CHEN40710 Downstream Processing & Sterile Fill Finish (PT)

Academic Year 2022/2023

The aim of this module is for students to gain an understanding of the different commercial unit operations involved in downstream processing (DSP) from cell harvest to final purification and will enable students with the skills required to develop an appropriate purification strategy for different types and characteristics of biologics.

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Curricular information is subject to change

Learning Outcomes:

On completion of this module students should be able to:
1. Identify the importance of downstream processing of biologics in Biomanufacturing
2. Identify the 3 key elements of a DSP strategy for both intracellular and extracellular products, namely capture, intermediate purification and polishing.
3. Understand the principles and associated advantages and disadvantages of the unit operations involved in capture using centrifugation, homogenization and filtration.
4. Understand the principles and associated advantages and disadvantages of using different types of filtration for harvest and purification, namely MF, UF, TFF, NF and DF.
5. Understand the principles and associated advantages and disadvantages of different types chromatography used for intermediate and polishing steps: affinity chromatography, ion-exchange, size-exclusion and hydrophobic interaction chromatography.
6. Understand the importance of viral clearance and inactivation steps.
7. Describe the different types of finished product available (solid or liquid)
8. Design a DSP strategy for a range of biologics including mAbs, ADCs and vaccines.

Student Effort Hours: 
Student Effort Type Hours
Autonomous Student Learning

104

Lectures

16

Total

120

Approaches to Teaching and Learning:
Lectures
Class based activities 
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
Assignment: Design DSP strategy for biologic Coursework (End of Trimester) n/a Graded No

85

Assignment: In-class exercies Throughout the Trimester n/a Graded No

15


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

• Feedback individually to students, post-assessment

How will my Feedback be Delivered?

Feedback can be requested by emailing the module teacher subsequently.

Name Role
Assoc Professor Susan McDonnell Lecturer / Co-Lecturer
John Milne Lecturer / Co-Lecturer