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 SG_SPHAR_H08 201900 Bachelor of Science (Honours) in Pharmaceutical Science
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;

1.

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

2.

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

3.

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

4.

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

5.

Recognise ethical and regulatory issues relating to the biopharmaceutical industry.

Teaching and Learning Strategies

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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

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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 Continuous Assessment Assignment 10 % Week 9 4
2 Multiple Choice Continuous Assessment Multiple Choice 20 % OnGoing 1,2,3,4,5
3 Open Book Exam Continuous Assessment Open Book Exam 10 % OnGoing 5
4 Group Project Continuous 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

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Journal Resources

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URL Resources

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Other Resources

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Additional Information

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