BIO08046 2019 BIOPHARMACEUTICAL VALIDATION

General Details

Full Title
BIOPHARMACEUTICAL VALIDATION
Transcript Title
BIOPHARMACEUTICAL VALIDATION
Code
BIO08046
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Stephen Daly
Programme Membership
SG_SBIOP_E08 201900 Level 8 Certificate in Science in Biopharmaceutical Science SG_SBIOP_K08 201900 Bachelor of Science (Honours) in Biopharmaceutical Science. SG_SBIOM_H08 202000 Bachelor of Science (Honours) in Science in Biomedical and BioIndustrial Sciences
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. 

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.

Understand and apply the key elements of equipment qualification and analytical test method validation

3.

Evaluate the main steps involved in the process validation of the biopharmaceutical manufacture upstream process (cell culture processing).  

4.

Evaluate the main steps involved in the process validation of the biopharmaceutical manufacture downstream process (protein purification).  

5.

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

6.

Communicate and explain scientific data relating to biopharmaceutical validation.

Teaching and Learning Strategies

This module can be taught using a via on-line lectures. A range of Computer-Aided Learning (CAL) packages are also used to support this module (e.g. Moodle, Adobe Connect, Panopto, Camtasia)
Students are provided with electronic materials for self-assessment and preparation for assessments/assignments. Self-directed, student centred, independent learning is a core aspect through completion of module coursework.

Module Assessment Strategies

The assessment approach for this module will be 100% continuous employed including some of the following:
Enquiry based Projects, Assignments/Mini Projects including Viva/Presentation
Short-form assessment exams incl. MCQs, Short answer and Long Answer Questions

Repeat Assessments

Students will have opportunities to re-submit work as agreed with their lecturer.

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

Overview of Validation Methodologies with specific application to Biopharmaceutical Manufacture.   

Validation life cycle

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. 

Equipment Qualification and V model for validation

Cleaning and sterilisation Validation

 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Open Book Exam Online Continuous Assessment Multiple Choice 15 % Week 6 1,2
2 Open Book Exam Online Continuous Assessment Multiple Choice 15 % Week 10 3,4
3 Other Exam Online Continuous Assessment Open Book Exam 30 % Week 13 1,3,4,5
4 Individual Project Mini Research Continuous Assessment UNKNOWN 40 % Week 15 1,2,3,4,5,6

Part Time Mode Workload


Type Location Description Hours Frequency Avg 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 Part Time Average Weekly Learner Contact Time 6.00 Hours

Required & Recommended Book List

Required Reading
1998-10-31 Biotechnology CRC Press
ISBN 1574910892 ISBN-13 9781574910896

Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more.

Required Reading
2007-08-13 Pharmaceutical Biotechnology John Wiley & Sons
ISBN 9780470012444 ISBN-13 0470012447

Offers a comprehensive introduction to the principles and concepts of pharmaceutical biotechnology.

Required Reading
2002 Bioprocess Engineering Pearson College Division
ISBN 0130819085 ISBN-13 9780130819086

This concise yet comprehensive text introduces the essential concepts of bioprocessing - internal structure and functions of different types of microorganisms, major metabolic pathways, enzymes, microbial genetics, kinetics and stoichiometry of growth and product information - to traditional chemical engineers and those in related disciplines. It explores the engineering principles necessary for bioprocess synthesis and design, and illustrates the application of these principles to modern biotechnology for production of pharmaceuticals and biologics, solution of environmental problems, production of commodities, and medical applications.

Module Resources

Non ISBN Literary Resources

 

See booklist

Journal Resources

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

URL Resources

https://www.fda.gov

https://www.ema.europa.eu

www.ICH.org

https://ec.europa.eu/health/documents/eudralex/vol‑4_en  

Other Resources

None

Additional Information

None