Full Title BIOPHARMACEUTICAL VALIDATION

Short Title BIOPHARMACEUTICAL VALIDATION

Code BIO08014
Level 08
Credit 05

Author Tobin, Kieran
Department Applied Sciences

Subject Area Bio Tech/Eng/Chem
Attendence N/A%
Fee

Description
This course aims to provide the student with a broad understanding of the various aspects of process and support systems validation for the manufacturing of modern biopharmaceuticals. It will deal with the various risks inherent in bioprocessing technologies and how the application of effective validation methodologies assists in the control and management of such risks.

Indicative Syllabus
Overview of Validation Methodologies with specific application to Biopharmaceutical Manufacture.

Risk Identification, Risk Assessment and Risk Management for Biopharmaceutical Manufacture.

Process Validation for Upstream Processing - Cell Culture Processing.

Process Validation for Downstream Processing - Protein Purification.

Validation Methodology for Viral Control of Biopharmaceuticals.

Validation of Support Services for Bioprocessing.

Learning Outcomes
On completion of this module the learner will/should be able to
  1. Describe the key elements in a systematic approach to validation with particular emphasis on their application to bioprocessing.
  2. List and describe the main steps involved in the process validation of the biopharmaceutical manufacture upstream process (cell culture processing).  

  3. List and describe the main steps involved in the process validation of the biopharmaceutical manufacture downstream process (protein purification).  

  4. Describe the validation approach for  viral control technologies for biopharmaceutical manufacture.                     

  5. Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.

  6. Communicate and explain scientific data relating to biopharmaceutical validation.


Assessment Strategies
Continuous Assessment of Course Work - 30% of marks.

End of term online exam - 30% of marks.

Mini research project - 40% of marks.

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 70 %
End of Semester / Year Formal Examination 30 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Open Book Exam Online 1,2 15 Week 4
Open Book Exam Online 3,4 15 Week 9
Individual Project Mini Research 5,6 40 Week 15


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Other Exam Online 1,2,3,4 30 Week 13


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Lecture Not Specified Online 2 Weekly 2.00
Directed Learning Not Specified Course Notes 4 Weekly 4.00
Independent Learning UNKNOWN Mini Research Activities 4 Weekly 4.00

Total Average Weekly Learner Workload 6.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book Resources
'Biotechnology - Quality Assurance and Validation' by K.E Avis, C.M.Wagner and V.L. Wu. Interpharm / CRC 1999. ISBN - 1-57491-089-2.

PDA Journal of Pharmaceutical Science and Technology. Technical Report No. 42: 'Process Validation of Protein Manufacturing'.

'Pharmaceutical Biotechnology - Concepts and Applications' by Gary Walsh. Wiley Publications. 2007. ISBN - 978-0-470-01244-4.

'Bioprocess Engineering - Basic Concepts' by Shuler,M.L. and Kargi F. Prentice-Hall. 2002. ISBN - 0-13-081908-5.
Other Resources
None
Url Resources
Additional Info