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BIO09085 2019 Downstream Bioprocessing

General Details

Full Title
Downstream Bioprocessing
Transcript Title
Downstream Bioprocessing
Code
BIO09085
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
09 - Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Eva Campion
Programme Membership
SG_SBPRO_M09 201900 Master of Science in Bioprocessing SG_SBIOP_S09 202100 Postgraduate Certificate in Bioprocessing
Description

This module addresses the theory and practical aspects of downstream processing as it pertains to the manufacture of modern biologic products. The relevant learning is acquired through a series of lectures and the completion of a sequence of laboratory-based and pilot-plant based practical classes, with experiments designed to impart the required knowledge, know-how and skills relevant to this area.

Learning Outcomes

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

1.

Identify and evaluate key factors involved in the design of a typical downstream process for biopharmaceuticals.

2.

Analyse the theory and evaluate key factors involved in chromatography selection for downstream processing applications.

3.

Explain and evaluate filtration systems for recovery, concentration and viral clearance.

4.

Demonstrate a range of knowledge and skill in standard and specialised techniques used in downstream protein capture and purification at both lab and pilot-plant scale of operation.

5.

Interpret, critically evaluate and effectively communicate results obtained from the various bioprocessing practicals.

Teaching and Learning Strategies

This module will be delivered full time and will include lectures, laboratory practicals (at IT Sligo), and pilot-plant practicals as part of a site visit to NIBRT. A blended learning approach will be adopted where students will attend both online and  live theatre lectures. Laboratory practicals will take place over full days over the course of the semester.  Longer lab sessions over a shorter period of time will allow more work to be conducted and and will better simualte a 'real' work environment for the student. This teaching and learning strategy will be augmented by both independent and directed learning strategies. A learning platform (such as moodle) will be used as a repository of educational resources (e.g. journals, online resource information) and also as a means of assessment (e.g. quizzes, uploading of assignments etc.).

 

 

Module Assessment Strategies

This module will be assessed using a combination of end of semester final exam (50%) and continuous assessment (50%). Laboratory skills, report-writing and critical analysis of results will be assessed as part of the continuous assessment aspect of this module which will be examined through the submission of  two lab reports and practical evaluation elements. The final exam will offer students the opportunity to communicate their knowledge and understanding of the module content during a closed book exam. Self assessment tests and other forms of formative assessment will be provided to students to check their own progress towards achieving the learning outcomes of the module and to motivate learning. This approach is expected to address student learning needs. A minimum of 75% attendance at laboratory sessions is required. The student must reach an assigned gate (mark) in the final exam and achieve 40% overall to pass the subject.

Repeat Assessments

Reassessment of this module will consist of continuous assessment(s) and/or repeat final exam.

Indicative Syllabus

Identify and evaluate key factors involved in the design of a typical downstream process for biopharmaceuticals.

  • Harvesting of cells
  • Disruption of cells
  • Product isolation
  • Advancements in downstream bioprocessing

Analyse the theory and evaluate key factors involved in chromatography selection for downstream processing applications.

  • Gel filtration
  • Ion-exchange (AEX and CEX)
  • Hydrophobic interaction
  • Affinity-chromatography

Interpret and explain filtration systems for recovery, concentration and viral clearance applications.

  • Microfiltration
  • Ultrafiltration
  • Tangential flow filtration
  • Diafiltration

Demonstrate a range of knowledge and skill in standard and specialised techniques used in downstream protein capture and purification at both lab and pilot-plant scale of operation. Some of these may include (but not limited too): 

  • Centrifugation for cell separation
  • Chromatography techniques
  • Tangential flow filtration
  • Filter integrity testing 
  • Normalised water flow permeability (NWP) test of a filter
  • Operation of the disc-stack centrifuge
  • Column packing and analysis

Interpret, critically evaluate and effectively communicate results obtained from the various bioprocessing practicals. Some of these may include (but not limited too): 

  • Centrifugation for cell separation
  • Chromatography techniques
  • Tangential flow filtration
  • Filter integrity testing 
  • Normalised water flow permeability (NWP) test of a filter
  • Operation of the disc-stack centrifuge
  • Column packing and analysis

