VALD09007 2019 Biologics Manufacturing

General Details

Full Title
Biologics Manufacturing
Transcript Title
Biologics Manufacturing
Code
VALD09007
Attendance
N/A %
Subject Area
VALD - Validation
Department
LIFE - Life Sciences
Level
09 - NFQ 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)
Mary Butler, Colin Fowley
Programme Membership
SG_SBCQV_E09 201900 Level 9 Certificate in Science in CQV Commissioning, Qualification and Validation for Biologics Manufacturing
Description

This module examines all aspects of a typical biopharmaceutical production process. The primary focus of the module will be on the main operations involved in the production, purification and aseptic filling of a biologic drug product. Key topics covered throughout the module include upstream, downstream and formulation/fill finish manufacturing processes, with a focus on the main unit operations involved in each of these areas.

Learning Outcomes

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

1.

Appraise the key features that are involved in the design of an upstream bioprocessing operation, including cell line choice, cell banking and cell culture scale-up. Interpret regulatory requirements for manufacturing biopharmaceutical drug products produced by aseptic processing.

2.

Critically evaluate the various bioreactor designs available for production, and their key features, including the advantages and disadvantages of each.

3.

Debate the main aspects of bioreactor control and operation, including the key instrumentation types found on the systems.

4.

Recognise and describe the design features that should be considered for the effective purification of a biopharmaceutical drug product. Evaluate the different chromatography techniques available for purification and their modes of operation, including the advantages and disadvantages of each.

5.

Critically evaluate the different chromatography techniques available for purification and their modes of operation, including the advantages and disadvantages of each.

6.

Outline the use of other purification technologies used in downstream processing including ultrafiltration diafiltration, viral inactivation and viral clearance. Explain the principal methods of filling biopharmaceutical drug products aseptically.

Teaching and Learning Strategies

This Module will be delivered part time.

This will include online lectures augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a means of assessment. 

Module Assessment Strategies

This Module is 100% Continuous assessment

 

Repeat Assessments

Repeat continuous assessment in line with marks and standards and the quality manual.

Indicative Syllabus

This module examines all aspects of a typical biopharmaceutical production process. The primary focus of the module will be on the main operations involved in the production, purification and aseptic filling of a biologic drug product. Key topics covered throughout the module include upstream, downstream and formulation/fill finish manufacturing processes, with a focus on the main unit operations involved in each of these areas. Topics covered will include some of the following: cell line selection, cell banking, product scale-up, bioreactor design types, media feeding systems, bioreactor controls, intracellular v’s extracellular proteins, principles of centrifugation and micro-filtration, ultrafiltration, diafiltration, chromatography techniques, viral clearance technologies, aseptic processing, use of isolator and barrier technology, aseptic process simulations and filter integrity testing.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Continuous assessment-1 (20%) will involve a short written assignment Continuous Assessment Assignment 20 % Week 4 1,2,3
2 Continuous assessment-2 (20%) will be a live online quiz, long answer question (LAQ) format Continuous Assessment Assessment 20 % Week 8 4,5,6
3 Written project report (50%) Project Project 50 % End of Semester 1,2,3,4,5,6
4 Technical Presentation Continuous Assessment Individual Project 10 % End of Semester 1,2,3,4,5,6

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Not Specified Lecture 2 Weekly 2.00
Independent Learning Online Self Study 6 Weekly 6.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Required Reading
1997-12-05 Pharmaceutical Biotechnology CRC Press
ISBN 9057022486 ISBN-13 9789057022487

The first target group for this book is the pharmacists who wish to update their knowledge of biotechnology. A second target group is the present generation of pharmacy students at our universities; and thirdly, the pharmaceutical scientist who has not been in contact with modern biotechnology and wishes to familiarize him or herself with the principles of this fast moving field. Therefore, we hope that this book will be used at universities, in life-long learning courses, and in the professional environment of the pharmacist and industrial pharmaceutical scientist all over the world. For educational purposes, each chapter is concluded with a number of self-assessment questions and a number of literature references for further reading. The multicolor printing of the artwork in this book should assist the reader in mastering the contents of this book.

Required Reading
2013-04-25 Pharmaceutical Biotechnology John Wiley & Sons
ISBN 9781118685754 ISBN-13 111868575X

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific product category chapters focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

Module Resources

Non ISBN Literary Resources
  • BioPhorum Operations Group: Biomanufacturing Technology Roadmap.

 

  • Downstream processing of monoclonal antibodies—Application of platform approaches Abhinav A. Shukla, Brian Hubbard, Tim Tressel, Sam Guhan, Duncan Low.

 

  • Deloitte: Advanced Biopharmaceutical Manufacturing: An Evolution Underway. 2015

 

  • Single-use in the biopharmaceutical industry: A review of current technology impact, challenges and limitations. Adriana G. Lopes
URL Resources
Other Resources
  • BioPhorum Operations Group: Biomanufacturing Technology Roadmap.

 

  • Downstream processing of monoclonal antibodies—Application of platform approaches Abhinav A. Shukla, Brian Hubbard, Tim Tressel, Sam Guhan, Duncan Low.

 

  • Deloitte: Advanced Biopharmaceutical Manufacturing: An Evolution Underway. 2015

 

  • Single-use in the biopharmaceutical industry: A review of current technology impact, challenges and limitations. Adriana G. Lopes
Additional Information

None