BIO07016 2019 BIOPHARMACEUTICALS 2

General Details

Full Title

BIOPHARMACEUTICALS 2

Transcript Title

BIOPHARMACEUTICALS 2

Code

BIO07016

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)

Margaret Doherty

Programme Membership

SG_SPHAR_B07 201900 Bachelor of Science in Pharmaceutical Science with Drug Development SG_SPHAR_H08 201900 Bachelor of Science (Honours) in Pharmaceutical Science with Drug Development

Description

This course aims to provide the student with a broad understanding of the various aspects of the biomanufacturing process. The module will explore the technologies employed during upstream, downstream, formulation, fill-finish and delivery of biopharmaceuticals.

Learning Outcomes

On completion of this module the learner will/should be able to;

Identify and evaluate the key factors that are involved in upstream and downstream bioprocessing.

Identify key challenges involved in the formulation of biopharmaceuticals and explain the principal stages of sterile fill-finish operations.

Demonstrate knowledge of the key elements in a systematic approach to Biopharmaceutical Process Validation.

Compare routes of delivery for biopharmaceuticals (e.g. pulmonary, parenteral, transdermal) and evaluate current and novel drug delivery systems designed for biopharmaceuticals.

Recognise ethical and regulatory issues relating to the biopharmaceutical industry.

Teaching and Learning Strategies

Module Assessment Strategies

Assessment of the Biopharmaceuticals 2 module will include both continuous assessment and a terminal exam. Continuous assessment will involve a range of assessment types including case studies and multiple choice quizzes. A key focus of this module is to develop the student's team skills. To achieve this, students will be assigned a group 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

Module Dependencies

Prerequisites

None

Co-requisites

None

Incompatibles

None

Indicative Syllabus

The range of topics covered will include some of the following:

Upstream processing:

Key features of bioreactor design
Describe the main aspects of bioreactor control and operation
Bioreactor modes of operation
Process Analytical Technology

Downstream processing:

Chromatographic techniques
Filtration technology
Centrifugation
Electrophoresis
Virus removal

Formulation-Fill Finish:

Aspects of preformulation of relevance to Biopharmaceutical formulation
Dosage forms: Liquid, Frozen liquid, Lyophilized etc.
Main types of excipients used in biopharmaceutical formulation.
Lyophilization Technology.
Sterile fill-finish operations for biopharmaceuticals.

Validation:

Overview of Validation Methodologies with specific application to Biopharmaceutical Manufacture.
Risk Identification, Risk Assessment and Risk Management for Biopharmaceutical Manufacture e.g. FMEA.
Process Validation for Upstream and Downstream Processing
Validation Methodology for Viral Control of Biopharmaceuticals.

Drug Delivery:

Routes of Administration: Parenteral, Oral, Pulmonary, Nasal, Transdermal etc
Controlled release
Targeted delivery
Specialised delivery systems

Coursework & Assessment Breakdown

Coursework & Continuous Assessment

60 %

End of Semester / Year Formal Exam

40 %

Coursework Assessment

	Title	Type	Form	Percent	Week	Learning Outcomes Assessed
1	Case Study	Coursework Assessment	Assignment	10 %	Week 9	4
2	Multiple Choice	Coursework Assessment	Multiple Choice/Short Answer Test	20 %	OnGoing	1,2,3,4,5
3	Open Book Exam	Coursework Assessment	Open Book Exam	10 %	OnGoing	5
4	Group Project	Coursework Assessment	Group Project	20 %	Week 12	2,3,4

End of Semester / Year Assessment

	Title	Type	Form	Percent	Week	Learning Outcomes Assessed
1	Final Exam	Final Exam	Closed Book Exam	40 %	End of Term	1,2,3,4,5

Full Time Mode Workload

Type	Location	Description	Hours	Frequency	Avg Workload
Lecture	Tiered Classroom	Lecture	2	Weekly	2.00
Group Learning	Flat Classroom	Group Learning	1	Weekly	1.00
Independent Learning	UNKNOWN	Self Study	4	Weekly	4.00

Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Required & Recommended Book List

Recommended Reading
2007 Cell Culture and Upstream Processing Taylor & Francis Group
ISBN 9780415399692 ISBN-13 0415399696

Upstream processing refers to the production of proteins by cells genetically engineered to contain the human gene which will express the protein of interest. The demand for large quantities of specific proteins is increasing the pressure to boost cell culture productivity, and optimizing bioreactor output has become a primary concern for most pharmaceutical companies. Each chapter in Cell Culture and Upstream Processing is taken from presentations at the highly acclaimed IBC conferences as well as meetings of the European Society for Animal Cell Technology (ESACT) and Protein Expression in Animal Cells (PEACe) and describes how to improve yield and optimize the cell culture production process for biopharmaceuticals, by focusing on safety, quality, economics and operability and productivity issues. Cell Culture and Upstream Processing will appeal to a wide scientific audience, both professional practitioners of animal cell technology as well as students of biochemical engineering or biotechnology in graduate or high level undergraduate courses at university.

Recommended Reading
2018-05-11 Downstream Processing Createspace Independent Publishing Platform
ISBN 171893212X ISBN-13 9781718932128

What vendors make products that address the Downstream processing needs? How do we keep improving Downstream processing? What problems are you facing and how do you consider Downstream processing will circumvent those obstacles? How does Downstream processing integrate with other business initiatives? What management system can we use to leverage the Downstream processing experience, ideas, and concerns of the people closest to the work to be done? Defining, designing, creating, and implementing a process to solve a challenge or meet an objective is the most valuable role... In EVERY group, company, organization and department. Unless you are talking a one-time, single-use project, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?' This Self-Assessment empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Downstream processing investments work better. This Downstream processing All-Inclusive Self-Assessment enables You to be that person. All the tools you need to an in-depth Downstream processing Self-Assessment. Featuring new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Downstream processing improvements can be made. In using the questions you will be better able to: - diagnose Downstream processing projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices - implement evidence-based best practice strategies aligned with overall goals - integrate recent advances in Downstream processing and process design strategies into practice according to best practice guidelines Using a Self-Assessment tool known as the Downstream processing Scorecard, you will develop a clear picture of which Downstream processing areas need attention. Your purchase includes access details to the Downstream processing self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next. Your exclusive instant access details can be found in your book.

Recommended Reading
2018-07-22 Challenges in Protein Product Development Springer
ISBN 3319906011 ISBN-13 9783319906010

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

Recommended Reading
2018-10-24 New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins Springer
ISBN 3319971085 ISBN-13 9783319971087

This book review series presents current trends in modern biotechnology. The aim is to cover all aspects of this interdisciplinary technology where knowledge, methods and expertise are required from chemistry, biochemistry, microbiology, genetics, chemical engineering and computer science. Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.

Module Resources

Non ISBN Literary Resources

Journal Resources

URL Resources

Other Resources

None

Additional Information

None