| Program start date | Application deadline |
| 2024-09-01 | - |
Program Overview
Course Overview
Winner of the Best New Postgraduate Course 2020 award in the GradIreland Higher Education Awards. To read more about this accolade, click here.
Why choose this programme?
Professor Frank Barry, Scientific Director of the Regenerative Medicine Institute
Cell and gene therapy was identified as the most exciting therapeutic innovation by 79% of the 151 international biopharmaceutical manufacturers surveyed by the NIBRT, the Irish National Institute for Bioprocessing Research and Training (Trends in Manufacturing Report). The same organizations have difficulty filling available positions, specifically citing the need to hire bioprocess engineers and automation engineers.
The primary objectives of the MSc in Cellular Manufacturing & Therapy at the University of Galway is to A) provide formal training in cellular bioprocessing for clinical application and B) cultivating a rigorous scientific underpinning for the development of a cellular therapy. The course curriculum balances the scientific aspects of cellular therapy (in 3 modules), bioprocessing and manufacturing regulation (in 2 modules) and offers optional modules in cancer biology, business, clinical trials and bio-ethics. A student’s practical skills are developed beyond the classroom laboratory activities with supplemental activities such as workshops in sterile gowning and a 4-month work or laboratory placement, thereby gaining research or enterprise-centric skills. When launching, this MSc programme was the first of its kind worldwide.
Unique position
The MSc in Cellular Manufacturing and Therapy is the one and only course in Ireland offering the following opportunities in support of a career in cellular therapy:
New skills
Through the course activities, students will have the opportunity to develop both technical and transferrable skills. Technical skills will be acquired through practical activities and module assessments, including aseptic technique in mammalian cell culture; cryopreserving and thawing cryopreserved cells; plating and expanding adherent and mammalian cells; quantifying cell number, viability, density; pipetting large and small volumes; sterile gowning; data collection, presentation and analysis and technical writing. Transferable skills will be developed through course workshops and group activities, including the ability to meet deadlines; adaptability and flexibility, analysis and decision making, critical thinking and evaluation of the literature, research/scientific integrity, team leadership, networking, organization, public speaking, time management and written communication.
What makes this course unique ...
Modules in the biology underpinning the therapeutic application of mesenchymal stromal cells, immunotherapy and induced pluripotent stem cells, three types of cellular therapy currently in translation for clinical application.
Instruction by a multidisciplinary team of experts, the first to translate cellular therapies from the bench to clinical application in Ireland.
Four-month placement where student are embedded in a host environment corresponding to their carer of choice.
Allied University of Galway courses
MSc in Regenerative Medicine. Click here to learn more.
MSc in Microscopy and Imaging. Click here to learn more
Scholarships available
Find out about our Postgraduate Scholarships here.
Applications are made online via the University of Galway Postgraduate Applications System.
Who Teaches this Course
Collaborative delivery of course content
The MSc in Cellular Manufacturing & Therapy is delivered by experts in the field of cellular manufacturing and pre-clinical research supporting the development of new therapies; those directly responsible for pioneering cellular manufacturing and therapy in Ireland. As an example, the Centre for Cell Manufacturing Ireland (CCMI) team (Ireland’s first centre for cell manufacturing) are active instructors in the Cellular Manufacturing 1 and 2 modules where the learning activities are centred around bioprocessing and its regulatory and quality oversight. Professors O’Brien, Barry and Griffin, pioneering coordinators of the first cellular therapy clinical trials in Ireland, deliver an in-depth lecture series in the Mesenchymal Stem Cell Therapy module where they describe the pre-clinical and clinical aspects of developing cellular therapies.
Developing, producing and applying a cellular therapy clinically is a multidisciplinary challenge. We rely on collaboration with experts in each of these fields to contribute their knowledge and insight within this programme. Examples of these collaborative activities in the past include:
Industrial collaboration
Academic Collaboration
Collaborations with Clinicians and Patients
Mr Andrew Finnerty Dip., MBA View Profile
Program Outline
Course Outline
Programme curriculum:
The Cellular Manufacturing & Therapy suite of programmes are available in a 1-year full time format that suit individuals completing their BSc or transitioning between careers. Courses are also available in a two-year part time format or in “microcredits” making it available to employed individuals hoping to upskill while continuing employment. The modules are available in a variety of formats giving accessibility to a wide range of students with different learning styles, including a lecture-based format, a flipped classroom format, in blended learning and fully online.
