BIOC09003 2023 Biocontamination Monitoring & Control in ATMP Manufacturing
Full Title
Biocontamination Monitoring & Control in ATMP Manufacturing
Transcript Title
ATMP Biocontamination Control
Code
BIOC09003
Attendance
N/A %
Subject Area
BIOC - Biochemistry
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, Macdara Bodeker
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
The Biocontamination Monitoring & Control module introduces the concepts and issues pertaining to biocontamination control with respect to the culturing of mammalian cells and preparation of viral stocks for ATMP manufacture. The module outlines the unique challenges presented when developing ATMPs which due to their short shelf life require the use of rapid methods of detection when screening for contaminants.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Describe the basics of biocontamination control and best practice
2.
Explain the different types of rapid methods available for screening for the presence of bio contaminants including endotoxins viruses and mycoplasma in raw materials, cell and viral stocks.
3.
Develop a biocontamination control strategy with respect to raw material release and allogeneic donor recruitment.
4.
Problem-solve simulated quality issues through case studies of biocontamination incidents.
5.
Understand the regulatory expectations with respect to biocontamination control when manufacturing ATMPs.
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. MCQ's, project assignments, essays, oral presentations, vivas etc.
Repeat Assessments
Repeat continuous assessment of the failed elements in line with marks and standards and the quality manual.
Indicative Syllabus
1. Introduction to biocontamination control and best practice
2. Rapid methods available for screening for the presence of bio contaminants including endotoxins viruses and mycoplasma in raw materials, cell and viral stocks.
3. How to develop a biocontamination control strategy with respect to raw material release and allogeneic donor recruitment.
4. Case studies of biocontamination incidents.
5. Regulatory expectations with respect to biocontamination control when manufacturing ATMPs.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | MCQ 1 | Coursework Assessment | Assessment | 15 % | Week 5 | 1,2 |
| 2 | MCQ 2 | Coursework Assessment | Assessment | 15 % | Week 10 | 3,4 |
| 3 | LAQ 3 | Coursework Assessment | Closed Book Exam | 20 % | Week 12 | 1,2,3,4,5 |
| 4 | Mini-thesis | Project | Assignment | 40 % | End of Semester | 1,2,3,4,5 |
| 5 | Presentation & Viva | Project | Oral Exam/Presentation | 10 % | End of Semester | 1,2,3,4,5 |
Online Learning Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Online | Lecture/workshop | 2 | Weekly | 2.00 |
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours
Required & Recommended Book List
Recommended Reading
2015-09-15 Regulatory Aspects of Gene Therapy and Cell Therapy Products Springer
ISBN 9783319186184 ISBN-13 3319186183
2015-09-15 Regulatory Aspects of Gene Therapy and Cell Therapy Products Springer
ISBN 9783319186184 ISBN-13 3319186183
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Module Resources
Non ISBN Literary Resources
Updated Literary Resources
Journal Resources
Students will be directed to read relevant journal articles from the journal Science, Cell, Stem Cells, etc. as appropriate
URL Resources
Other Resources
Students will be directed to up to date, relevant online resources as appropriate.
Additional Information