BIO09063 2016 Bioprocessing Manufacturing Laboratories

General Details

Full Title
Bioprocessing Manufacturing Laboratories
Transcript Title
Bioprocessing Manufacturing Labs.
Code
BIO09063
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 addresses the practical knowledge, know-how and skills associated with the bioprocessing, both upstream and downstream, of modern biologic drug products. The relevant learning is acquired through the completion of a sequence of laboratory-based and pilot-plant based practicals and experiments that are designed to impart the required knowledge, know-how and skills.

Learning Outcomes

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

1.

Demonstrate a range of practical know-how and skills associated with relevant, lab-based and pilot plant-based upstream bioprocessing equipment for the Biopharmaceutical Processing industry.

2.

Demonstrate a range of knowledge and skill in standard and specialised techniques in downstream protein capture and purification at both lab. and pilot plant scale of operation.

3.

Interpret and critically evaluate the data and results obtained from the various bioprocessing practicals.

4.

Take responsibility for and direct the work of other individuals in a quasi-GMP environment.

5.

Demonstrate research skill and capabilities in the overall bioprocessing area.

6.

Evaluate ongoing education and training needs in a continuous professional development environment.

7.

Demonstrate effective communication skills both orally and in writing.

Teaching and Learning Strategies

Labs will be performed over a series of workshop days at NIBRT

Lectures will be blended (both on line [live and recorded] and lecture theatre-based

Module Assessment Strategies

See module assessment attached

Repeat Assessments

Repeat assessments (on line) where necessary

Module Dependencies

Prerequisites
Bioprocessing Manufacturing Theory module.

Indicative Syllabus

The range of lab-based practicals covered will include some of the following items: aseptic techniques; cell culture techniques including cell counting (both manual and automated); sub-culturing including media exchange; benchtop bioreactor techniques such as disassembly/reassembly of parts; sampling and substrate analysis; filter integrity testing; centrifugation for cell separation purposes; specific chromatography practicals based around different chromatography columns; protein concentration and buffer exchange using ultrafiltration / diafiltration; normalised water flow permeability (NWP) test of a filter.

The range of pilot-plant based practicals covered will include some of the following items: SIP cycle operation and analysis on bioreactor systems; operation of single-use bioreactor technologies; operation of the disc-stack centrifuge separation system; filter integrity testing; theory and practice of industrial-scale chromatography skids; column packing and analysis;theory and practice of industrial-scale ultrafiltration / diafiltration skids.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Pre-lab. Assessment of assigned work Practical Project 25 % Any 1,2,3,4
2 Open Book Exam End of practical assessment exams. Continuous Assessment Open Book Exam 25 % Any 1,2,3,4
3 Written Report on lab. practical work completed including external minor research. Project Assignment 50 % Any 1,2,3,4,5,6,7

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Not Specified Lecture 1 Fortnightly 0.50
Independent Learning Not Specified Report 8 Weekly 8.00
Laboratory Practical Science Laboratory Laboratory 37.5 Once Per Semester 2.50
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Module Resources

Non ISBN Literary Resources

Doran, Pauline M. 'Bioprocess Engineering Principles'. Academic Press. 1995.

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

Walsh, Gary. 'Biopharmaceuticals'. Wiley. 2003.

URL Resources

None

Other Resources

None

Additional Information

None