time-management, scientific technical writing and effective oral communication skills.	60	Mandatory

Recommended Study Hours per week

4 hours independent study per week are recommended per module.

Examination and Assessment

The assessment approach for this module will be 100% continuous assessment with a range of assessment methods employed including some of the following: shortform assessment exams incl. MCQs, project assignments, essays, enquiry based learning, oral presentations, viva’s etc.

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

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: €8496

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.