Full Title:Biopharmaceutical Analysis
Language of Instruction:English
Module Code:PHAR S8010
Credits: 7.5
Valid From:Semester 1 - 2019/20 ( June 2019 )
Module Delivered in 2 programme(s)
Module Description:The aim of this module is to provide students with a detailed understanding of a range of analytical techniques and application areas within the biopharmaceutical industry.
Learning Outcomes:
On successful completion of this module the learner should be able to
  1. Discuss the use of gas chromatography (GC) for impurity profiling of biopharmaceuticals.
  2. Assess the use of high performance liquid chromatography (HPLC) techniques to analyse biopharmaceutical proteins at intact (native) and fragmented levels.
  3. Perform CE, MS, GC and HPLC in the laboratory and numerically evaluate separations.
  4. Characterise physiochemical properties of biopharmaceuticals using liquid chromatography- mass spectrometry/mass spectrometry (LC-MS/MS).
  5. Evaluate use of electrophoretic techniques (capillary electrophoresis (CE), polyacrylamide gel electrophoresis) to investigate product heterogeneity.

Module Content & Assessment

Indicative Content
Impurity profiling of biopharmaceuticals using gas chromatography (GC)
Principle, applications and instrumentation used for GC.
HPLC techniques for biopharmaceutical analysis
Use of various HPLC techniques to analyse proteins at intact (native) and fragmented levels including: Reversed Phase (RPLC), Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX), Hydrophilic Interaction Chromatography (HILIC), Affinity Chromatography
Physiochemical characterisation using LC-MS/MS
Liquid chromatography–tandem mass spectrometry (LC–MS/MS) following digestion for primary amino-acid sequencing (Edman degradation). Electrospray ionisation–mass spectrometry (ESI–MS) for intact molecular weight determination. Matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDI–TOF MS) for quantitative and qualitative analyses of N- and O-glycosylation. (MS analysers - TOF; Quadrupole; Ion trap)
Electrophoretic evaluation of the biopharmaceutical
Capillary electrophoresis (CGE for fragment measurements; cIEF for charge heterogeneity) SDS-PAGE; Western Blotting, ELISA
Apply practical competence in HPLC, GC, MS and CE & evaluate results
Students will use chromatographic and electrophoretic methods to check the purity of products. Students will analyze data obtained both qualitatively and quantitatively (resolution, retention time, column efficiency, capacity factor, selectivity factor, resolution).
Assessment Breakdown%
Course Work10.00%
End of Module Formal Examination60.00%

Full Time

Course Work
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Class Test Evaluate understanding and application of knowledge gained in lectures and tutorials. 1 10.00 0 0 n/a 0
No Project
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Practical/Skills Evaluation A biweekly practical session will provide the student with the opportunity to support theoretical knowledge in a variety of analytical techniques, for example, HPLC, GC, CE and MS. Students will be required to submit 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. 2,3 30.00 0 0 Every Second Week 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 1,2,4,5 60.00 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 2 x 1 hour lectures 2.00 Every Week 2.00
Tutorial 1 hour tutorial 1.00 Every Week 1.00
Practical 1 x 2.5 hour lab session 2.50 Every Second Week 1.25
Directed Reading Notes/Paper/Textbook 3.00 Every Week 3.00
Independent Study Self 3.00 Every Week 3.00
Total Weekly Learner Workload 10.25
Total Weekly Contact Hours 4.25
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
  • Kellner et al, Analytical Chemistry “A modern approach to analytical science”, 2nd Edition Ed., Wiley [ISBN: 3527305904]
  • Ardrey, B. 2003, Liquid chromatography-mass spectrometry, Wiley
  • Weinberger, R. 2001, Practical capillary electrophoresis, 2nd Ed., Academic Press
Recommended Article/Paper Resources
  • Zaifang Zhu, Joann J. Lu, and Shaorong Liu* 2012, Protein Separation by Capillary Gel Electrophoresis: A Review, Anal Chim Acta, 709, 10
  • Bhupinder Singh Sekhon 2011, An overview of capillary electrophoresis: Pharmaceutical, J Pharm Educ Res, 2
  • Ruedi Aebersold & Matthias Mann 2003, Mass spectrometry-based proteomics, Nature, 422
  • ICH Q6B 1999, Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
Dk_NLBIO_8 Bachelor of Science (Honours) in Biopharmaceutical Science (2020) 8 Mandatory
DK_NLBIA_8 Bachelor of Science (Honours) in Biopharmaceutical Science (add-on) (2020) 2 Mandatory