SCI09017 2023 Viral and Non Viral vector Production Systems
Full Title
Viral and Non Viral vector Production Systems
Transcript Title
Vector Production Systems
Code
SCI09017
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)
Macdara Bodeker, Rachel Coyle, Ailish Breen
Programme Membership
SG_SATMP_S09 202300 Postgraduate Certificate in Advanced Therapy Medicinal Products (ATMP) Vector Manufacturing
SG_SATMQ_M09 202300 Master of Science in Advanced Therapy Medicinal Products (ATMP) Vector Manufacturing
SG_SATMP_O09 202300 Postgraduate Diploma in Science in Advanced Therapy Medicinal Products (ATMP) Technology and Manufacturing
SG_SATMP_M09 202300 Master of Science in Advanced Therapy Medicinal Products (ATMP) Technology and Manufacturing
Description
This module is to be taken by Level 9 students enrolled on the Certificate in ATMP Vector Manufacturing / MSC in ATMP Technology and Manufacturing or the MSc in ATMP Manufacturing Development (60 credit thesis). It aims to provide students with the background in vector production, both viral and non-viral means. The biology, current and future vector systems will be covered to give students and overall understanding of the uses and importance of vector use for clinical outcomes. The course also focusses on the manufacturing and production process of vectors to ensure students have a complete understanding of the methods and reasons behind the challenges and steps required to supply demand.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Describe vector biology of common vector systems and differentiate between different vector systems for different applications.
2.
Describe and evaluate the manufacturing, purification and formulation processes for viral vectors.
3.
Examine existing and emerging non viral vector systems and describe manufacturing methods associated with these.
4.
Evaluate manufacturing optimisation processes and critique new and emerging technologies
5.
Propose relevant QC analytical test methods for different stages of vector production
Teaching and Learning Strategies
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.
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. Assignment work may involve structured analyses of current literature to identify cutting edge technologies and identify gaps in knowledge.
Repeat Assessments
Repeat continuous assessment of the failed elements in line with marks and standards
Indicative Syllabus
1. Describe vector biology of common vector systems and differentiate between different vector systems for different applications, including clinical applications.
- Vector biology
- AAV, adenovirus, lentivirus, retrovirus and other virus’ of relevance.
2. Describe and evaluate the manufacturing, purification and formulation processes for viral vectors. Upstream Processing of plasmids for viral vectors (fermentation, recovery)
- Plasmids for viral vectors, producer cell lines
- Downstream processing for plasmids for viral vectors (purification, formulation)
- Manufacturing and purification of viral systems (Adenovirus, AAV, retrovirus, lentivirus), Formulation and administration
3. Examine existing and emerging non viral vector systems and describe manufacturing methods associated with these.
- Non-viral systems (physical and chemical methods plasmid systems, polymer, lipid, peptide, inorganic material, hybrid systems, emerging systems)
4. Evaluate manufacturing optimisation processes and critique new and emerging technologies
- Vector design, product risks and impurities, critical quality attributes
5. Propose relevant QC analytical test methods for different stages of vector production
- QC analytics and associated test methods (identity, purity, sterility etc.)
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | MCQ/SAQ/LAQ | Coursework Assessment | Assessment | 15 % | Week 5 | 1,2 |
| 2 | Group work case study | Coursework Assessment | Assessment | 35 % | Week 9 | 2,3 |
| 3 | Assignment and presentation | Coursework Assessment | Assignment | 50 % | End of Semester | 4,5 |
Online Learning Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Online | Lecture | 2 | Weekly | 2.00 |
| Independent Learning | Not Specified | Directed and self directed learning | 4 | Weekly | 4.00 |
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours
Module Resources
Non ISBN Literary Resources
D. M. F. Prazeres, J. A. L. Santos. Production and Purification of Adenovirus Vectors for Gene Therapy. Pharmaceutical Development Series. March 2010:1-36. doi:10.1002/9780470571224.pse329
Crespo-Barreda A, Encabo-Berzosa MM, González-Pastor R, et al. Chapter 11 - Viral and Nonviral Vectors for In Vivo and Ex Vivo Gene Therapies. Translating Regenerative Medicine to the Clinic. January 2016:155-177. doi:10.1016/B978-0-12-800548-4.00011-5
Valeria Severino. Tools and Applications in Gene Therapy. Delve Publishing; 2019. Accessed March 16, 2023. https://search.ebscohost.com/login.aspx?direct=true&AuthType=ip,sso&db=nlebk&AN=2014055&site=eds-live&scope=site
Updated Literary Resources
Journal Resources
Myriam Sainz-Ramos, Idoia Gallego, Ilia Villate-Beitia, et al. How Far Are Non-Viral Vectors to Come of Age and Reach Clinical Translation in Gene Therapy International Journal of Molecular Sciences. 2021;22(7545):7545. doi:10.3390/ijms22147545
Singh N, Heldt CL. Challenges in downstream purification of gene therapy viral vectors. Current Opinion in Chemical Engineering. 2022;35:N.PAG. doi:10.1016/j.coche.2021.100780
Selvaraj N, Wang C-K, Bowser B, et al. Detailed Protocol for the Novel and Scalable Viral Vector Upstream Process for AAV Gene Therapy Manufacturing. Human Gene Therapy. 2021;32(15/16):850-861. doi:10.1089/hum.2020.054
URL Resources
Other Resources
Additional Information