The Cellular Manufacturing & Therapy suite of courses are on offer as an MSc programme (90 ECTS), as a post-graduate diploma programme (60 ECTS) or as a post-graduate certificate programme (30 ECTS). Both the MSc and post-graduate diploma are available in a one-year full time capacity or 2-year part time capacity. To see the proposed core and optional modules available in each programme starting in the next academic yaer, please click here
Curriculum information
Curriculum information relates to the current academic year (in most cases). Course and module offerings and details may be subject to change.
Curriculum Information
Curriculum information relates to the current academic year (in most cases).
Course and module offerings and details may be subject to change.
Glossary of Terms
Credits
You must earn a defined number of credits (aka ECTS) to complete each year of your course. You do this by taking all of its required modules as well as the correct number of optional modules to obtain that year's total number of credits.
Module
An examinable portion of a subject or course, for which you attend lectures and/or tutorials and carry out assignments. E.g. Algebra and Calculus could be modules within the subject Mathematics. Each module has a unique module code eg. MA140.
Optional
A module you may choose to study.
Required
A module that you must study if you choose this course (or subject).
Semester
Most courses have 2 semesters (aka terms) per year.
Year 1 (90 Credits)
Required
MD1521:
Cellular Manufacturing I
MD1521: Cellular Manufacturing I
Semester 1 | Credits: 10
The production of cellular therapeutics, a defining technology of the next century, presents a unique, complex challenge combining expertise in biology, engineering, regulatory oversight and quality assurance. This course aims to instil a fundamental, working knowledge of tissue procurement, cellular expansion and biobanking and advances in bioreactor technology. The overall scope of the module is broad, ranging from the fundamental biology of mammalian cell culture to engineering advancements leading to automated biomanufacturing of clinical therapies with constant emphasis on the production of advanced medicinal products. The principals gained from participating in this course provide an overall reference for the biomanufacturing process underpinning the production of cellular therapeutics. This module is a pre-requisite for Cellular Biomanufacturing II.
(Language of instruction: English)
Learning Outcomes
- Combine a fundamental knowledge of therapeutic tissue procurement and cellular isolation, expansion and cryopreservation with advances in the literature to propose a novel methodology for manufacturing a cellular therapy.
- Recognize and evaluate advancements in bioreactor technology, strategic scale-up technologies and process design to improve biomanufacturing processes.
- Identify advances in technique, reagents and procedures, applying them to good manufacturing practice policies in the production of a cellular therapy.
- Master the calculations associated with cellular expansion profile, anticipated yield, etc.
Assessments
This module's usual assessment procedures, outlined below, may be affected by COVID-19 countermeasures. Current students should check Blackboard for up-to-date assessment information.
Module Director
Research Profile
| EmailLecturers / Tutors
The above information outlines module MD1521: "Cellular Manufacturing I" and is valid from 2020 onwards.
Note: Module offerings and details may be subject to change.
Required
MD1522:
Cellular Immunotherapy
MD1522: Cellular Immunotherapy
Semester 1 | Credits: 10
Adoptive cell therapy (ACT) offers the chance to utilize a patient’s own immune cells to effectively recognize and eliminate cancer cells. The most effective modality of ACT employs genetically modified chimeric antigen receptor expressing T cells (CAR T) to target surface proteins overexpressed on cancer cells. This strategy is unique from other forms of ACT, as target recognition is not MHC restricted. CAR T cells have demonstrated significant clinical potency in the treatment of certain leukemias, and trials targeting solid tumour indications are now commencing. The module is designed to deliver the current theory, practices and future perspectives in regard to collection, expansion, modification and clinical application of cancer immune cell therapy, specifically, but not limited to T cells. The following topics will be presented: history of CAR T development, strategies for effective gene delivery, cell production platforms and processes, initial clinical results associated toxicities and clinical management, challenges associated with targeting solid tumour antigens, novel CAR designs and technologies. The module will include also introduction to haematopoietic stem cell transplantation.