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Practical/Continuous Assessment Practical Practical Evaluation 50 % OnGoing 1,2,3,4,5
2 Self Assessment Formative Closed Book Exam 0 % OnGoing 1,2,3,5
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Terminal Exam Final Exam Closed Book Exam 50 % End of Semester 1,2,3,5
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Practical / Laboratory Science Laboratory Laboratory 2 Weekly 2.00
Lecture Flat Classroom Lecture 2 Weekly 2.00
Independent Learning Not Specified Independent Study 3 Weekly 3.00
Total Full Time Average Weekly Learner Contact Time 4.00 Hours

Required & Recommended Book List

Recommended Reading
2017-07 Fundamentals of Modern Bioprocessing CRC Press
ISBN 1138893293 ISBN-13 9781138893290

Biological drug and vaccine manufacturing has quickly become one of the highest-value fields of bioprocess engineering, and many bioprocess engineers are now finding job opportunities that have traditionally gone to chemical engineers. Fundamentals of Modern Bioprocessing addresses this growing demand. Written by experts well-established in the field, this book connects the principles and applications of bioprocessing engineering to healthcare product manufacturing and expands on areas of opportunity for qualified bioprocess engineers and students. The book is divided into two sections: the first half centers on the engineering fundamentals of bioprocessing; while the second half serves as a handbook offering advice and practical applications. Focused on the fundamental principles at the core of this discipline, this work outlines every facet of design, component selection, and regulatory concerns. It discusses the purpose of bioprocessing (to produce products suitable for human use), describes the manufacturing technologies related to bioprocessing, and explores the rapid expansion of bioprocess engineering applications relevant to health care product manufacturing. It also considers the future of bioprocessing--the use of disposable components (which is the fastest growing area in the field of bioprocessing) to replace traditional stainless steel. In addition, this text: Discusses the many types of genetically modified organisms Outlines laboratory techniques Includes the most recent developments Serves as a reference and contains an extensive bibliography Emphasizes biological manufacturing using recombinant processing, which begins with creating a genetically modified organism using recombinant techniques Fundamentals of Modern Bioprocessing outlines both the principles and applications of bioprocessing engineering related to healthcare product manufacturing. It lays out the basic concepts, definitions, methods and applications of bioprocessing. A single volume comprehensive reference developed to meet the needs of students with a bioprocessing background; it can also be used as a source for professionals in the field.

Recommended Reading
2013-04-29 Biopharmaceuticals John Wiley & Sons
ISBN 9781118687383 ISBN-13 1118687388

The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.

Recommended Reading
2016-04-19 Disposable Bioprocessing Systems CRC Press
ISBN 9781439866955 ISBN-13 1439866953

Because of many misconceptions, the biological drug manufacturing industry does not fully utilize disposable components, despite their wide availability. These misconceptions include concerns for the quality of materials, running costs, scalability, the level of automation possible, and the training of staff needed to include these components in existing bioprocessing systems. Not fully realizing the long-term benefits, many manufacturers are unwilling to discard investments made in fixed equipment and traditional stainless steel systems. Regulatory and environmental concerns, however, will eventually compel manufacturers to adopt disposable systems. Making a strong case for disposables, Disposable Bioprocessing Systems demonstrates the true potential of these systems. Written by a researcher and professor with hands-on experience in designing, establishing, and validating biological manufacturing facilities worldwide, and creating model facilities using maximum disposable technology, this book is the first comprehensive introduction to understanding disposable systems. It gives an overview of the current state of the disposable bioprocessing industry, resolves all controversial issues, and guides readers in choosing disposable components that meet their needs. An important chapter on safety addresses facts and myths about the use of plastics and elastomersincluding the issue of leachingand how to ensure regulatory compliance. Helping readers understand their choices, the book describes the equipment and systems available to prepare the starting materials for the manufacturing of biological drugsfrom disposable containers to filters. The author also discusses costs, regulations, and concerns about waste disposal, and shares his predictions for the future of the disposable bioprocessing industry. A practical manual for those interested in the transition to disposable systems, this book will also interest students of bioprocessing. It offers a timely view of disposable bioprocessing technology as a "game changer" that will facilitate developing new drugs and conducting research in the emerging field of stem cells and gene therapy.

Module Resources

Non ISBN Literary Resources

See book list.

Journal Resources

Relevant, up-to-date peer reviewed publications will be made available via the online learning platform. 

URL Resources

Up to date links will be made available via the online learning platform. 

Other Resources

Relevant, up-to-date resources will be made available via the online learning platform. 

Additional Information

None