Cellular Manufacturing and Therapy (MSc)

Applications and Selections

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

• Project managers from Cell Medica UK host a CV and interview skills workshop
• Bioreactor workshop hosted by Terumo technicians provided training on novel equipment.
• Guest lecturing from Biostor Ireland on cell bank storage and worldwide distribution for scientific research and clinical application.  
• Staff from ONK Therapeutics providing immunotherapy practical activities, upskilling students in non-adherent cell culture, characterization and cryopreservation.
• Dissertation placements hosted by Regeneron, Avectas, Intas Pharmaceuticals, Aerogen, Charles River, Stempeutics, Galway Blood and Tissue Establishment (GBTE), Centre for Cellular Manufacturing Ireland, etc.

Academic Collaboration

• Lecturing and workshops provided by the scientists within the Regenerative Medicine Institute specializing in discovering novel applications for cellular therapies and understanding their mechanism of action
• Lecturing and gowning activities by the Centre for Cell Manufacturing Ireland who produce cellular therapies for clinical application
• Guest lecturing visionaries in the field, such as Prof. Martin Leahy (Chair of Applied Physics at NUIG), emphasizing the advantages of multidisciplinary collaboration to investigate biologic queries
• Dissertation placements hosted by scientists and primary investigators including Dr. Roisin Dwyer (cellular therapy for breast cancer), Dr. Kasia Whysall (muscle-derived progenitor therapy), Dr. Daniel O’Toole (cellular therapy for acute repertory distress) or at Hebei Medical University in China by Dr. Jun Ma (cellular therapy for neural disorders)

Collaborations with Clinicians and Patients

• Lecturing and mentoring by scientist clinicians, the first in Ireland to translate cellular therapies to clinical trials
• Assessment of scientific poster presentations describing ongoing clinical trials by the clinical trial recruitment specialists at (Galway University Hospitals)
• Module coordination by Dr. Veronica McInerney (Cellular Therapy Clinical Trials Manager), offering a unique insight into initiating first in man clinical investigations
• Dissertation placements hosted by Cancer Trials Ireland (CTI), Prof. Timothy O’Brien (coordinator of two cellular therapy clinical trials) and Prof. O’Dwyer (coordinator of trials in multiple myeloma)

Mr Andrew Finnerty

Dip., MBA

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Requirements and Assessment

Glossary of Terms

Year 1 (90 Credits)

RequiredMD1521: 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

1. 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.
2. Recognize and evaluate advancements in bioreactor technology, strategic scale-up technologies and process design to improve biomanufacturing processes.
3. Identify advances in technique, reagents and procedures, applying them to good manufacturing practice policies in the production of a cellular therapy.
4. Master the calculations associated with cellular expansion profile, anticipated yield, etc.

Assessments

• Continuous Assessment (100%)

Teachers

•  CYNTHIA COLEMAN 🖂
  

RequiredMD1522: Cellular Immunotherapy

MD1522: Cellular Immunotherapy

Semester 1 | Credits: 10

This module offers an in-depth exploration of cellular immunotherapy, a revolutionary approach in medicine that extends beyond malignant disorders to include autoimmune diseases, infectious diseases, and more. It begins with foundational knowledge in immunology and immune cell biology, emphasizing the diversity and function of immune cells. The course delves into the principles and mechanisms of cellular immunotherapy, highlighting the engineering and modification of immune cells, such as CAR T cells and TCR-modified T cells, for therapeutic purposes. Participants will explore the broad applications of cellular immunotherapy, examining its role in not only oncology but also in treating autoimmune conditions and infectious diseases, with a focus on the latest clinical applications and case studies. The module addresses the complexities of manufacturing, regulatory considerations, and the ethical landscape surrounding cellular therapies. It also looks ahead to emerging trends, including the use of "off-the-shelf" immune cell products, preparing participants for the future of immunotherapy across various medical disciplines. Designed for healthcare professionals and researchers, this module aims to equip attendees with a comprehensive understanding of cellular immunotherapy's potential, fostering innovation and application in diverse therapeutic areas.
(Language of instruction: English)

