BIO07024 2019 BIOPHARMACEUTICAL VALIDATION

General Details

Full Title
BIOPHARMACEUTICAL VALIDATION
Transcript Title
BIOPHARMACEUTICAL VALIDATION
Code
BIO07024
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Paul Walsh, Stephen Daly
Programme Membership
SG_SBIOP_J07 201900 Bachelor of Science in Science in Biopharmaceutical Science SG_SBIOE_E07 201900 Certificate in Science in Bioprocess Engineering L7
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. 

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.

Teaching and Learning Strategies

N/A

Module Assessment Strategies

Continuous Assessment of Course Work - 50% of marks.

End of term final exam - 50% of marks.

 

Repeat Assessments

N/A

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

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 life cycle

Equipment qualficiation and V model

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Multiple Choice Questions Continuous Assessment Multiple Choice 10 % Week 5 1,2,3,4
2 Assignment Continuous Assessment Project 30 % End of Semester 5,6
3 Multiple Choice Questions Continuous Assessment Multiple Choice 10 % Week 12 3,4,5,6

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam Closed Book Exam 50 % End of Term 1,2,3,4
             
             

Part Time Mode Workload


Type Location Description Hours Frequency Avg 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 Part Time Average Weekly Learner Contact Time 4.00 Hours

Module Resources

Non ISBN Literary 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.

Journal Resources

N/A

URL Resources

N/A

Other Resources

None

Additional Information

None