Advanced Therapy Medicinal Products (ATMP) Vector Manufacturing

Master of Science

Course Details

Course Code	SG_SATMQ_M09
Level	9
Duration	2 years
Credits	90
Method of Delivery	Online
Campus Locations	Sligo
Mode of Delivery	Part Time

How to Apply

Advanced Therapy Medicinal Products (ATMP) Vector Manufacturing

How to Apply

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 course is designed to give students a grounding in critical aspects of ATMP vector manufacturing and quality control / quality affairs. By undertaking this course, students will gain an understanding of the facts, concepts, principles, theories and methods associated with vector manufacturing in the context of the ATMP industry. Throughout the course the student will get a detailed knowledge, experience and understanding of the theories, paradigms, defining concepts and underlying principles of the ATMP vector product life cycle, and evaluate new and emerging technologies. This MSc has a specific research focus aimed to develop and enhance emerging technologies in the ATMP vector manufacturing space.

Course Details

Year 1

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

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

Students should expect to allocate 5 hours on average per week per 5-credit module.

Examination and Assessment

100% continuous assessment, with a variety of assessment methods.

On-Campus Attendance Requirement

No on-campus attendance required.

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.