Full Title:Biopharmaceutical Analysis
Module Code:PHAR S8010
Credits: 7.5
Valid From:Semester 1 - 2015/16 ( September 2015 )
Module Delivered in 1 programme(s)
Module Description:The aims of this module are to provide students with a detailed understanding of a range of specialised investigational techniques and their application areas and associated problems within the biopharmaceutical and related industries.
Learning Outcomes:
On successful completion of this module the learner should be able to
  1. Assess the principles and applications of, and the instrumentation used for, advanced aspects of modern analytical techniques such as high performance liquid chromatography (HPLC), gas chromatography and mass spectrometry.
  2. Perform High Performance Liquid Chromatography, Gas Chromatography and Capillary Eectrophoresis in the laboratory.
  3. Demonstrate how chromatographic systems and separations can be numerically evaluated and hence how they can be used to identify sample materials and determine concentrations by reference to the performance of standards.
  4. Compare and contrast specialised techniques such as capillary electrophoresis, ELISA, Western Blot analysis, SDS-PAGE and 2D SDS-PAGE.
  5. Evaluate and assess the application areas and associated limitations of the above techniques within the spectrum of biopharmaceutical sciences (raw material, intermediate product and end-product).

Module Content & Assessment

Indicative Content
HPLC, Gas Chromatography, Mass Spectrometry
• HPLC - Principle. Instrumentation (columns, mobile phase, stationary Phase). Detectors (UV , Fixed Wavelength, Multi-wavelength , Diode Array, Electrical Conductivity, Fluorescence, Refractive Index, Tridet Multi Functional). Applications. Separation Modes (Reverse Phase HPLC, Hydrophilic Interaction , Ion Exchange, Size Exclusion, Immobilised Metal Affinity, Chiral). • Gas Chromatography - Principle. Instrumentation (injectors, columns, mobile Phase, stationary phase). Detectors (FID, Nitrogen-Phosphorus, Electron Capture, Katherometer). Sample preparation (derivatisation). Applications. • Mass Spectrometry - Principle. Instrumentation - Ion source (Electrospray, MALDI). Analyser (TOF, Quadropole, Ion Trap, Fourier Transform, Electromagnetic, Hybrid Mass Spectrometers). Applications. Analyisis of Mass Spectra.
Numerical evaluation of chromatographical systems.
Qualitative versus quantitative analysis. Measures of Chromatographic Performance: Distribution/Partition Coefficient (KD); Retention – Time and Volume; Retention Factor/Capacity Factor; Selectivity Factor; Plate Theory & Column Efficiency; Resolution; Rate Theory (Van Deemter Equation). Calculation of concentration and purity by direct proportion and using internal and exteral standards.
Capillary Electrophoresis, ELISA, Western blot, SDS-PAGE and 2D SDS-PAGE.
• Capillary Electrophoresis - Principle. Intrumentation (sample injection, capillary columns, detectors - UV, laser induced fluorescent detector). Applications. Separation modes (Capillary Zone Electrophoresis (CZE), Micellar Electrokinetic Chromatography (MEKC), Capillary Isoelectric Focusing (CEF), Capillary Isotachophoresis (CITP), Capillary Gel Electrophoresis (CGE), Affinity Electrophoresis, Capillary Electrochromatography (CEC)). • Principles and applications of: ELISA, Western blotting, SDS-PAGE and 2D SDS-PAGE.
Practical. HPLC, gas chromatography and capillary electrophoresis.
Students will use chromatographic and electrophoretic methods to check the purity of products. Students will analyze data from resulting chromatographs - resolution, retention times, column efficiency.
Assessment Breakdown%
Course Work50.00%
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
Practical/Skills Evaluation A two hour weekly practical session will provide the student with the opportunity to back up the theory covered in formal lectures with practical experience in a variety of analytical techniques, for example, HPLC, GC and capillary electrophoresis. Students will be required to submit weekly laboratory reports. Marks for these reports will be based on a students ability to record primary data, display data, comment on the meaning of the experiment data and the associated theory. 1,2,3,5 30.00 0 0 Every Second Week 0
No Project
No Practical
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 1,2,3,4,5 50.00 0 0 End-of-Semester 0
Reassessment Requirement
A repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

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 No Description 3.00 Every Week 3.00
Practical No Description 2.00 Every Week 2.00
Directed Reading No Description 3.00 Every Week 3.00
Independent Study No Description 3.00 Every Week 3.00
Total Weekly Learner Workload 11.00
Total Weekly Contact Hours 5.00
This course has no Part Time workload.
Recommended Book Resources
  • Skoog, D., Holler, F. and Crouch, S. 2007, Principles of instrumental analysis, Thomson
  • Rouessac, R. and Rouessac, A. 2007, Chemical analysis: Modern instrumentation methods, 2nd Ed., Wiley
  • Harris, D. 2005, Quantitative chemical analysis, 6th Ed., Cambridge University Press
  • Ardrey, B. 2003, Liquid chromatography-mass spectrometry, Wiley
  • Weinberger, R. 2001, Practical capillary electrophoresis, 2nd Ed., Academic Press
  • Neue, U. 1997, HPLC columns: Theory, technology and practice, Wiley
  • Kellner et al, Analytical Chemistry “A modern approach to analytical science”, 2nd Edition Ed., Wiley [ISBN: 3527305904]
This module does not have any article/paper resources
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
DK_SBIOP_8 Bachelor of Science (Honours) in Biopharmaceutical Science 2 Mandatory