SCI09009 2023 Molecular Engineering
This module is taken by Level 9 students enrolled in the Advanced Therapy Medicinal Products (ATMPs) course. It aims to provide student with an understanding of how molecular engineering has framed the biopharmaceutical industry’s approach to the design of ATMP’s both currently on the market and in the clinical trial pipeline. This module will provide students with the necessary skills and tools to understating how ATMP’s are engineered to be an effective therapeutic on a molecular and protein level, and the potential of emerging innovations in this field.
Learning Outcomes
On completion of this module the learner will/should be able to;
Detail the desired molecular characteristics of ATMPs and how this impacts the therapeutic potential of the product and how these characteristics are engineered into the process.
Evaluate the technology used in the development and manufacture of ATMPs that have achieved regulatory approval and are currently on the market.
Review emerging molecular engineering technologies that are currently undergoing research and development in the design of novel ATMPs.
Critique the role molecular engineering and design have in the ATMPs currently undergoing clinical trials and discuss the challenges they possess in gaining regulatory approval.
Construct molecular engineering approaches that may be utilized in the future generation of 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. 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. Detail knowledge and understanding of desired molecular characteristics of ATMPs and how this impacts the therapeutic potential of the product and how these characteristics are engineered into the process.
- Intro to Molecular Engineering, Molecular engineering techniques – DNA, RNA, nucleic acid biology, cloning, sequencing etc, Intro to Protein Engineering, Rational and Directed Evolution as methods of Protein Engineering,
2. Evaluate the technology used in the development and manufacture of ATMPs that have achieved regulatory approval and are currently on the market.
- Cell Line generation – Viral Vector Production/Allogenic Cell Therapies, Cell Therapy – Designing CART, Immunotherapies
3. Review emerging molecular engineering technologies that are currently undergoing research and development in the design of novel ATMPs.
- How to use CRISPR to design genes, How to design genes for effective delivery for Gene Therapy, How to target specific genes for Gene Therapy, DC based Vaccines.
4. Critique the role molecular engineering and design have in the ATMPs currently undergoing clinical trials and discuss the challenges they possess in gaining regulatory approval.
- Current clinical trial case studies and review
5. Construct molecular engineering approaches that may be utilized in the future generation of ATMPs.
- New and emerging technologies
Coursework & Assessment Breakdown
Coursework Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Quiz | Coursework Assessment | Multiple Choice/Short Answer Test | 20 % | Week 5 | 1,2 |
2 | Report | Coursework Assessment | Assignment | 30 % | Week 9 | 3,4 |
3 | Group work | Project | Group Project | 50 % | Week 13 | 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 |
Required & Recommended Book List
2008 Molecular Cell Biology Macmillan
ISBN 0716776014 ISBN-13 9780716776017
The sixth edition provides an authoritative and comprehensive vision of molecular biology today. It presents developments in cell birth, lineage and death, expanded coverage of signaling systems and of metabolism and movement of lipids.
Module Resources
Boglioli E, Richard M. "Rewriting the book of life: a new era in precision genome editing" (PDF). Boston Consulting Group. Retrieved February 14, 2023.
Barrangou R, Doudna JA (September 2016). "Applications of CRISPR technologies in research and beyond". Nature Biotechnology. 34 (9): 933–941.
Kim H, Kim JS (May 2014). "A guide to genome engineering with programmable nucleases". Nature Reviews. Genetics. 15 (5): 321–34.
Xie M, Viviani M, Fussenegger M. Engineering precision therapies: lessons and motivations from the clinic. Synth Biol (Oxf). 2020 Nov 24;6(1):ysaa024. doi: 10.1093/synbio/ysaa024. PMID: 33817342; PMCID: PMC7998714.
Ruppel KE, Fricke S, Köhl U, Schmiedel D. Taking Lessons from CAR-T Cells and Going Beyond: Tailoring Design and Signaling for CAR-NK Cells in Cancer Therapy. Front Immunol. 2022 Mar 18;13:822298. doi: 10.3389/fimmu.2022.822298. PMID: 35371071; PMCID: PMC8971283.
Kloess S, Kretschmer A, Stahl L, Fricke S, Koehl U. CAR-Expressing Natural Killer Cells for Cancer Retargeting. Transfus Med Hemother. 2019 Feb;46(1):4-13. doi: 10.1159/000495771. Epub 2019 Feb 5. PMID: 31244577; PMCID: PMC6558329.