BIO08056 2020 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
BIO08056
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
10 - 10 Credits
Duration
Semester
Fee
Start Term
2020 - Full Academic Year 2020-21
End Term
9999 - The End of Time
Author(s)
Stephen Daly, Kevin Colonna
Programme Membership
SG_SBIOM_H08 202000 Bachelor of Science (Honours) in Biomedical and BioIndustrial Sciences
Description

This module provides students with an in-depth understanding formulation and fill finish of a biopharmaceutical and also addresses current and emerging drug delivery systems.

This module is designed to develop an in-depth understanding of the formulation and fill finish of a biopharmaceutical.

AIMS

To provide students with an in-depth understanding of major considerations in the formulation and fill finish of a biopharmaceutical also addressing current and emerging drug delivery systems with relevant professional applications in biomedical sciences.

Learning Outcomes

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

1.

Critically discuss the 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.

Perform research and a series of laboratory experiments relating to formulation/fill-finish, and then analyse, evaluate, draw reasoned conclusions and generate a report.

Teaching and Learning Strategies

This module is taught by lectures supported by self-directed reading material, and project assignments involving laboratory practical work. A range of Computer-Aided Learning (CAL) packages are also used to support this module. Students are provided with electronic materials for self-assessment and preparation for examinations. Self-directed, student- centred, independent learning is also encouraged through completion of module coursework. The laboratory practical work will be carried out at National Institute for Bioprocessing Research and Training (NIBRT), Blackrock over 3 days.

Module Assessment Strategies

Class Test [50%]

Includes short form assessment exams MCQ/short answer questions and problems and longer essay based assignment. This will be 5 assessments, worth 25% each.

 

Project [50%]

A project/lab. practical will be undertaken over the course of the module and the outcomes will be assessed as a written report (2000 words for 40% of module marks) together with a project presentation (10 minutes for 10% of module marks) at the end of the module.

 

Feedback: Students will be provided with the assessment criteria for each assignment. Feedback will be written and detailed against each criteria as appropriate. Further information and guidelines on assignments, assessment criteria and submission schedule is provided in the module handout.

 

100% Coursework                                                                                0% Examination

Repeat Assessments

N/A

Indicative Syllabus

This module will blend lecture material with applied content that includes the following: 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. 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 Class Test Coursework Assessment Assessment 50 % OnGoing 1,2,3,4
2 Project Project Project 50 % OnGoing 1,2,3,4
             

Online Learning Mode Workload


Type Location Description Hours Frequency Avg Workload
Supervision Offsite Facility Practicals 24 Once Per Module 1.60
Online Lecture Online Lectures 2 Weekly 2.00
Total Online Learning Average Weekly Learner Contact Time 3.60 Hours

Module Resources

Non ISBN Literary Resources

Required:

Banga, A. K. (2015) Therapeutic Peptides and Proteins. Formulation, Processing, and Delivery Systems (3rd edition). Boca Raton, CRC Press.

Mc Nally, E.J. and Hastedt, J.E. (Editors) (2007) Protein Formulation and Delivery (2nd edition). London, Informa Healthcare.

Recommended:

Students will also be directed to online resources as required, including relevant up-to-date scientific literature, and to other relevant reading material during teaching sessions and via the online module materials.