Full Title:Biopharmaceutical Therapeutics
Language of Instruction:English
Module Code:PHAR S8016
 
Credits: 7.5
Valid From:Semester 1 - 2018/19 ( September 2018 )
Module Delivered in 4 programme(s)
Module Description:The aim of this module is to provide students with knowledge of the range and scope of traditional pharmaceuticals of biological origin, and of the underpinning scientific principles and procedures involved in their development, production and biological effect.
Learning Outcomes:
On successful completion of this module the learner should be able to
  1. Compare the key differences between traditional pharmaceuticals of biological origin, synthetic pharmaceuticals and modern recombinant biopharmaceuticals/biosimilars.
  2. Grasp the mechanism of action of common and emerging biotherapeutics.
  3. Explain the development and production of a selected range of biological products.
  4. Assimilate the concept of the biological effects of biotherapeutics through receptor binding and internal cell signalling processes.
  5. Create and communicate formal mini-project reports on biotherapeutic based applications.
 

Module Content & Assessment

Indicative Content
CONTENT
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• Introduction / Historical perspective
What is a Biopharmaceutical?: Chemical (synthetic) versus traditional biological products versus biopharmaceutical . The early use of biological extracts in medicine, the development of immunisation. A brief survey of traditional pharmaceuticals of biological origin and of the sources, production and medical applications of modern therapeutic substances extracted from non-recombinant biological sources (e.g. plant derived pharmaceuticals). The impact of recombinant DNA technology and expression systems pharmaceutical biotechnology. Chinese Hamster Ovary cells – the current leader. Biopharmaceuticals and general safety issues. The impact of biosimilars.
• Cytokines as biotherapeutics
Chemical messenger overview. Focus on the two families of Interleukins (IL-2 in particular) and Interferons as biopharmaceuticals. Focus on the cytokine molecules themselves, their receptors, the signalling pathways employed (e.g. JAK-STAT) and the biological effect involved. Mechanisms of cytokine inhibition will also be considered.
• Growth Factors and their value as biopharmaceuticals.
General overview of the growth factor families; Insulin like growth factors, haematopoietic growth factors (e.g Erythropoietin), epidermal growth factors, platelet-derived growth factors etc. and their role in the recombinant biopharmaceutical industry. Primary focus on erythropoietin (production, mechanism of action, glycosylation etc.)
• Therapeutic use of Antibodies
A brief review of immunology. Overview of the clinical applications of monoclonal antibodies; passive immunisation, diagnostic imaging and therapeutic applications. Tumour associated antigens and antibody-based strategies for tumour detection/destruction. Selected examples of monoclonal antibodies approved for medical use. The use of monoclonal antibodies as probes. Polyclonal antibody preparations: production of antisera and purified immunoglobulins. Applications in passive immunisation. Anti-inflammatory treatments. Radio-immuno conjugation, toxin-immuno conjugation and enzyme-immuno conjugation play critical roles in targeted therapies. The selection of the conjugate is critical depending on the target. The generation and mechanism of actions of these compounds will be discussed in detail.
• Hormones
A brief revision of the main hormone systems of the human body. Biochemistry, production and medical applications of selected proteinaceous hormones. Overview of the metabolic synthesis, general biochemistry and therapeutic applications of peptide regulatory factors. A similar overview of steroid hormones and also therapeutic analogues; their use in therapy and in contraception. Hormones produced by genetic engineering. Internal Cell Signalling pathways are also covered in detail, looking at phosphorylation, tyrosine kinases, IP3, DAG and G proteins.
• Emerging biological technologies
An introductory review of novel biopharmaceutical products including emerging vaccine technology, cell and nucleic acid based therapies. The principles of manipulating gene expression to inhibit or overexpress genes of interest to induce a therapeutic effect. The use of modern gene therapy to achieve altered gene expression. Overview of areas including stem cell differentiation, anti-inflammatory exosome secretion and modern vaccine design technology. Selected examples of the use of emerging therapeutics in the clinical setting.
LEARNING & TEACHING RESOURCES
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Format of lecture series
