Cellular Manufacturing and Therapy (MSc)

Program Overview

The MSc in Cellular Manufacturing and Therapy at University of Galway is a one-year program that provides students with the skills and knowledge necessary for a career in the rapidly growing field of cellular therapy. The program balances the scientific aspects of cellular therapy with bioprocessing and manufacturing regulation, and offers optional modules in cancer biology, business, clinical trials, and bio-ethics. Graduates are well-prepared for careers in the cellular therapy field, including plant technologists, production assistants, manufacturing biotech associates, and research assistants.

Program Outline

MSc (Cellular Manufacturing and Therapy) - University of Galway

Degree Overview:

The MSc in Cellular Manufacturing and Therapy is a one-year full-time program designed to provide students with the skills and knowledge necessary for a career in the rapidly growing field of cellular therapy. It is the first program of its kind worldwide and was awarded the Best New Postgraduate Course 2020 by GradIreland Higher Education Awards.

Objectives:

The program aims to:

• Provide formal training in cellular bioprocessing for clinical application.
• Cultivate a rigorous scientific underpinning for the development of a cellular therapy.

Program Description:

The 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. The program includes:

• Practical skills development: Beyond classroom laboratory activities, students participate in workshops in sterile gowning and a 4-month work or laboratory placement, gaining research or enterprise-centric skills.
• Unique position: The program offers unique opportunities in support of a career in cellular therapy, including:
• Instruction in the clinical-grade manufacturing of therapeutic cells for clinical application.
• 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 work placements where students are embedded in a host environment corresponding to their career of choice.
• New skills development: Students develop both technical and transferable skills through practical activities, module assessments, workshops, and group activities.
Technical skills include 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 include meeting 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.

Outline:

The program is offered in a 1-year full-time format, a 2-year part-time format, or in "microcredits" for employed individuals. Modules are available in a variety of formats, including lecture-based, flipped classroom, blended learning, and fully online. The program is offered as an MSc program (90 ECTS), a postgraduate diploma program (60 ECTS), or a postgraduate certificate program (30 ECTS). Both the MSc and postgraduate diploma are available in a one-year full-time capacity or 2-year part-time capacity.

Year 1 (90 Credits):

Required Modules:

• MD1521: Cellular Manufacturing I (Semester 1, 10 Credits): This module covers tissue procurement, cellular expansion and biobanking, and advances in bioreactor technology.
It emphasizes the production of advanced medicinal products and provides a reference for the biomanufacturing process underpinning the production of cellular therapeutics.
• MD1522: Cellular Immunotherapy (Semester 1, 10 Credits): This module focuses on adoptive cell therapy (ACT), particularly CAR T cell therapy, covering its history, strategies for gene delivery, cell production platforms and processes, clinical results, challenges, and future perspectives.
It also includes an introduction to hematopoietic stem cell transplantation.
• MD1523: Cellular Manufacturing and Therapy Dissertation (15 months long, 30 Credits): This module involves a 4-month work experience program in an academic or industrial setting or a literature-based review of an area relevant to cellular manufacturing and therapy.
Students develop technical writing, peer review, and oral and written presentation skills.
• MD1524: Cellular Manufacturing II (Semester 2, 10 Credits): This module covers the regulatory environment, national and international requirements, management of cellular manufacturing facilities, clinical trials design, trial approval, and Good Clinical Practice requirements.
• MD1526: Mesenchymal Stromal Cell Therapy (Semester 2, 10 Credits): This module covers the biology of mesenchymal stromal cells (MSCs), their therapeutic applications, and recent advancements in MSC preclinical trials.
It includes hands-on laboratory-based skills, including cell culture.
• MD1529: Induced Pluripotent Stem Cell Therapy (Semester 2, 10 Credits): This module provides theoretical and practical background on iPS cell research, including derivation, maintenance, characterization, expansion, and differentiation.
It covers ethical aspects of iPS research and therapies, its role in disease modeling, regeneration, and therapy of hereditary and acquired disorders.

Optional Modules:

• MD1527: Independent Study (Semester 1, 10 Credits): This module involves an in-depth desk-based research activity in an area related to cellular manufacturing and therapy under the supervision of an assigned mentor.
• RPL030, RPL040, RPL020, RPL010: Recognised Prior Learning (Semester 1 and Semester 2, 30, 40, 20, 10 Credits): These modules allow students to receive credit for prior learning.
• MD1528: First in Human, Early Phase Clinical Trials (Semester 1, 10 Credits): This module introduces researchers to the fundamental elements necessary to conduct First in Man, Early Phase Research in adherence to Good Clinical Practice guidelines.
• MD1541: Harnessing the Basic Biology of Cancer for Development of Novel Therapeutics (Semester 1, 10 Credits): This module covers the molecular biology of cancer and how this knowledge drives development of treatment strategies.
• MD1600: Bio-Ethics (Semester 1, 10 Credits): This module provides a comprehensive introduction to bio-ethics in the context of clinical research sciences.
• MD550: Informatics I: Retrieval & Appraisal of Scientific Literature (Semester 1, 10 Credits): This module serves as an introduction to scientific research and the use of evidence-based medicine in clinical settings.
• MG529: Introduction To Business (Semester 1, 10 Credits): This module provides an introduction to business principles.

Assessment:

Assessment methods vary depending on the module and include:

• Continuous Assessment
• Oral, Audio Visual or Practical Assessment
• Department-based Assessment

Teaching:

The program is delivered by experts in the field of cellular manufacturing and pre-clinical research supporting the development of new therapies. The teaching team includes:

• Centre for Cell Manufacturing Ireland (CCMI) team: Active instructors in the Cellular Manufacturing 1 and 2 modules.
• Professors O’Brien, Barry and Griffin: Pioneering coordinators of the first cellular therapy clinical trials in Ireland, delivering an in-depth lecture series in the Mesenchymal Stem Cell Therapy module.
The program utilizes a variety of teaching methods, including:
• Lectures: Delivered by experts in the field.
• Workshops: Provide hands-on experience in sterile gowning and other techniques.
• Group activities: Foster collaboration and teamwork.
• Dissertation placements: Provide students with real-world experience in research or industry settings.

Careers:

Graduates of the program are well-prepared for a variety of careers in the cellular therapy field, including:

• Plant technologists
• Production assistants
• Manufacturing biotech associates
• Cell culture scientists
• Cell culture technical support
• Quality assurance and assay development
• Research assistants
Potential employers include:
• Takeda
• Autolus
• University of Galway
• Fuji Diosynth Biotechnologies
• Avectas
• Abace-Biology
• Charles River laboratories

Other:

• The program has strong industry collaborations, with guest lectures and workshops provided by companies such as Cell Medica UK, Terumo, Biostor Ireland, ONK Therapeutics, Regeneron, Avectas, Intas Pharmaceuticals, Aerogen, Charles River, Stempeutics, Galway Blood and Tissue Establishment (GBTE), Centre for Cellular Manufacturing Ireland, etc.
• The program also has strong academic collaborations, with lecturing and workshops provided by scientists within the Regenerative Medicine Institute, the Centre for Cell Manufacturing Ireland, and other experts in the field.

Fees: EU €8,890 full-time Fees: Tuition €8,750 full-time; p.a. 2024/25 Fees: Student levy €140 full-time; p.a. 2024/25 Fees: Non EU €23,000 p.a. (€23,140 p.a. including levy) 2024/25 Student levy €140—payable by all students and is not covered by SUSI. Further detail here.