SCI08003 2019 Biopharmaceutical Analysis

General Details

Full Title
Biopharmaceutical Analysis
Transcript Title
Biopharmaceutical Analysis
N/A %
Subject Area
SCI - Science
LIFE - Life Sciences
08 - NFQ Level 8
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Carmel Moran, Margaret Doherty
Programme Membership
SG_SPHAR_H08 201900 Bachelor of Science (Honours) in Pharmaceutical Science SG_SPHAR_K08 201900 Bachelor of Science (Honours) in Science in Pharmaceutical Science

This module aims to provide students with a knowledge and understanding of the various analytical methods used in biopharmaceutical analysis.

Learning Outcomes

On completion of this module the learner will/should be able to;


Describe antibodies and vaccines.  Compare and contrast a diverse range of immunoassays and bioassays.


Compare and contrast various protein purification methods used in the (bio)pharmaceutical industry.


Evaluate and discuss analytical techniques including both instrumental and biological techniques used on (bio)pharmaceutical products.


Identify, discuss and employ various detection and separation systems used in (bio)pharmaceutical analyses.


Communicate and report the findings of experimental analysis in an individual and/or group format taking into consideration good laboratory practice.

Teaching and Learning Strategies

This module will be delivered full-time. This will include lectures and laboratory practicals augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a means of assessment (e.g. quizzes, uploading assignments and journals).

Module Assessment Strategies

This module is 60% Continuous Assessment and 40% Final Exam.

Continuous assessment will provide the student with the opportunity to demonstrate the learning outcomes and monitor the student's progress. The continuous assessment is broken down into practical assessment (40%) and theory assessment (20%).

Laboratory skills and report writing ability (40%) are assessed as part of the practical work performed during the module. A minimum attendance of 75% is required in order to meet the learning outcomes of the practical component of this module. Failure to meet this requirement may result in repeat attending the module.

The theory continuous assessment comprises of MCQ quizzes carried out throughout the semester.

The final exam is designed to test the ability of the student to retain and interpret the information obtained during the course. The student must reach an assigned gate (mark) in the final exam and achieve 40% overall to pass the subject.

Repeat Assessments

Repeat Continuous Assessment and/or Final Exam

Module Dependencies


Indicative Syllabus

Describe antibodies and vaccines.  Compare and contrast a diverse range of immunoassays and bioassays.

Antibodies, vaccines and immunoassays

Enzyme activity and enzyme inhibition 


Compare and contrast various protein purification methods used in the (bio)pharmaceutical industry.

Protein purification and assessment of protein purity

A variety of protein purification methods will be evaluated, compared and contrasted including affinity chromatography and hydrophobic interaction chromatography.

Evaluate and discuss analytical techniques including both instrumental and biological techniques used on (bio)pharmaceutical products.

Chromatography of biomolecules - reverse phase, ion exchange, size exclusion

Capillary electrophoresis with various detection systems

Mass Spectrometry coupled with liquid chromatography and capillary electrophoresis

Identify, discuss and employ various detection and separation systems used in (bio)pharmaceutical analyses.

Liquid chromatography (RP/IC and SE) 

Capillary Electrophoresis

Liquid Chromatography Mass Spectrometry

Communicate and report the findings of experimental analysis in an individual and/or group format taking into consideration good laboratory practice.

Recording of data using Good Laboratory Practice. Report writing demonstrating an understanding of the findings and an ability to critically evaluate the data obtained.



Coursework & Assessment Breakdown

Coursework & Continuous Assessment
60 %
End of Semester / Year Formal Exam
40 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Theory continuous assessment. Continuous Assessment Multiple Choice 10 % Week 7 3,4
2 Theory continuous assessment Continuous Assessment Multiple Choice 10 % Week 13 1,2
3 Practical Evaluation Practicals/workshops Continuous Assessment Practical Evaluation 40 % OnGoing 3,4,5

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final exam. Final Exam Closed Book Exam 40 % End of Term 1,2,3,4

Full Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Laboratory Practical Science Laboratory Laboratory Practical 2 Weekly 2.00
Lecture Lecture Theatre Lecture 2 Weekly 2.00
Independent Learning UNKNOWN Self Study 3 Weekly 3.00
Total Full Time Average Weekly Learner Contact Time 4.00 Hours

Required & Recommended Book List

Required Reading
2016-06-01 Introduction to Mass Spectrometry of Biomolecules Nova Science Publishers
ISBN 1634846648 ISBN-13 9781634846646

The theses, lectures and solved problems within this book give an introduction to principles of mass spectrometry related to the analysis of biomolecules. The book focuses on MS and MS/MS analysis of peptides, oligosaccharides, lipids, glycoconjugates and polyphenols. The basic properties of modern MS ionization techniques and mass analyzers are presented, as well as appropriate MS methods for each class of biomolecules in modern biomedical scientific research. The biggest part of this book is focused on MS/MS analysis of biomolecules: how the MS and MS/MS data are generated, what are the basic strategies for their structural analysis, as well as how to interpret the respective MS and MS/MS data. This book also covers principles and examples of advanced MS/MS analyses, serving as a platform towards an intermediate level of understanding scientific research carried out in the field of structural MS analysis of biomolecules. It is the authors hope that the reader will be able to understand principles of MS analyses related to their scientific and/or analytical interest, as well as design/help to propose MS and MS/MS experiments, as well as interpret the obtained data. This book is primarily written for students with basic knowledge of general, organic and analytical chemistry, and who are interested in applying MS-based methodologies in biomedical research fields, as well as interested in pursuing a career in mass spectrometry. Therefore it is best suited for senior undergraduate students and first/second year Ph.D. students. However, since MS instrumentation is rapidly adopted on all levels of scientific as well as analytical laboratories, the book should prove useful to scientists as well as analysts interested in applying MS in their upgraded laboratories. The author hopes that the reader, after studying the content presented, will be able to read primary scientific literature containing MS data to learn more about specific topics of interest, as well as be more capable of choosing a MS-related career path. For senior scientists, this book can offer some basic insights related to choosing a post-doc laboratory, or simply easier and more fruitful cooperation with mass spectrometrists.