(Language of instruction: English)
Learning Outcomes
- Demonstrate in depth knowledge of basic immunology and types and sources of immune cell
- Present practical knowledge of heamatopoietic stem cell transplantation
- Demonstrate understanding of immune cell collection and expansion methods
- Demonstrate knowledge of methods of cell isolation, characterization and banking
- Evaluation of safety and efficacy specific to immune cellular products
- Discuss and practically implement the use of CAR T cell technology in the design of cellular immune therapeutics
- Critical review of current and future therapeutics applications of CAR technology in malignant disorders
Assessments
This module's usual assessment procedures, outlined below, may be affected by COVID-19 countermeasures. Current students should check Blackboard for up-to-date assessment information.
Module Director
Research Profile
| EmailLecturers / Tutors
Reading List
- "Developments in T Cell Based Cancer Immunotherapies" by Paolo A. Ascierto
The above information outlines module MD1522: "Cellular Immunotherapy" and is valid from 2017 onwards.
Note: Module offerings and details may be subject to change.
Required
MD1523:
Cellular Manufacturing and Therapy Dissertation
MD1523: Cellular Manufacturing and Therapy Dissertation
15 months long | Credits: 30
The aim of this module is for students to A) gain relevant working experience within the field of cellular manufacturing and therapy or B) evaluate and critically assess the state of the art of specialized areas of cellular biomanufacturing and therapy. If the student is entering into a ~4 month work experience programme, this placement may be in an academic or industrial setting. Depending on the placement host, the student may be located in Galway or may be required to transfer domestically or internationally as required. Alternatively, students have the option to create a literature-based review of an area relevant to cellular manufacturing and therapy where they will be instructed in technical writing, the peer review process as well as oral and written presentation skills.
(Language of instruction: English)
Learning Outcomes
- Present a comprehensive review of 1) a research organization or company advancing the state of the art in cellular manufacturing and therapy or 2) assessing the published state of the art in a specialized area of cellular biomanufacturing and therapy.
- Discuss, present and defend their 1) contribution to an organization during a 4 month work placement or 2) literature review and critical analysis.
- Demonstrate competence and professionalism in oral and written communications.
Assessments
This module's usual assessment procedures, outlined below, may be affected by COVID-19 countermeasures. Current students should check Blackboard for up-to-date assessment information.
Module Director
Research Profile
| EmailLecturers / Tutors
The above information outlines module MD1523: "Cellular Manufacturing and Therapy Dissertation" and is valid from 2019 onwards.
Note: Module offerings and details may be subject to change.
Required
MD1524:
Cellular Manufacturing II
MD1524: Cellular Manufacturing II
Semester 2 | Credits: 10
In Cellular Manufacturing II students will be learning about the complexity of translation of practical knowledge acquired in module I into patient deliverable therapy. The module will cover the complex regulatory environment and national and international requirements. The management of cellular manufacturing facility, including operation management, staffing, planning, scheduling, budgeting, quality and role of master file will be included. This module will also deliver on key aspects of clinical trials design, trial approval and Good Clinical Practice requirements. The modules I and II should prepare a student to take on relevant roles in cell manufacturing organisations.
(Language of instruction: English)
Learning Outcomes
- Discuss the regulations and guidelines for cell isolation, freezing, thawing and administration of cellular products
- Recognise key aspects of National, European and International regulatory affairs.
- Describe key aspects of planning, costing of goods, operations management, health systems and policy (reimbursement)
- Design of GCP-compliant preclinical studies
- Design of bioprocesses for autologous/allogeneic therapies
- Perform risk-based assessment of GMP-compliant processes for the production of cell-based therapies.
- Discuss compliance and accreditation procedure for quality assurance standards (JACIE and others).
Assessments
This module's usual assessment procedures, outlined below, may be affected by COVID-19 countermeasures. Current students should check Blackboard for up-to-date assessment information.
Module Director
Research Profile
| EmailLecturers / Tutors
Reading List
-
"Cell Therapy: cGMP Facilities and Manufacturing" by Adrian Gee
Publisher: SPRINGER
- "Guide to Cell Therapy GxP: Quality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical Environments" by J. Vives
- "Advances In Pharmaceutical Cell Therapy: Principles Of Cell-Based Biopharmaceuticals" by R. Huss,
-
"Cell Therapy : cGMP Facilities and Manufacturing" by Adrian Gee
Publisher: Springer
- "WHO good manufacturing practices for sterile pharmaceutical products" by World Health Organisation, Annex 6
The above information outlines module MD1524: "Cellular Manufacturing II" and is valid from 2017 onwards.
