SCI09008 2023 Introduction to Advanced Therapy Medicinal Products
Full Title
Introduction to Advanced Therapy Medicinal Products
Transcript Title
Introduction to ATMPs
Code
SCI09008
Attendance
N/A %
Subject Area
SCI - Science
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2023 - Full Academic Year 2023-24
End Term
9999 - The End of Time
Author(s)
Ailish Breen
Programme Membership
SG_SATMP_S09 202300 Level 9 Certificate in ATMP Cell Manufacturing
SG_SATMQ_S09 202300 Postgraduate Certificate in Advanced Therapy Medicinal Products (ATMP) Cell Manufacturing
SG_SATMR_M09 202300 Master of Science in Advanced Therapy Medicinal Products (ATMP) Cell Manufacturing
SG_SATMP_M09 202300 Master of Science in Advanced Therapy Medicinal Products (ATMP) Technology and Manufacturing
SG_SATMP_O09 202300 Postgraduate Diploma in Science in Advanced Therapy Medicinal Products (ATMP) Technology and Manufacturing
Description
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
On completion of this module the learner will/should be able to;
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 origin and examine associated ethical and societal issues
5.
Examine the concept of a viral vector for gene therapy delivery and design the associated manufacturing flow
Teaching and Learning Strategies
This Module will be delivered online part time.
A virtual learning environment (e.g. Moodle) will be used as a repository of educational resources and as a means of assessment. Self directed, student centred, independent learning is a core aspect through completion of module coursework. Some aspects of flipped learning, groupwork, case studies and other active learning methodologies will be incorporated into the module.
Module Assessment Strategies
The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQs, project assignments, essays, enquiry based learning, oral presentations, viva’s etc.
Repeat Assessments
Repeat assignments will be assigned as per the current Marks and Standards
Indicative Syllabus
1. Demonstrate detailed knowledge and understanding of the background to ATMPs including current and emerging product types.
- Definition of ATMPs, historical context of ATMP development, description of product classes, cell therapy description
2. Describe the manufacturing process required for allogeneic and autologous cell therapies (incl. ex vivo gene therapies)
- Concept of autologous and allogeneic therapies, closed V open loop manufacturing, current and emerging technologies
3. Evaluate current / emerging cell-based therapies for the treatment of inflammation, tissue repair, and cancer and examine associated ethical and societal issues
- Cellular immunotherapy, CART cells, CAR NK cells and their subtypes and emerging cellular therapies
- Research ethics and ethical principles applied to cell therapies
4. Evaluate current / emerging gene therapy / editing for the treatment of both genetic disorders and other disorders of non-genetic origin and examine associated ethical and societal issues
- Ex vivo gene therapy, viral vectors for gene therapy, viral vector classes and their usage, manufacturing of viral vectors, and gene editing through nucleases.
- Research ethics and ethical principles applied to gene therapies
5. Examine the concept of a viral vector for gene therapy delivery and design the associated manufacturing flow
- Current and emerging technologies for manufacturing viral vectors
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Assignment | Coursework Assessment | Written Report/Essay | 25 % | Week 6 | 1,2 |
| 2 | Assignment | Coursework Assessment | Oral Exam/Presentation | 35 % | Week 8 | 3,4 |
| 3 | Long Answer Quiz | Coursework Assessment | Assessment | 40 % | Week 11 | 5 |
Online Learning Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Online | Lecture | 2 | Weekly | 2.00 |
| Independent Learning | Not Specified | Independent learning | 4 | Weekly | 4.00 |
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours
Required & Recommended Book List
Recommended Reading
2020-02-10 Second Generation Cell and Gene-Based Therapies Academic Press
ISBN 0128120347 ISBN-13 9780128120347
2020-02-10 Second Generation Cell and Gene-Based Therapies Academic Press
ISBN 0128120347 ISBN-13 9780128120347
Second Generation Cell and Gene-Based Therapies: Biological Advances, Clinical Outcomes, and Strategies for Capitalisation serves as the only volume to the market to bridge basic science, clinical therapy, technology development, and business in the field of cellular therapy/cytotherapy. After more than two decades of painstaking fundamental research, the concept of therapeutic cells (stem cells, genes, etc.), beyond the concept of vaccines, is reaching clinical trial, with mounting confidence in the safety and efficacy of these products. Nonetheless, numerous incremental technical advances remain to be achieved. Thus, this volume highlights the possible R&D paths, which will ultimately facilitate clinical delivery of cutting edge curative products. The next waves of innovation are reviewed in depth for hematopoietic stem cells, mesenchymal stem cells, tissue engineering, CAR-T cells, and cells of the immune system, as well as for enabling technologies such as gene and genome editing. Additionally, deep dives in product fundamentals, history of science, pathobiology of diseases, scientific and technological bases, and financing and technology adoption constraints are taken to unravel what will shape the cytotherapy industry to the horizon 2025 and beyond. The outcome is not simply a scientific book, but a global perspective on the nascent field combining science, business, and strategic fundamentals.
