BIO08027 2019 BIOPHARMACEUTICAL VALIDATION

General Details

Full Title
BIOPHARMACEUTICAL VALIDATION
Transcript Title
BIOPHARMACEUTICAL VALIDATION
Code
BIO08027
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)
Kieran Tobin, Stephen Daly
Programme Membership
SG_SMEDI_H08 201900 Bachelor of Science (Honours) in Science in Medical Biotechnology SG_SMEDI_K08 201900 Level 8 Honours Degree Add-on in Science in Medical Biotechnology
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 highlight and evaluate the various risks inherent in bioprocessing 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.

Categorise the principal risks associated with the manufacture of modern biopharmaceuticals and tools to evaluate them        

4.

Evaluate the main steps involved in the process validation of  upstream  (cell culture processing) and downstream (protein purification) processes.  

5.

Explain the validation approaches for cleaning, sterilisation and viral control technologies in the manufacture of  biopharmaceuticals. 

6.

Communicate and explain scientific data relating to biopharmaceutical validation.

Teaching and Learning Strategies

This module is taught face to face in the lecture room. It will combine a number of strategies including visualisation (e.g. audio clips), group work and some enquiry based learning. Lecture content will be the primary method towards achieving this. However, some workshops will be set up in the class giving students scenarios to work through and apply what they have learned. 

Module Assessment Strategies

Assessment of the Biopharmaceutical Validation module will include a combination of both continuous assessment and a terminal exam. The continuous assessment will be broken into multiple choice question exams and projects/workshop write-ups.  A key focus of this module is to develop the student's team skills. To achieve this, students will be assigned a validation project and be expected to participate constructively within a complex team environment. The team project will require the student's to work together to solve complex technical problems, plan for effective project implementation and manage the organisation of tasks, people and resources.  

Repeat Assessments

Students will have opportunities to re-submit work or repeat the terminal exam 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.   

Understand the concept of the validation life cycle

Risk Identification, Risk Assessment and Risk Management for Biopharmaceutical Manufacture e.g. FMEA. 

Process Validation for Upstream Processing - Cell Culture Processing. 

Process Validation for Downstream Processing - Protein Purification. 

Validation Methodology for Viral Control of Biopharmaceuticals. 

Equipment Qualification (CQV) and V model for validation

Analytical Method Validation.

Cleaning and Sterilisation Validation.

Understand the relationship between Validation, Technology Transfer and Product Life Cycle.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
40 %
End of Semester / Year Formal Exam
60 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 MCQ 1 Continuous Assessment Multiple Choice 10 % Week 6 1,2
2 MCQ 2 Continuous Assessment Multiple Choice 10 % Week 12 3,4,5
3 Project Continuous Assessment Project 20 % Week 10 2,3,4,5,6

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam Closed Book Exam 60 % End of Term 1,2,3,4,5,6
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Tiered Classroom Lecture 1 Weekly 1.00
Problem Based Learning Flat Classroom Problem Based Learning 1 Weekly 1.00
Independent Learning UNKNOWN Self Study 5 Weekly 5.00
Total Full Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Required Reading
2017-11 Biopharmaceutical Processing
ISBN 0081006233 ISBN-13 9780081006238

Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference

Required Reading
2007-09-25 Validation of Pharmaceutical Processes, Third Edition CRC Press
ISBN 0849370558 ISBN-13 9780849370557

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process. Presenting theoretical knowledge and applied practical considerations, this title provides an in-depth discussion of recent advances in sterilization identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions

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

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

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