Note: Module offerings and details may be subject to change.
Required
MD1526:
Mesenchymal Stromal Cell Therapy
MD1526: Mesenchymal Stromal Cell Therapy
Semester 2 | Credits: 10
The successful application of mesenchymal stromal cells (MSCs) as an advanced medicinal product is reliant upon selecting the appropriate cell source and its therapeutic mechanism of action complimenting the intended application. This course aims to instil a fundamental, working knowledge of cellular procurement, the ongoing application of MSCs in clinical trials and the next generation of cellular therapeutics. The overall scope of the module is broad, ranging from the fundamental biology of mesenchymal stromal cells and their therapeutic applications to evaluating recent advancements in MSC preclinical trials to develop the next therapy. Included are hands on, laboratory-based skills including cell culture. The principals gained from participating in this course provide an overall reference for the evaluation of current literature to identify an appropriate cell source, to comprehend its mechanism of action and create a path to examine its pre-clinical efficacy in support of a regulatory submission.
(Language of instruction: English)
Learning Outcomes
- Compare and contrast the qualities of progenitor cells from various tissue sources in relation to their intended application.
- Demonstrate practical competence in mesenchymal stromal culture expansion and cryopreservation.
- Evaluation of the current literature regarding the safety and efficacy of mesenchymal stromal cells in pre-clinical and clinical applications.
Assessments
This module's usual assessment procedures, outlined below, may be affected by COVID-19 countermeasures. Current students should check Blackboard for up-to-date assessment information.
Module Director
Research Profile
| EmailLecturers / Tutors
The above information outlines module MD1526: "Mesenchymal Stromal Cell Therapy" and is valid from 2020 onwards.
Note: Module offerings and details may be subject to change.
Required
MD1529:
Induced Pluripotent Stem Cell Therapy
MD1529: Induced Pluripotent Stem Cell Therapy
Semester 2 | Credits: 10
The Induced Pluripotent Stem Cell module is aimed to provide theoretical and practical background of the fast developing field of iPS cell research and at giving participants practical experience in derivation of induced pluripotent stem cell lines, maintenance in the culture, cell characterisation, expansion of iPS cells and differentiation into neuronal, cardiac and other tissues. The module will provide current knowledge of key scientific discoveries leading to development of reprogramming protocols and iPS technology. During the lectures, the ethics of iPS research and therapies, role of iPS in disease modelling, regeneration and therapy of hereditary (neurodegenerative and others) and acquired (heart failure, diabetes, cancer) disorders will also be discussed.
(Language of instruction: English)
Learning Outcomes
- Describe the process of cell reprogramming.
- Understand the critical steps in iPSC differentiation into different cells.
- Provide a global view on the current and future clinical and research applications of IPS cells.
- Discuss ethical aspects of iPS research and clinical applications.
Assessments
This module's usual assessment procedures, outlined below, may be affected by COVID-19 countermeasures. Current students should check Blackboard for up-to-date assessment information.
Module Director
Research Profile
| EmailLecturers / Tutors
Reading List
-
"Induced Pluripotent Stem (iPS) Cells: Methods and Protocols (Methods in Molecular Biology)" by n/a
ISBN: 1493930540.
The above information outlines module MD1529: "Induced Pluripotent Stem Cell Therapy" and is valid from 2021 onwards.
Note: Module offerings and details may be subject to change.
Optional
RPL030:
Recognised Prior Learning
RPL030: Recognised Prior Learning
Semester 1 and Semester 2 | Credits: 30
Assessments
This module's usual assessment procedures, outlined below, may be affected by COVID-19 countermeasures. Current students should check Blackboard for up-to-date assessment information.
Module Director
Research Profile
| EmailThe above information outlines module RPL030: "Recognised Prior Learning " and is valid from 2020 onwards.
Note: Module offerings and details may be subject to change.
Optional
RPL040:
Recognised Prior Learning
RPL040: Recognised Prior Learning
Semester 1 and Semester 2 | Credits: 40
Assessments
This module's usual assessment procedures, outlined below, may be affected by COVID-19 countermeasures. Current students should check Blackboard for up-to-date assessment information.