Recommended Reading
2020-11-03 Personalized Immunotherapy for Tumor Diseases and Beyond Bentham Science Publishers
ISBN 9789811482731 ISBN-13 981148273X
2020-11-03 Personalized Immunotherapy for Tumor Diseases and Beyond Bentham Science Publishers
ISBN 9789811482731 ISBN-13 981148273X
This book introduces personalized immunotherapy with multi-dimensional models of analysis to determine the best plan for immunotherapy of patients. The book introduces readers to some basic concepts which lay the foundation for personalized immunotherapy: the development of a major histocompatibility complex (MHC), the genome profile of T cells and tumor cells, and genome-wide association studies. Chapters also cover special topics such as new immunoassay methods related to personalized immunotherapy and targeted immunotherapy which are geared towards familiarizing readers with current research practices. Focusing on the central theme of personalized immunotherapy, the authors provide a wealth of information about T-cell screening, tumor neoantigen cloning, primary tumor cell culture for T-cell cloning, bioinformatics strategies for understanding T-cell and primary tumor cell biology and function, and new developments in research on adoptive T-cell immunotherapy. These developments include T-cell gene therapy and T-cell gene editing, transgenic T-cells for increasing affinity to tumor cells such as CAR T-cells and TCR T-cells, and the systematic modeling of polyclonal specific T-cells and biobank technology. Key Features: - Introduces readers to basic concepts in personalized medicine and immunotherapy - Presents current information about immunological assays used in research - Presents an overview of T cell immunotherapy and cloning techniques - Presents an overview of tumor cell bioinformatics and its role in immunotherapy - Includes new developments and references for personalized immunotherapy techniques (T-cell gene therapy and T-cell gene editing, transgenic T-cells which target CAR T-cells and TCR T-cells, and polyclonal T-cell modeling) - Includes a section on biobanking - Presents information in an easy-to-read format for a wide range of readers - Brings contributions from experts with over 30 years of experience in personalized immunotherapy Personalized Immunotherapy for Tumor Diseases and Beyond is an ideal handbook for medical professionals and students involved in personalized medicine, immunology and oncology. General readers interested in the new developments in these fields will also benefit from the information provided.
Recommended Reading
2021-02-28 Fast Facts: CAR T-Cell Therapy Karger Medical and Scientific Publishers
ISBN 9783318067415 ISBN-13 3318067415
2021-02-28 Fast Facts: CAR T-Cell Therapy Karger Medical and Scientific Publishers
ISBN 9783318067415 ISBN-13 3318067415
Chimeric antigen receptor (CAR) T cells are genetically engineered immune cells that can seek out and destroy cancer cells. The results from their use in cancer immunotherapy have been very promising, but treatment is often associated with frequent, serious short-term toxicities. 'Fast Facts: CAR-T Therapy' explains what CAR T cells are and how they were developed, discusses the results of clinical trials and the management of toxicities, and outlines future improvements and applications. It is ideal reading for any healthcare professional wanting to know more about this exciting therapeutic field. Table of Contents: CAR T cells Clinical application Practical aspects Future directions
Module Resources
Non ISBN Literary Resources
See recommended reading
Updated Literary Resources
Journal Resources
Relevent journals will be accessed throughout the module such as:
Cell, Stem cells, Gene therapy, Nature Medicine etc.
URL Resources
https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview
Other Resources
Additional Information