BIO09066 2016 Bioprocessing Manufacturing Theory

General Details

Full Title
Bioprocessing Manufacturing Theory
Transcript Title
BIOPROCESSING MANUFACTURING
Code
BIO09066
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
10 - 10 Credits
Duration
Semester
Fee
Start Term
2016 - Full Academic Year 2016-17
End Term
9999 - The End of Time
Author(s)
Kieran Tobin, Sharon Barrett, Macdara Bodeker
Programme Membership
SG_SBPRO_M09 201600 Master of Science in Bioprocessing SG_SBPRO_O09 201700 Postgraduate Diploma in Science in Bioprocessing SG_SBPRO_M09 201600 Master of Science in Bioprocessing
Description

This module examines all Bioprocessing aspects, both upstream and downstream, of a typical biopharmaceutical production process. It includes the various design factors that need to be considered for bioprocess design. In line real time monitoring tools including Process Analytical technology (PAT) will be addressed. The primary focus will be on recombinant mammalian cell culture lines with some aspects of microbial cell lines also included.

Learning Outcomes

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

1.

Recognise and analyse the main steps involved in the development of a genetically-modified cell-line designed to express a modern biologic drug product.

2.

Identify and evaluate key factors involved in the design of an upstream bioprocess system including which cell line to choose for a particular processing application.

3.

Evaluate and discuss the various designs of bioreactors available and their key features including relative advantages and disadvantages. Also describe the different modes of bioreactor operation.

4.

Describe the main aspects of bioreactor control and operation including the various instrumentation types involved.

5.

Design an effective and efficient downstream process for a protein capture and purification application.

6.

Anlayse the theory and practice of chromatography for purification applications including the various types available.

7.

Interpret and explain other potential downstream processing technologies such as microfiltration, ultrafiltration, diafiltration, centrifugation, electrophoresis and viral exclusion techniques.

8.

Outline and evaluate the main quality control and analytical techniques required for downstream processing.

Teaching and Learning Strategies

Online live and recorded lectures blended with lecture theatre-based learning. Extra reading of peer reviewed journal articles and reviews will be provided.

Module Assessment Strategies

The assessment approach for this module will be 70% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ’s/SAQ’s/LAQ’s, project assignments, mini research projects, oral presentations, vivas etc. A terminal final exam (30%) will take place at the end of the esemester.

Repeat Assessments

Repeat CA in the form of MCQs/SAQs/LAQs and repeat assignments. A repeat final exam will be made available if necessary.

Indicative Syllabus

The range of upstream bioprocessing topics covered will include some of the following: cell line selection for optimal protein expression; cell banking and product scale-up; key bioreactor design features; media feeding feed systems such as batch, fed-batch, continuous; bioreactor instrumentation and controls.

The range of downstream bioprocessing topics covered will include some of the following:the principles and operation of protein capture steps between upstream and downstream operations; filtration technologies including microfiltration, ultrafiltration, tangential flow filtration, diafiltration; chromatographic techniques including gel filtration, ion-exchange (AEX and CEX), hydrophobic interaction, affinity-based techniques for both primary capture and protein purification; HETP and asymmetry in chromatography; viral exclusion technologies.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
70 %
End of Semester / Year Formal Exam
30 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Continuous Assessment Continuous Assessment Closed Book Exam 30 % OnGoing 1,2,3,4,5,6,7,8,9
2 Report Project Written Report 35 % End of Semester 1,2,3,4,5,6,7,8,9
3 Viva Project Interview 5 % Start of Semester 1,2,3,4,5,6,7,8,9

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final seat script terminal exam Final Exam Closed Book Exam 30 % Week 19 1,2,3,4,5,6,7,8,9
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Not Specified Lecture 3 Weekly 3.00
Independent Learning Not Specified Self Study 10 Weekly 10.00
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Module Resources

Non ISBN Literary Resources

Walsh, Gary., Biopharmaceuticals, Wiley, 2003

Ratledge, Colin and Kristiansen Bjorn, Basic Biotechnology, Cambridge Press, 2001

Shuler, M.L. and Kargi, F., Bioprocess Engineering - Basic Concepts, Prentice-Hall, 2002

URL Resources

none

Other Resources

none

Additional Information

none