Module Director
Research Profile
| EmailThe above information outlines module RPL040: " Recognised Prior Learning " and is valid from 2020 onwards.
Note: Module offerings and details may be subject to change.
Optional
RPL020:
Recognised Prior Learning
RPL020: Recognised Prior Learning
Semester 1 and Semester 2 | Credits: 20
Assessments
This module's usual assessment procedures, outlined below, may be affected by COVID-19 countermeasures. Current students should check Blackboard for up-to-date assessment information.
Module Director
Research Profile
| EmailThe above information outlines module RPL020: "Recognised Prior Learning " and is valid from 2020 onwards.
Note: Module offerings and details may be subject to change.
Optional
RPL010:
Recognised Prior Learning
RPL010: Recognised Prior Learning
Semester 1 and Semester 2 | Credits: 10
Assessments
This module's usual assessment procedures, outlined below, may be affected by COVID-19 countermeasures. Current students should check Blackboard for up-to-date assessment information.
Module Director
Research Profile
| EmailThe above information outlines module RPL010: "Recognised Prior Learning " and is valid from 2020 onwards.
Note: Module offerings and details may be subject to change.
Optional
MD1528:
First in Human, Early Phase Clinical Trials
MD1528: First in Human, Early Phase Clinical Trials
Semester 1 | Credits: 10
This course will introduce researchers to the fundamental elements necessary to conduct First in Man, Early Phase Research in adherence to Good Clinical Practice guidelines using didactic and practical teaching, experiential learning ,inquiry-based and a cooperative learning approach. Researchers will be guided though the meaning of early phase research, study design, safety and clinical oversight, statistical considerations, emergency training, biological specimen management and clinical site preparation with the objective to enable researchers conduct early phase research to standards that surpass audit and inspection requirement.
(Language of instruction: English)
Learning Outcomes
- Understand and describe the process of translating novel drug/ device from the bench to the bedside
- Draft essential documents necessary for the conduct of phase 1 FIM Clinical Trials
- Describe dose escalation and dose expansion
- define and differentiate pharmacokinetics and pharmacodynamics and the implications of biological specimen management
- Identify challenges of conducting phase 1 trials and methods to overcome these
- demonstrate an in-depth knowledge of measures to ensure patient safety which includes safety event clinical management, data capture and reporting, Data Safety Monitoring Board Coordination, Investigator Brochure and Data Safety Update Reporting
Assessments
This module's usual assessment procedures, outlined below, may be affected by COVID-19 countermeasures. Current students should check Blackboard for up-to-date assessment information.
Module Director
Research Profile
| EmailLecturers / Tutors
The above information outlines module MD1528: "First in Human, Early Phase Clinical Trials" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.
Optional
MD1541:
Harnessing the Basic Biology of Cancer for Development of Novel Therapeutics
MD1541: Harnessing the Basic Biology of Cancer for Development of Novel Therapeutics
Semester 1 | Credits: 10
This module will cover the molecular biology of cancer and how this knowledge drives development of treatment strategies. Learners will be introduced to key components of the translational paradigm, from laboratory-based experimentation to development of targeted therapies for cancer. The importance of Biobanks for clinical research will be highlighted, and the core aspects required discussed. The potential to use mesenchymal stem cells and their secreted vesicles for cancer therapy will be covered, along with advances in the field towards clinical application. [Please note CAR-T/immune cells are covered in MD1522 and will not form part of this module]
(Language of instruction: English)
Learning Outcomes
- Describe key pathways involved in cancer development and progression, and the treatment strategies that target these specific pathways
- Describe each stage of the Translational Paradigm, from target discovery through to changing standard of care
- Define the key components of a clinically relevant Biobank, highlighting the ethical and infrastructural requirements
- Describe the potential for clinical application of Mesenchymal Stem Cells as targeted Cancer therapeutics, and the challenges yet to be overcome
- Demonstrate an understanding of the potential of Extracellular Vesicles for Cancer detection and Therapy
Assessments
This module's usual assessment procedures, outlined below, may be affected by COVID-19 countermeasures. Current students should check Blackboard for up-to-date assessment information.
Module Director
Research Profile
| EmailThe above information outlines module MD1541: "Harnessing the Basic Biology of Cancer for Development of Novel Therapeutics" and is valid from 2020 onwards.
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