Module Details

Module Code: PHAR S8010
Full Title: Biopharmaceutical Analysis
Valid From: Semester 1 - 2013/14 ( September 2013 )
Language of Instruction: 
Duration: 1 Semester
Credits: 7.5
Module Owner:: annamarie rogers
Departments: Unknown
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.
Module Learning Outcome
On successful completion of this module the learner will be able to:
# Module Learning Outcome Description
MLO1 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.
MLO2 Perform High Performance Liquid Chromatography, Gas Chromatography and Capillary Eectrophoresis in the laboratory.
MLO3 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.
MLO4 Compare and contrast specialised techniques such as capillary electrophoresis, ELISA, Western Blot analysis, SDS-PAGE and 2D SDS-PAGE.
MLO5 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).
Pre-requisite learning
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named DkIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
No recommendations listed
Module 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.
Module Assessment
Assessment Breakdown%
Course Work50.00%
Final Examination50.00%
Module Special Regulation


Full Time

Course Work
Assessment Type Practical/Skills Evaluation % of Total Mark 30
Marks Out Of 0 Pass Mark 0
Timing Every Second Week Learning Outcome 1,2,3,5
Duration in minutes 0
Assessment Description
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.
Assessment Type Project % of Total Mark 20
Marks Out Of 0 Pass Mark 0
Timing Week 6 Learning Outcome 1,2,3,4,5
Duration in minutes 0
Assessment Description
Students will discuss how the techniques in the module “Biopharmaceutical analysis” have been used in either (a) the production and purification of the assigned Biopharmaceutical drug, (b) its monitoring following administration and (c) influence on the body and/or (d) new research and development and optimisation of the drugs (dosage, delivery mode). This project will improve students ability to research information in an advanced topic area.
No Project
No Practical
Final Examination
Assessment Type Formal Exam % of Total Mark 50
Marks Out Of 0 Pass Mark 0
Timing End-of-Semester Learning Outcome 1,2,3,4,5
Duration in minutes 0
Assessment Description
End-of-Semester Final Examination
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

Workload: Full Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact No Description Every Week 3.00 3
Practical Contact No Description Every Week 2.00 2
Directed Reading Non Contact No Description Every Week 3.00 3
Independent Study Non Contact No Description Every Week 3.00 3
Total Weekly Learner Workload 11.00
Total Weekly Contact Hours 5.00
This module has no Part Time workload.
Module Resources
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. Wiley.
  • Harris, D.. (2005), Quantitative chemical analysis, 6th. Cambridge University Press.
  • Ardrey, B.. (2003), Liquid chromatography-mass spectrometry, Wiley.
  • Weinberger, R.. (2001), Practical capillary electrophoresis, 2nd. 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. Wiley, [ISBN: 3527305904].
This module does not have any article/paper resources
Other Resources