BIO08047 2019 FORMULATION FILL FINISH AND DELIVERY OF BIOPHARMACEUTICALS

General Details

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_SBIOP_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
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

  • Aspects of Pre-formulation of relevance to Biopharmaceutical formulation e.g. physicochemical principles that govern protein stability.

 

  • 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 Technology.

Lyophilization 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 Continuous Assessment Open Book Exam 10 % Week 5 1,2,3
2 project and presentation Continuous Assessment Project 50 % End of Term 4
3 mcq Continuous Assessment Open Book Exam 10 % Week 8 1,2,3
4 MCQ/LAQ/SAQ Continuous 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

Required Reading
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