BIO08047 2019 FORMULATION FILL FINISH AND DELIVERY OF BIOPHARMACEUTICALS
Full Title
FORMULATION FILL FINISH AND DELIVERY OF BIOPHARMACEUTICALS
Transcript Title
FORMULATION FILL FINISH AND DE
Code
BIO08047
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Kieran Tobin, Mary Butler
Programme Membership
SG_SBIOP_E08 201900 Level 8 Certificate in Science in Biopharmaceutical Science
SG_SBIOT_E08 201900 Certificate in Science in Bioprocessing Technologies SG_SBIOT_E08
SG_SBIOP_K08 201900 Bachelor of Science (Honours) in Biopharmaceutical Science.
SG_SCOLI_E08 201900 Certificate in Science in Colin McLeans Test Programme
SG_SBIOT_E08 202200 Certificate in Bioprocessing Technologies SG_SBIOT_E08
SG_SBIOP_K08 202200 Bachelor of Science (Honours) in Biopharmaceutical Science (Add-on)
Description
This module aims to provide students with an understanding of the main considerations in the formulation and fill finish of a biopharmaceutical.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Describe protein structure and what contributes to protein destabilisation.
2.
Describe what excipients are added to a protein formulation and why they are added.
3.
Explain the principles and applications of typical fill-finish and freeze-drying technologies.
4.
Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.
Teaching and Learning Strategies
as above
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 including multiple choice and short answer questions/problems, project assignments/reports, essays and oral presentations.
The mini-project is a MANDATORY form of assessment for any modules on this programme with a mini-project component.
Repeat Assessments
as per Q manual
Indicative Syllabus
Dosage forms: Liquid, Frozen liquid, Solid Lyophilized (freeze-dried) etc Main types of excipients (stabilizers) used in biopharmaceutical formulation. Packaging materials for biopharmaceuticals.
Fill/Finish Technology. |
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Continuous Assessment May take the form of MCQ | Coursework Assessment | Open Book Exam | 10 % | Week 5 | 1,2,3 |
| 2 | project and presentation | Coursework Assessment | Project | 50 % | End of Term | 4 |
| 3 | mcq | Coursework Assessment | Open Book Exam | 10 % | Week 8 | 1,2,3 |
| 4 | MCQ/LAQ/SAQ | Coursework Assessment | Closed Book Exam | 40 % | Week 12 | 1,2,3 |
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Distance Learning Suite | Lecture | 2 | Weekly | 2.00 |
| Independent Learning | Not Specified | Self-directed learning and continuous assessment | 70 | Once Per Semester | 4.67 |
Total Part Time Average Weekly Learner Contact Time 2.00 Hours
Required & Recommended Book List
Required Reading
20/08/2019 Protein Formulation and Delivery Informa Health Care, New York
20/08/2019 Protein Formulation and Delivery Informa Health Care, New York
Required Reading
20/06/2019 Therapeutic Peptides and Proteins. Formulation, Processing, and Delivery Systems Taylor and Francis
20/06/2019 Therapeutic Peptides and Proteins. Formulation, Processing, and Delivery Systems Taylor and Francis
Module Resources
Non ISBN Literary Resources
Protein Formulation and Delivery by E. J. Mc Nally. Publisher; Informa Health Care, New York. Year 2008.
Therapeutic Peptides and Proteins. Formulation, Processing, and Delivery Systems by A. K. Banga. Second Edition. Publisher Taylor and Francis. Year 2006.
Journal Resources
as above
URL Resources
as per moodle page
Other Resources
|
Various reading sources will be either provided or recommended by the module tutor. |
Additional Information
None