BIO09063 2016 Bioprocessing Manufacturing Laboratories
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.
On completion of this module the learner will/should be able to;
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.
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.
Interpret and critically evaluate the data and results obtained from the various bioprocessing practicals.
Take responsibility for and direct the work of other individuals in a quasi-GMP environment.
Demonstrate research skill and capabilities in the overall bioprocessing area.
Evaluate ongoing education and training needs in a continuous professional development environment.
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 (on line) where necessary
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
|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
|Independent Learning||Not Specified||Report||8||Weekly||8.00|
|Laboratory Practical||Science Laboratory||Laboratory||37.5||Once Per Semester||2.50|
Doran, Pauline M. 'Bioprocess Engineering Principles'. Academic Press. 1995.
Ratledge, Colin and Kristiansen Bjorn. 'Basic Biotechnology'. Cambridge Press. 2001.
Walsh, Gary. 'Biopharmaceuticals'. Wiley. 2003.