Learning Outcomes

1. Introduction to Cancer Immunotherapy: Understand the concept and historical development of cancer immunotherapy. Identify key principles of immunotherapy, including the role of tumor antigens and immune system mechanisms in recognizing and targeting cancer.
2. The Immune System and Cell Therapy: Basic Biology and Immunological Principles: Grasp the basic biology of the immune system, including the types and functions of immune cells. Comprehend the immunological principles underlying cell-based therapies and the immune system's response to cancer.
3. Engineering Tumor Microenvironment for Cancer Immunotherapy: Understand the significance of the tumor microenvironment in cancer immunotherapy. Learn about the strategies employed to modify the tumor microenvironment to enhance immunotherapy effectiveness.
4. T Cell Receptors and CAR T Cells: Engineering Approaches to Cancer Immunotherapy: Gain insights into the engineering approaches used to modify T cells for cancer immunotherapy. Understand the principles of T cell receptor (TCR) engineering and chimeric antigen receptor (CAR) T cell therapy.
5. CAR T-Cell Therapy: Manufacturing and Clinical Applications: Learn about the manufacturing processes of CAR T cell therapy. Understand the clinical applications and implications of CAR T cell therapy in cancer treatment.
6. T regulatory lymphocytes and Tumor-Infiltrating Lymphocytes (TILs) and Clinical Applications: Comprehend the roles of T regulatory lymphocytes and tumor-infiltrating lymphocytes (TILs) in cancer immunotherapy. Understand the clinical applications and therapeutic potential of T Reg and TILs in cancer treatment.
7. Dendritic Cell Therapy and Its Current Status: Understand the use and mechanism of action of dendritic cells in cancer immunotherapy. Learn about the current status and clinical applications of dendritic cell therapy.
8. Immunological Aspects of Stromal Cells/Stromal Cell Therapies in Colorectal and Other Solid Cancers I & II: Grasp the immunological aspects and therapeutic potential of stromal cells in colorectal and other solid cancers. Understand the challenges and strategies in developing stromal cell therapies for solid tumors.
9. Natural Killer (NK) Cells and Their Potential for Cancer Immunotherapy: Learn about the role and mechanisms of natural killer (NK) cells in the immune response to cancer. Understand the potential clinical applications of NK cells in cancer immunotherapy.
10. Cancer Vaccines: Types and Approaches: Gain an overview of the different types of cancer vaccines and their development approaches. Understand the principles, challenges, and potential of cancer vaccines in immunotherapy.
11. Future Directions in Cancer Immunotherapy: Challenges and Opportunities: Explore the current challenges and future opportunities in cancer immunotherapy. Understand the impact of emerging technologies, clinical trials, and personalized treatment approaches on the field.

Assessments

• Continuous Assessment (40%)
• Oral, Audio Visual or Practical Assessment (20%)
• Department-based Assessment (40%)

Teachers

•  MICHAEL O'DWYER 🖂
  
•  MATTHEW DALLAS GRIFFIN 🖂
  
•  Janusz Krawczyk 🖂
  

RequiredMD1523: 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

1. 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.
2. Discuss, present and defend their 1) contribution to an organization during a 4 month work placement or 2) literature review and critical analysis.
3. Demonstrate competence and professionalism in oral and written communications.

Assessments

• Continuous Assessment (100%)

Teachers

•  CYNTHIA COLEMAN 🖂
  

RequiredMD1524: 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

1. Discuss the regulations and guidelines for cell isolation, freezing, thawing and administration of cellular products
2. Recognise key aspects of National, European and International regulatory affairs.
3. Describe key aspects of planning, costing of goods, operations management, health systems and policy (reimbursement)
4. Design of GCP-compliant preclinical studies
5. Design of bioprocesses for autologous/allogeneic therapies
6. Perform risk-based assessment of GMP-compliant processes for the production of cell-based therapies.
7. Discuss compliance and accreditation procedure for quality assurance standards (JACIE and others).

Assessments

• Continuous Assessment (55%)
• Oral, Audio Visual or Practical Assessment (15%)
• Department-based Assessment (30%)

Teachers

•  CYNTHIA COLEMAN 🖂
  
•  ANDREW FINNERTY 🖂
  
•  AOIFE LYONS 🖂
  
•  Janusz Krawczyk 🖂
  

Reading List

1. "Cell Therapy: cGMP Facilities and Manufacturing" by Adrian Gee
   Publisher: SPRINGER
2. "Guide to Cell Therapy GxP: Quality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical Environments" by J. Vives
3. "Advances In Pharmaceutical Cell Therapy: Principles Of Cell-Based Biopharmaceuticals" by R. Huss,
4. "Cell Therapy : cGMP Facilities and Manufacturing" by Adrian Gee
   Publisher: Springer
5. "WHO good manufacturing practices for sterile pharmaceutical products" by World Health Organisation, Annex 6

RequiredMD1526: 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

1. Compare and contrast the qualities of progenitor cells from various tissue sources in relation to their intended application.
2. Demonstrate practical competence in mesenchymal stromal culture expansion and cryopreservation.
3. Evaluation of the current literature regarding the safety and efficacy of mesenchymal stromal cells in pre-clinical and clinical applications.

Assessments

• Continuous Assessment (100%)

Teachers

•  CYNTHIA COLEMAN 🖂
  

RequiredMD1529: 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

1. Describe the process of cell reprogramming.
2. Understand the critical steps in iPSC differentiation into different cells.
3. Provide a global view on the current and future clinical and research applications of IPS cells.
4. Discuss ethical aspects of iPS research and clinical applications.

