BIO07017 2019 Advanced Therapy Medicinal Products (ATMPs)

General Details

Full Title
Advanced Therapy Medicinal Products (ATMPs)
Transcript Title
Advanced Therapy Medicinal Pro
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
LIFE - Life Sciences
07 - NFQ Level 7
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Ailish Breen
Programme Membership
SG_SBIOM_B07 201900 Bachelor of Science in Biomedical Science SG_SMEDI_H08 201900 Bachelor of Science (Honours) in Science in Medical Biotechnology

This module is an introduction to the interdisciplinary field of advanced therapy medicinal products (ATMPs), which encompasses tissue engineering,and cell and gene based therapies. The latter are rapidly emerging as therapeutic approaches to treating disease / diseased tissues and genetic disorders in the biotechnology industry. This course will introduce advances in the fields of cell biology, material science, cell based medicine and gene based medicine and their relationship towards developing novel therapies.

Learning Outcomes

On completion of this module the learner will/should be able to;


Explain the fundamental principles in developing cell, gene and tissue engineered therapies.


Define the principal applications of advanced therapy medicinal products (ATMPs).


Analyse, evaluate and draw conclusions from data obtained in problem solving exercises.


Communicate effectively with peers on multi-disciplinary teams to attain a common goal.


Formulate and communicate judgements with regard to the ethical issues surrounding the use of stem cells, gene therapy and tissue engineered therapies to treat human diseases and disabilities.

Teaching and Learning Strategies

Teaching and learning strategies will include classroom based lectures, group work, case studies, practical demos, use of online resources and videos.  Methods of enquiry based learning will be utilised to enhance critical thinking skills when evaluating research, ethics and challenges.  Flipped/blended learning will be used in facilitation of case study analysis.

Module Assessment Strategies

Continuous assessment will be designed to maximise critical thinking skills and will take the form of team based assignments, reports, essays and some quizzes.  Formative assessment will include problem solving, data analysis and debates.   This module has an end of semester exam.

Repeat Assessments

Repeat assessment will be given as required.

Module Dependencies


Indicative Syllabus

  1. What is a biomaterial scaffold?  What types of biomaterials are used in tissue engineering and rationale for their choice. What biochemical and mechanical signals are involved in tissue engineering and rationale for their choice.  The role of a bioreactor.  Adult cell types and rationale for their choice.  Stem cell types and their roles.
  2.  The basis of gene therapy, vector choice and current research in gene based therapies.  The basis of cell based therapies, current research in advanced therapeutic medicinal products (ATMPs) and research and manufacturing success/challenges
  3. Regulatory challenges associated with ATMPs and case studies of preclinical trials / clinical trials and approved products
  4. Ethical issues associated with the research and use of ATMPs, including stem cell ethics.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
40 %
End of Semester / Year Formal Exam
60 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 MCQ Continuous Assessment Assessment 10 % Week 5 1,2
2 Project activities Continuous Assessment Assignment 30 % Week 9 3,4

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam UNKNOWN 60 % End of Term 1,2,3,4,5

Full Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Tiered Classroom Lecture 2 Weekly 2.00
Problem Based Learning Flat Classroom Problem Based Learning 1 Weekly 1.00
Independent Learning UNKNOWN Self Study 4 Weekly 4.00
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Required & Recommended Book List

Required Reading
2011 Cell and Tissue Engineering
ISBN 8674664083 ISBN-13 9788674664087

Cell and Tissue Engineering introduces the principles and new approaches in cell and tissue engineering. It includes both the fundamentals and the current trends in cell and tissue engineering, in a way useful both to a novice and an expert in the field. The book is composed of 13 chapters all of which are written by the leading experts. It is organized to gradually assemble an insight in cell and tissue function starting form a molecular nano-level, extending to a cellular micro-level and finishing at the tissue macro-level.

Required Reading
2013-10-17 Principles of Tissue Engineering Academic Press
ISBN 9780123983701 ISBN-13 0123983703

Now in its fourth edition, Principles of Tissue Engineering has been the definite resource in the field of tissue engineering for more than a decade. The fourth edition provides an update on this rapidly progressing field, combining the prerequisites for a general understanding of tissue growth and development, the tools and theoretical information needed to design tissues and organs, as well as a presentation by the worlds experts of what is currently known about each specific organ system. As in previous editions, this book creates a comprehensive work that strikes a balance among the diversity of subjects that are related to tissue engineering, including biology, chemistry, material science, and engineering, among others, while also emphasizing those research areas that are likely to be of clinical value in the future. This edition includes greatly expanded focus on stem cells, including induced pluripotent stem (iPS) cells, stem cell niches, and blood components from stem cells. This research has already produced applications in disease modeling, toxicity testing, drug development, and clinical therapies. This up-to-date coverage of stem cell biology and other emerging technologies such as brain-machine interfaces for controlling bionics and neuroprostheses is complemented by a series of new and updated chapters on recent clinical experience in applying tissue engineering, as well as a new section on the application of tissue-engineering techniques for food production. The result is a comprehensive textbook that will be useful to students and experts alike. Includes new chapters on biomaterial-protein interactions, nanocomposite and three-dimensional scaffolds, skin substitutes, spinal cord, vision enhancement, and heart valves Offers expanded coverage of adult and embryonic stem cells of the cardiovascular, hematopoietic, musculoskeletal, nervous, and other organ systems Full-color presentation throughout

Required Reading
2013-10-31 Gene therapy Elsevier
ISBN 9781908818645 ISBN-13 1908818646

Gene therapy is emerging as a new class of therapeutics for the treatment of inherited and acquired diseases. However, poor cellular uptake and instability of DNA in the physiological milieu limits its therapeutic potential, hence a vector which can protect and efficiently transport DNA to the target cells must be developed. Nanotechnology-based non-viral vectors have been proposed as potential candidates. Various polymeric nanoparticles have been shown to be suitable, with high cellular uptake efficiencies and reduced cytotoxicity. These delivery vectors form condensed complexes with DNA which result in shielding against enzymatic degradation and enhanced cellular targeting. Advantages including easy manipulatibility, high stability, low cost and high payload, mean that nanoparticles from various polymers have been exploited. Gene therapy gives a systematic account of the many aspects of nanotechnology mediated gene therapy, from the preparation of nanoparticles to physicochemical characterization, and follows with applications in in vitro and in vivo models. This book emphasizes the various aspects of nanotechnology-based gene therapy, with initial chapters detailing the tools and techniques available for preparation and in vitro and in vivo characterization of nanoparticles. Later chapters provide exhaustive details on polymeric systems employed for gene therapy. Provides an overview of nanotechnology applications in gene therapy, from preparation of nanoparticles to in vitro and in vivo studies Details the tools and techniques available for preparation, characterization and in vitro and in vivo study of nanoparticles Details the limitations of nanoparticle-mediated gene therapy and proposes ways in which they may be overcome

Module Resources

Non ISBN Literary Resources


Journal Resources

Tissue Engineering (Mary Ann Liebert)

Journal of Tissue Engineering (SAGE)

Biomaterials  (Springer)

Gene therapy (Nature)


URL Resources

ATMP Handbook:


Other Resources


Additional Information