BIO08018 2011 FORMULATION FILL FINISH AND DELIVERY OF BIOPHARMACEUTICALS

General Details

Full Title
FORMULATION FILL FINISH AND DELIVERY OF BIOPHARMACEUTICALS
Transcript Title
Formulation of Biologics
Code
BIO08018
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
2011 - Full Academic Year 2011-12
End Term
2014 - Full Academic Year 2014-15
Author(s)
Kieran Tobin, Sharon Barrett
Programme Membership
SG_SBIOP_K08 201100 Bachelor of Science (Honours) in Biopharmaceutical Science. SG_SBIOP_E08 201100 Level 8 Certificate in Science in Biopharmaceutical Science SG_SBIOP_E08 201100 Level 8 Certificate in Science in Biopharmaceutical Science SG_SBIOP_E08 201100 Level 8 Certificate in Science in Biopharmaceutical Science SG_SBIOT_E08 201500 Certificate in Science in Bioprocessing Technologies SG_SBIOT_E08
Description

This module aims to provide students with an understanding of the main considerations in the formulation and fill finish of a biopharmaceutical and also addresses current and emerging drug delivery systems.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Formulate and communicate judgements with regard to challenges in the formulation of biopharmaceuticals.

2.

Compare routes of delivery for biopharmaceuticals (e.g. pulmonary, parenteral, transdermal) and evaluate current and novel drug delivery systems designed for biopharmaceuticals.

3.

Explain the principles and applications of typical fill-finish and freeze-drying technologies.

4.

Analyse, evaluate and draw conclusions from data presented in problem solving exercises.

5.

Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.

6.

Communicate scientific data in an appropriate format on this topic.

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.

Indicative Syllabus

Aspects of Preformulation of relevance to Biopharmaceutical formulation e.g. physicochemical principles that govern protein stability.

Formulation:

  1. Dosage forms: Liquid, Frozen liquid, Solid Lyophilized (freeze-dried) etc
  2. Main types of excipients (stabilizers) used in biopharmaceutical formulation.
  3. Packaging materials for biopharmaceuticals.

Fill/Finish Technology.

Lyophilization Technology.

Routes of Administration: Parenteral, Oral, Pulmonary, Nasal, Transdermal etc

Drug Delivery: Controlled release, Targeted delivery and Specialised delivery systems e.g. liposomes, nanoparticles, microparticles.

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/SAQ or essay type assessment Continuous Assessment UNKNOWN 50 % OnGoing 1,2,3,4
2 Project Project and Presentation Continuous Assessment UNKNOWN 50 % End of Term 5,6
             

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

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.

Other Resources

Various reading sources will be either provided or recommended by the module tutor.

Additional Information

None