Assessments

• Continuous Assessment (55%)
• Oral, Audio Visual or Practical Assessment (15%)
• Department-based Assessment (30%)

Teachers

•  CYNTHIA COLEMAN 🖂
  
•  ANDREW FINNERTY 🖂
  
•  SANBING SHEN 🖂
  
•  Janusz Krawczyk 🖂
  

Reading List

1. "Induced Pluripotent Stem (iPS) Cells: Methods and Protocols (Methods in Molecular Biology)" by n/a
   ISBN: 1493930540.

OptionalMD1541: 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

1. Describe key pathways involved in cancer development and progression, and the treatment strategies that target these specific pathways
2. Describe each stage of the Translational Paradigm, from target discovery through to changing standard of care
3. Define the key components of a clinically relevant Biobank, highlighting the ethical and infrastructural requirements
4. Describe the potential for clinical application of Mesenchymal Stem Cells as targeted Cancer therapeutics, and the challenges yet to be overcome
5. Demonstrate an understanding of the potential of Extracellular Vesicles for Cancer detection and Therapy

Assessments

• Continuous Assessment (100%)

Teachers

•  RÓISÍN DWYER 🖂
  

OptionalMD1600: Bio-Ethics

MD1600: Bio-Ethics

Semester 1 | Credits: 10

This module will provide a comprehensive introduction to bio-ethics in the context of clinical research sciences. The module will instil the importance of balancing the need to advance our knowledge of medicine against the legal and ethical mandate to protect society.
(Language of instruction: English)

Learning Outcomes

1. Evaluate ethical issues from given scenarios and thus demonstrate a capacity to apply across a broad spectrum.
2. Evaluate the ethics relating to biobanking and current legislation around informed consent and ethical approval.
3. Consider the ethics of previous practice and hence demonstrate a capacity to review processes for the advancement of future endeavour.
4. Evaluate legislation practices and protocols, given consideration to all participants and, create a framework for disseminating learning to both peers and non-peers.

Assessments

• Continuous Assessment (80%)
• Department-based Assessment (20%)

Teachers

•  RÓISÍN DWYER 🖂
  
•  EVA ERZSEBET SZEGEZDI 🖂
  
•  EDEL MURPHY 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

OptionalMD550: Informatics I : Retrieval & Appraisal of Scientific Literature

MD550: Informatics I : Retrieval & Appraisal of Scientific Literature

Semester 1 | Credits: 10

This module serves as an introduction to scientific research and the use of evidence based medicine in clinical settings. Learners are introduced to the key components of research and the steps needed to formulate a research question and how to use electronic databases.
(Language of instruction: English)

Learning Outcomes

1. Perform competent electronic database and internet searches.
2. Critically appraise a research paper
3. Use EndNote to store and organise references
4. Construct a literature review and research proposal

Assessments

• Continuous Assessment (100%)

Teachers

•  NICOLA MILLER 🖂
  
•  MICHEÁL NEWELL 🖂
  

OptionalSI5100: Gene Therapy

SI5100: Gene Therapy

Semester 1 | Credits: 10

In this module we will explore nucleic acid based diseases and therapeutics of all types, which is of particular relevance as many gene therapy medicines are currently completing the translational path to approval for clinical use. Lectures will deep dive into basic nucleic acid biology, diseases that may be amenable to gene therapy, synthetic nucleotide chemistry, transfection protocols, viral vectors and CRISPR technologies. There will also be discussion of genetic modification of cell therapies and scale up manufacturing techniques to get these potential medicines to the clinic in quality controlled and human sized doses. Completed and current clinical trials and approved gene therapy medicines will be covered in depth. There will also be laboratory pra
(Language of instruction: English)

Learning Outcomes

1. Describe the fundamentals of nucleic acid biology and translation to protein. Describe genetic disorders and how these might be amenable to gene therapy medicines
2. Compare and contrast the relative merits of different nucleic acid transfer technologies and how they might benefit the patient, including direct therapy and modifications of cell therapies.
3. Detail the practical considerations required when manufacturing, transporting and administering gene therapy medicines for deployment to the clinic.
4. Apply fundamental knowledge of gene therapy technologies to clinical trials, with a focus on the previous body of literature to support specific modalities and interventions for specific diseases or patients.

Assessments

• Continuous Assessment (70%)
• Oral, Audio Visual or Practical Assessment (30%)

Teachers

•  FRANK BARRY 🖂
  
•  LINDA HOWARD 🖂
  
•  TIMOTHY O'BRIEN 🖂
  
•  THOMAS RITTER 🖂
  
•  ANDREW FINNERTY 🖂
  
•  AMY BURKE 🖂
  
•  KARL MCCULLAGH 🖂
  
•  DANIEL PATRICK O'TOOLE 🖂
  
•  MATTHEW DALLAS GRIFFIN 🖂
  
•  SEAN DANIEL MCCARTHY 🖂
  
•  CLAIRE MASTERSON 🖂
  
•  Katarzyna Whysall 🖂