BIO07013 2019 Formulation and Fill-Finish.
Full Title
Formulation and Fill-Finish.
Transcript Title
Formulation and Fill-Finish.
Code
BIO07013
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Paul Walsh, Mary Butler
Programme Membership
SG_SBIOP_J07 201900 Bachelor of Science in Biopharmaceutical Science (Add-on)
SG_SBIOP_E07 201900 Certificate in Biopharmaceutical Processing
Description
This module aims to provide students with an understanding of the main considerations in the formulation and fill finish of a biopharmaceutical drug.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Describe the key principles of aseptic processing as they relate to drug fill-finish operations.
2.
Compare and contrast routes of delivery for biopharmaceuticals (e.g. pulmonary, parenteral, transdermal).
3.
Describe the main filling and closure technologies and their control and operation.
4.
Explain the principles and applications of freeze-drying technology.
5.
Outline the typical quality control measures required for a fill-finish operation.
Teaching and Learning Strategies
N/A
Module Assessment Strategies
A combination of continuous assessment strategies, some laboratory experiments and an end-of-term exam.
Repeat Assessments
N/A
Indicative Syllabus
Aspects of preformulation of relevance to Biopharmaceutical formulation e.g. physicochemical principles that govern stability.
Routes of Administration: Parenteral, Oral, Pulmonary, Nasal, Transdermal etc
Formulation:
- 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 Technologies.
Lyophilization Technologies.
Quality Control and batch release criteria for fill-finish operations.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Continuous Assessment Short-form exams and assessments. | Coursework Assessment | Assessment | 25 % | Week 6 | 1,2,3,4,5 |
| 2 | Multiple Choice Quiz | Coursework Assessment | Assessment | 25 % | Week 12 | 1,2,3,4,5 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Final Exam | Final Exam | Closed Book Exam | 50 % | End of Term | 1,2,3,4,5 |
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Distance Learning Suite | Online lecture. | 1 | Weekly | 1.00 |
| Directed Learning | Not Specified | Directed self-study. | 4 | Weekly | 4.00 |
Total Part Time Average Weekly Learner Contact Time 5.00 Hours
Module Resources
Non ISBN Literary Resources
Pharmaceutical Biotechnology: An Introduction for Pharmacists and Pharmaceutical Scientists, 2nd Edition. J. Daan and R. Sindelar. Publisher: Taylor and Francis. ISBN: 0415285003.
Pharmaceutics: The Science of Dosage Form Design (2nd edn). Aulton ME. Churchill. Livingston, 2002.
Journal Resources
N/A
URL Resources
N/A
Other Resources
None
Additional Information
None