CHEN40630 Bioanalytical Science for Biopharma

Academic Year 2021/2022

This module will provide students with fundamental and applied knowledge on analytical and bioanalytical techniques used for the characterisation of biopharmaceuticals and the monitoring of processes used for biopharmaceutical production. Students will receive an appreciation on how to assess the quality of analytical data using statistical techniques. Students will learn about the theoretical aspects of spectroscopic, chromatographic, electrophoretic and mass spectrometric approaches for the characterisation of recombinant proteins and will then be presented with an understanding as to the practical usage of these methods to answer key challenges within the biopharmaceutical manufacturing industry.

A non-standard mark-to-grade conversion system is used in this module for grades of C- and above (i.e. C-: 50.00-54.99; C: 55.00-59.99; C+: 60.00-64.99; B-: 65.00-69.99; B: 70.00-74.99; B+: 75.00-79.99; A-: 80.00-84.99; A: 85.00-89.99; A+:90.00-100.00).

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Curricular information is subject to change

Learning Outcomes:

On completion of this module students should be able to:
1. Understand the regulatory requirements for biopharmaceutical characterisation and apply their theoretical knowledge to devise strategies for biopharmaceutical characterisation.
2. Evaluate and critique the quality of analytical data using appropriate statistical tests.
3. Understand the fundamentals of optical spectroscopic techniques and their quantitative application in analytical and bioanalytical assays.
4. Understand the fundamentals of analytical separations, particularly chromatography and electrophoresis, and the application of these techniques for the characterisation of biopharmaceuticals and monitoring bioprocesses.
5. Appreciate the importance of mass spectrometry for biopharmaceutical characterisation.
6. Understand the principles behind nucleic acid analysis and the utilisation of nucleic acids as components of assays.

Student Effort Hours: 
Student Effort Type Hours
Lectures

24

Autonomous Student Learning

96

Total

120

Approaches to Teaching and Learning:
Lectures
Problem-based learning 
Requirements, Exclusions and Recommendations

Not applicable to this module.


Module Requisites and Incompatibles
Not applicable to this module.
 
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Continuous Assessment: Series of assignments with short questions and problems Throughout the Trimester n/a Graded Yes

100


Carry forward of passed components
Yes
 
Resit In Terminal Exam
Spring No
Please see Student Jargon Buster for more information about remediation types and timing. 
Feedback Strategy/Strategies

• Feedback individually to students, post-assessment
• Group/class feedback, post-assessment

How will my Feedback be Delivered?

Not yet recorded.

Name Role
Dr Jonathan Bones Lecturer / Co-Lecturer