BITC S7012 - Pharmaceutical Biotechnology

Full Title:Pharmaceutical Biotechnology
Module Code:BITC S7012
Credits: 7.5
Valid From:Semester 1 - 2013/14 ( September 2013 )
Module Delivered in 1 programme(s)
Module Description:The aims of this module are to provide an understanding of the applications, problems and uses of microorganisms in the pharmaceutical industry and to allow students the opportunity to acquire laboratory skills in the manipulation of industrially significant microbes and their products.
Learning Outcomes:
On successful completion of this module the learner should be able to
  1. Explain how micro-organisms and mammalian cells can be cultured on a large scale.
  2. Identify and differentiate between different expression systems for the production of biopharmaceuticals.
  3. Discuss bioprocessing and pharmaceutical products of microbial origin.
  4. Recognise microbial contamination and choose appropriate testing measures to avoid contamination in the pharmaceutical industry.

Module Content & Assessment

Indicative Content
Review of the structure, growth and metabolism of microbial cells. Beneficial use of microorganisms in industry. Properties of an Industrial Microorganism. Factors affecting the growth of Industrial Microorganisms.
Fermentation Technology
Modes of fermentation, reactor types, process control, scale-up.
Upstream Processing
A review of recombinant product generation. Recombinant E. coli and other recombinant prokaryotic systems. Yeast and fungal cell culture systems. Insect cells as expression systems. Recombinant animal cell lines and hybridoma cell lines. Transgenic plants and animals.
Downstream Processing
Cell harvesting, cell disruption, product recovery and protein purification.
Microbial contamination in the Pharmaceutical Industry
Microbial contamination in the pharmaceutical industry. Endotoxin and pyrogen detection and identification. Approaches to avoiding contamination, focus on sterilisation and cleanrooms.
Production of Pharmaceutical products
Selected Case studies: Production of antibiotics, vaccines and therapeutic enzymes.
Sample practical exercises
Yeast fermentation, GFP purification, Antibiotic production, Endotoxin testing, Industrial visits
Assessment Breakdown%
Course Work10.00%
End of Module Formal Examination50.00%

Full Time

Course Work
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Short Answer Questions There will be a 1-hour short question written examination half-way through the semester, the student will be required to answer 20 out of 20 questions. 1,2 10.00 0 0 Week 8 0
No Project
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Practical/Skills Evaluation A 3-hour practical session each week will provide the student with the opportunity to back up the theory covered in formal lectures with practical experience. Students must submit a written report of a professional standard on each laboratory session. 3,4 40.00 0 0 n/a 0
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Formal Exam End-of-Semester Final Examination 1,2,3,4 50.00 0 0 End-of-Semester 0

DKIT reserves the right to alter the nature and timings of assessment


Module Workload & Resources

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture 4 x 1 hour interactive lectures per week. 4.00 Every Week 4.00
Practical 1 x 3 hour practical per week. 3.00 Every Week 3.00
Independent Study Self / group study 3.00 Every Week 3.00
Directed Reading Notes / Paper / Textbook reading 1.00 Every Week 1.00
Total Weekly Learner Workload 11.00
Total Weekly Contact Hours 7.00
This course has no Part Time workload.
Recommended Book Resources
  • S. Denyer, N.A. Hodges and S.P. Gorman 2011, Hugo and Russell’s Pharmaceutical Microbiology, 8th Ed., Wiley-Blackwell
  • M. Waites, N.L. Morgan, J.S. Rockey and G. Higton 2009, Industrial Microbiology, Wiley-Blackwell (available on DkIT Dawsonera online collection)
  • G. Walsh 2003, Biopharmaceuticals: Biochemistry and biotechnology, 2nd Ed., Wiley
  • J.E. Smith 2009, Biotechnology, 5th Ed., Cambridge University Press
  • N.J. Hoboken 2007, Handbook of pharmaceutical biotechnology, Wiley-Interscience
Supplementary Book Resources
  • Madigan et al. 2011, Brock Biology of Microorganisms, 13th Ed., Pearson education
  • L.M. Prescott 2005, Microbiology, McGraw-Hill
Recommended Article/Paper Resources
  • A. Demain 2000, Small bugs, big business: The economic power of the microbe, Biotechnology Advances, 18, 499-514
  • N. Ferrer-Miralles, J. Domingo-Espin, J.L. Corchero, E. Vazquez, A. Villaverde 2009, Microbial factories for recombinant pharmaceuticals, Microbial Cell Factories, 8 (17), 1-8
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
DK_SPHAR_7 Bachelor of Science in Pharmaceutical Science 5 Mandatory