Required Reading
2013 Capillary Electrophoresis of Biomolecules
ISBN 1627032967 ISBN-13 9781627032964

Capillary electrophoresis (CE) is a relatively new separation technique suitable for handling small amounts of sample very important in bioanalytical research and in various clinical, diagnostic, genetic, and forensic applications. In Capillary Electrophoresis of Biomolecules: Methods and Protocols, expert researchers in the field provide key techniques to investigate CE focusing on simple and complex carbohydrates (polysaccharides), aminoacids, peptides and proteins, enzymes, and nucleic acids. Along with practical procedures, reviews discussing CE applications related to bio(macro)molecules are also included. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and key tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Capillary Electrophoresis of Biomolecules: Methods and Protocols provides the reader with the latest break throughs and improvements in CE and CE techniques applied to several classes of bio(macro)molecules.

Recommended Reading
2018-11-30 Handbook on Protein Purification
ISBN 1536143650 ISBN-13 9781536143652

Proteins are important biomolecules that are vital for the cellular structure and function. They perform a vast array of functions within organisms, including the catalysis of metabolic reactions, DNA replication, response to stimuli, and transporting molecules from one location to another. The technological advances in the omics areas (e.g., genomics, transcriptomics, proteomics, metagenomics, etc.) have dramatically increased the rate of discovering new proteins. Some of them hold large opportunities for innovative research and the development of commercial products and applications. It is worth noting that the global protein ingredients market is poised to grow over the next decade to reach approximately 58.49 billion USD by 2022, with the protein therapeutics market valuing around USD 315.9 billion by 2025. Interestingly, about seventy monoclonal antibody products will be on the market by 2020 with a combined worldwide sales of about 125 billion USD.The most significant parameter for the successful commercial exploitation of proteins rely on the development of an efficient and effective isolation and purification technology, known as protein downstream processing. Downstream processing refers to the technology that involves the isolation and production of purified products from natural sources such as animal tissues, plant tissues, microorganisms or fermentation broth. The most important element of this technology is the high purification processes, most important of which is chromatography and in particular affinity chromatography.This book provides information on the resent developments of protein downstream processing and deals with the information gained over the last years from the application of protein purification technologies on different research areas. Each chapter gives key examples that cover a wide range of diverse scientific disciplines in order to provide the reader with a representative sample of the current status of the field. The present book would definitely be an ideal source of scientific information to the advanced students, junior researchers, and scientists involved in cellular and molecular biology, biochemistry, microbiology, biotechnology and other related areas.

Recommended Reading
2016-01-14 Introduction to Protein Science
ISBN 0198716842 ISBN-13 9780198716846

Not only are proteins the fundamental building blocks of all life forms, but they also have a wide range of functions - from forming enzymes acting as catalysts for specific reactions, to crucial molecules such as antibodies in the immune system, and as signalling molecules between cells. Introduction to Protein Science, 3rd edition provides a rich and broad introduction to this fascinating field by covering not only the structureand function of proteins, but also the methods and experimental techniques used to study them. The practical applications of our knowledge to diverse fields such as biotechnology and medicine are emphasizedthroughout, to help students appreciate the relevance of the subject to the real world.

Recommended Reading
2015-12-07 Fundamentals of Protein Structure and Function Springer
ISBN 3319199196 ISBN-13 9783319199191

This book serves as an introduction to protein structure and function. Starting with their makeup from simple building blocks, called amino acids, the 3-dimensional structure of proteins is explained. This leads to a discussion how misfolding of proteins causes diseases like cancer, various encephalopathies, or diabetes. Enzymology and modern concepts of enzyme kinetics are then introduced, taking into account the physiological, pharmacological and medical significance of this often neglected topic. This is followed by thorough coverage of hmoglobin and myoglobin, immunoproteins, motor proteins and movement, cell-cell interactions, molecular chaperones and chaperonins, transport of proteins to various cell compartments and solute transport across biological membranes. Proteins in the laboratory are also covered, including a detailed description of the purification and determination of proteins, as well as their characterisation for size and shape, structure and molecular interactions. The book emphasises the link between protein structure, physiological function and medical significance. This book can be used for graduate and advanced undergraduate classes covering protein structure and function and as an introductory text for researchers in protein biochemistry, molecular and cell biology, chemistry, biophysics, biomedicine and related courses. About the author: Dr. Buxbaum is a biochemist with interest in enzymology and protein science. He has been working on the biochemistry of membrane transport proteins for nearly thirty years and has taught courses in biochemistry and biomedicine at several universities.

Required Reading
2015-05-29 Quantitative Chemical Analysis W. H. Freeman
ISBN 146413538X ISBN-13 9781464135385

The gold standard in analytical chemistry, Dan Harris Quantitative Chemical Analysis provides a sound physical understanding of the principles of analytical chemistry and their applications in the disciplines.

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