BIO08046 2019 BIOPHARMACEUTICAL VALIDATION
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.
On completion of this module the learner will/should be able to;
Understand and apply the key elements of equipment qualification and analytical test method validation
Evaluate the main steps involved in the process validation of the biopharmaceutical manufacture upstream process (cell culture processing).
Evaluate the main steps involved in the process validation of the biopharmaceutical manufacture downstream process (protein purification).
Describe the validation approach for viral control technologies for biopharmaceutical manufacture.
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
Students will have opportunities to re-submit work as agreed with their lecturer.
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
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Open Book Exam Online||Coursework Assessment||Multiple Choice/Short Answer Test||15 %||Week 6||1,2|
|2||Open Book Exam Online||Coursework Assessment||Multiple Choice/Short Answer Test||15 %||Week 10||3,4|
|3||Other Exam Online||Coursework Assessment||Open Book Exam||30 %||Week 13||1,3,4,5|
|4||Individual Project Mini Research||Coursework Assessment||UNKNOWN||40 %||Week 15||1,2,3,4,5,6|
Part Time Mode Workload
|Directed Learning||Not Specified||Course Notes||4||Weekly||4.00|
|Independent Learning||UNKNOWN||Mini Research Activities||4||Weekly||4.00|
Required & Recommended Book List
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.
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.
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.
PDA Journal of Pharmaceutical Science and Technology. Technical Report No. 42: ‘Process Validation of Protein Manufacturing'.