BIO08051 2016 Formulation Fill Finish and Delivery of Biopharmaceuticals

General Details

Full Title
Formulation Fill Finish and Delivery of Biopharmaceuticals
Transcript Title
Form Fill Finish
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
LIFE - Life Sciences
08 - NFQ Level 8
10 - 10 Credits
Start Term
2016 - Full Academic Year 2016-17
End Term
9999 - The End of Time
Stephen Daly

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;


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



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


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


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


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


Communicate scientific data in an appropriate format on this topic.


Understand the practical considerations involved in typical fill-finsh operations

Teaching and Learning Strategies


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. A practical element of this course is also included as part of training in NIBRT.

The miniproject is a MANDATORY form of assessment for any modules on this programme with a miniproject component.

Repeat Assessments

Dependent on the failed element that needs to be repeated.

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.

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 Continuous Assessment Assignment 50 % OnGoing 1,2,3,4
2 Project Presentation Practical Project 30 % End of Term 5,6
3 Practical Training NIBRT Practical Practical Evaluation 20 % Week 8 3,4,7

Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Workload
Online Lecture Distance Learning Suite Lecture 2 Weekly 2.00
Independent Learning Offsite Independent Learning 70 Once Per Semester 4.67
Practical Science Laboratory Laboratory Practicals 8 Once Per Module 0.53
Total Distance Learning Average Weekly Learner Contact Time 2.53 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.