Full Title BIOPHARMACEUTICAL VALIDATION

Short Title BIOPHARMACEUTICAL VALIDATION

Code BIO07024
Level 07
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 general understanding of the various aspects of process and support systems validation for the manufacturing of modern biopharmaceuticals. It will also deal with the various risks inherent in bioprocessing technologies and how the application of effective validation systems and methodologies assists in the control and management of such risks.

Indicative Syllabus
An overview of Validation Systems and Methodologies for Biopharmaceutical Manufacture.

Risk Identification and Risk Assessment for Biopharmaceutical Manufacture.

Process Validation for Upstream Cell Culture Processing.

Process Validation for Downstream Protein Purification and Fill-finish.

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 main stages involved in a systematic approach to the validation of bioprocessing systems.

  2. Describe the main steps involved in the process validation of  biopharmaceutical cell culture processing.

  3. Describe the main steps involved in the process validation of biopharmaceutical protein purification and fill-finish operation.

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

  5. Perform some 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 - 60% of marks.

End of term final exam - 40% of marks.


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

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 60 %
End of Semester / Year Formal Examination 40 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Continuous Assessment Online Exams 1,2,3,4 30 OnGoing
Assignment 5,6 30 OnGoing


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Final Exam 1,2,3,4 40 End of Term


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 Lecture 1 Weekly 1.00
Directed Learning Not Specified Course Notes etc. 3 Weekly 3.00
Independent Learning UNKNOWN Mini Research 3 Weekly 3.00

Total Average Weekly Learner Workload 4.00 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