Module Details

Module Code: PHAR S8010
Full Title: Biopharmaceutical Analysis
Valid From:: Semester 1 - 2019/20 ( June 2019 )
Language of Instruction:English
Duration: 1 Semester
Credits:: 7.5
Module Owner:: annamarie rogers
Departments: Unknown
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.
 
Module Learning Outcome
On successful completion of this module the learner will be able to:
# Module Learning Outcome Description
MLO1 Discuss the use of gas chromatography (GC) for impurity profiling of biopharmaceuticals.
MLO2 Assess the use of high performance liquid chromatography (HPLC) techniques to analyse biopharmaceutical proteins at intact (native) and fragmented levels.
MLO3 Perform CE, MS, GC and HPLC in the laboratory and numerically evaluate separations.
MLO4 Characterise physiochemical properties of biopharmaceuticals using liquid chromatography- mass spectrometry/mass spectrometry (LC-MS/MS).
MLO5 Evaluate use of electrophoretic techniques (capillary electrophoresis (CE), polyacrylamide gel electrophoresis) to investigate product heterogeneity.
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
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).
Module Assessment
Assessment Breakdown%
Course Work10.00%
Practical30.00%
Final Examination60.00%
Module Special Regulation
 

Assessments

Full-time

Course Work
Assessment Type Class Test % of Total Mark 10
Marks Out Of 0 Pass Mark 0
Timing n/a Learning Outcome 1
Duration in minutes 0
Assessment Description
Evaluate understanding and application of knowledge gained in lectures and tutorials.
No Project
Practical
Assessment Type Practical/Skills Evaluation % of Total Mark 30
Marks Out Of 0 Pass Mark 0
Timing Every Second Week Learning Outcome 2,3
Duration in minutes 0
Assessment Description
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.
Final Examination
Assessment Type Formal Exam % of Total Mark 60
Marks Out Of 0 Pass Mark 0
Timing End-of-Semester Learning Outcome 1,2,4,5
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 2 x 1 hour lectures Every Week 2.00 2
Tutorial Contact 1 hour tutorial Every Week 1.00 1
Practical Contact 1 x 2.5 hour lab session Every Second Week 1.25 2.5
Directed Reading Non Contact Notes/Paper/Textbook Every Week 3.00 3
Independent Study Non Contact Self Every Week 3.00 3
Total Weekly Learner Workload 10.25
Total Weekly Contact Hours 4.25
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.
  • Kellner et al. Analytical Chemistry “A modern approach to analytical science”, 2nd Edition. Wiley, [ISBN: 3527305904].
  • Ardrey, B.. (2003), Liquid chromatography-mass spectrometry, Wiley.
  • Weinberger, R.. (2001), Practical capillary electrophoresis, 2nd. 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, p.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