BIO09094 2021 Biologics Manufacturing: Current and Future
Full Title
Biologics Manufacturing: Current and Future
Transcript Title
Biologics Manufacturing: Curre
Code
BIO09094
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2021 - Full Academic Year 2021-22
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SBIOI_E09 202100 Postgraduate Certificate in BioIndustry 4.0
SG_SVALI_O09 202300 Postgraduate Diploma in Science in Validation and Digitalisation Technologies
SG_SVALI_M09 202300 Master of Science in Validation and Digitalisation Technologies
SG_SBIOI_M09 202300 Master of Science in BioIndustry 4.0
Description
This module aims to provide students with a detailed knowledge and understanding of the future needs of the biopharmaceutical sector beyond Industry 4.0, and includes approaches such as continuous manufacturing, single-use optimization, modular facility design; ATMPs, Cell & Gene therapy; Novel technologies.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Demonstrate a detailed knowledge of current manufacturing processes for upstream, downstream and fill finish operations.
2.
Evaluate novel technologies in upstream and downstream to implement continuous and intensified processes.
3.
Demonstrate an understanding of Advanced Therapy Medicinal Products (ATMPs), including biomedical science, molecular basis of disease, stem cell biology and tissue repair, and clinical applications for ATMP
4.
Integrate knowledge and formulate judgements on ATMP manufacturing challenges, current and developing technologies, and quality control / quality affairs.
Teaching and Learning Strategies
This module will be taught using on‑line lectures. A range of Computer‑Aided Learning (CAL) packages are also used to support this module (e.g. Moodle,Adobe Connect, Panopto, Camtasia). Students are provided with electronic materials for self‑assessment and preparation for assessments/assignments. 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 employed including some of the following: Enquiry based Projects, Assignments/mini projects including Viva/Presentation Short-form assessment exams incl. MCQs, Short answer and Long Answer Questions.
Repeat Assessments
Students will have opportunities to re-submit work as agreed with their lecturer.
Indicative Syllabus
The following is a summary of the main topics included in this module: upstream, downstream and fill finish manufacturing operations, continuous manufacturing processes, single-use optimization, ATMP manufacture, Cell & Gene therapy, novel technologies for upstream and downstream operations.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | MCQ 2 | Coursework Assessment | Multiple Choice/Short Answer Test | 20 % | Week 7 | 1,2,3 |
| 2 | End of Semester Assessment | Coursework Assessment | Assignment | 30 % | Week 10 | 1,2,3,4 |
| 3 | Project & Viva | Project | Project | 50 % | Week 12 | 1,2,3,4 |
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Online | Lecture | 2 | Weekly | 2.00 |
| Independent Learning | Not Specified | Self Study | 5 | Weekly | 5.00 |
Total Part Time Average Weekly Learner Contact Time 2.00 Hours
Required & Recommended Book List
Required Reading
2014-05-12 Proteins John Wiley & Sons
ISBN 9780470669853 ISBN-13 0470669853
2014-05-12 Proteins John Wiley & Sons
ISBN 9780470669853 ISBN-13 0470669853
Proteins Biochemistry and Biotechnology 2e is a definitive source of information for all those interested in protein science, and particularly the commercial production and isolation of specific proteins, and their subsequent utilization for applied purposes in industry and medicine. Fully updated throughout with new or fundamentally revised sections on proteomics as, bioinformatics, protein glycosylation and engineering, well as sections detailing advances in upstream processing and newer protein applications such as enzyme-based biofuel production this new edition has an increased focus on biochemistry to ensure the balance between biochemisty and biotechnology, enhanced with numerous case studies. This second edition is an invaluable text for undergraduates of biochemistry and biotechnology but will also be relevant to students of microbiology, molecular biology, bioinformatics and any branch of the biomedical sciences who require a broad overview of the various medical, diagnostic and industrial uses of proteins. Provides a comprehensive overview of all aspects of protein biochemisty and protein biotechnology Includes numerous case studies Increased focus on protein biochemistry to ensure balance between biochemisty and biotechnology Includes new section focusing on proteomics as well as sections detailing protein function and enzyme-based biofuel production "With the potential of a standard reference source on the topic, any molecular biotechnologist will profit greatly from having this excellent book. " (Engineering in Life Sciences, 2004; Vol 5; No. 5) Few texts would be considered competitors, and none compare favorably." (Biochemistry and Molecular Education, July/August 2002) "...The book is well written, making it informative and easy to read..." (The Biochemist, June 2002)
Module Resources
Non ISBN Literary Resources
Journal Resources
URL Resources
Alliance for Regenerative Medicine Annual Report. 2021
BioPhorum Operations Group: Biomanufacturing Technology Roadmap.
Abhinav A. Shukla, Brian Hubbard, Tim Tressel, Sam Guhan, Duncan Low (2007) Downstream processing of monoclonal antibodies—Application of platform approaches
Deloitte: Advanced Biopharmaceutical Manufacturing: An Evolution Underway. (2015)
Adriana G. Lopes (2015) Single-use in the biopharmaceutical industry: A review of current technology impact, challenges, and limitations.
David A. Wolton and Andy Rayner (2014) Lessons Learned in the Ballroom, Pharmaceutical Engineering
David AR Wolton Treasa Rohrer (2020) Biopharma Facility Design: Lessons Learned on the Dance Floor, Pharmaceutical Engineering (online exclusive at www.ispe.org)
Other Resources
None
Additional Information