Lecture delivery will comprise a range of methodology including on-line movie animations, visual demonstrations, large diagrams for illustration purposes as well as information and slide handouts. Novel methods using smartphone web/app based quizzes will also be utilised. Course material and revision quizzes will be made readily available on a virtual learning environment (VLE) for student access. The combination of these methods will facilitate in re-enforcing the student’s understanding of some of the technical and mechanistic processes involved. Various aligned classroom assessment techniques may also be employed. These may include aspects such as the background knowledge probe, the one minute paper, small group interaction and discussion, question & answer sessions, team presentations to class colleagues, pop-quizzes and open ended questioning. Access to course textbooks will be provided through the DkIT eBook service, which will allow students 24/7 access to suitable reading material. A range of self-assessment, self-reflection and peer learning exercises will be built in to deliveries of both lectures and practical sessions.
Methodology/Practical exercises will be performed to learn the principles of working in the biotherapeutic field.
The following list is designed to serve as a resource of ideas for suitable practicals to illustrate key concepts and techniques. Many of the practicals and associated techniques are applicable to a range of biopharmaceutical products and so have a broad spectrum of merit. 1. Vitamin C determination in fruit/vegetables 2. Determination of the Rh factor using PCR 3. Pregnancy test using an Enzyme Linked Immunosorbent Assay (ELISA) 4. Student designed Enzyme-linked metabolite assay kits. 5. Generation of a recombinant protein drug using E.coli as an inducible expression system. 6. Identification of selected compounds by HPLC. 7. PCR applications in the biopharmaceutical sector.
Formative Assessments
Throughout the semester, students will be provided with formative assessments both in lectures and in laboratory environments.
Virtual Learning Environment (VLE)
All lecture notes will be provided to the students through a VLE. This VLE will also be used for access to helpful YouTube video clips and peer reviewed publications of interest to the course. Students will have 24/7 access to the VLE allowing them to download and study at their own pace and in their own time. Where helpful, screencast and video resources will be made available to the students to download and listen to in their own time. This will facilitate learning and understanding for all students, but in particular the international students.
ASSESSMENT STRATEGY
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Practical/Skills Evaluation
Practical / Skill set tests / Lab mini-project reports. In the practical sessions, students will focus on improving their practical skill set, while also dealing with obtaining and analysing data in addition to drawing conclusions from the data. Students will also perform formative skill set tests (used to maintain and improve their practical skill set) e.g. pipette tests, graph tests, data handling test, data interpretation tests etc.) all generated to assist understanding and improve technique. Students will work on an interactive lab manual, which will contain in-class exercises for review. Group (Peer-assisted learning) work will be encouraged. Technology use will also be encouraged throughout (for example in some cases pre-practical videos and smartphone based quizzes will be used, the use of excel for graphing / trend line generation etc.). The requirement to submit laboratory mini-project reports and perform formative tests is intended to act as serious encouragement for students to focus on the laboratory work. Marks for these reports will be based on students’ ability to record primary data, calculate derivatives from these, display these data, comment on their meaning in the context of the actual experiment and associated theory, and discuss limitations to the experiment and the results obtained.
Continuous Assessment
Students will perform one class test assignment worth 10% of the module. This will assist students in their engagement with course content from the module to date and assist preparations and revision for the final exam.
Assessment Breakdown%
Course Work10.00%
Practical30.00%
End of Module Formal Examination60.00%

Full Time

Course Work
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Continuous Assessment Students will perform one class test assignment worth 10% of the module. This will assist students in their engagement with course content from the module to date and assist preparations and revision for the final exam. 1,2,3,4 10.00 0 0 Week 9 0
No Project
Practical
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Practical/Skills Evaluation Students will participate in weekly laboratory-based practical sessions in which formative assessments will be performed in interactive group settings (e.g. problem based learning, quizzes, protocol review exercises, worksheet completion etc.). Two summative mini-project practical reports will be submitted during the module (each worth 15%). 2,3,5 30.00 0 0 Every Week 0
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Formal Exam End-of-Semester Final Examination 1,2,3,4 60.00 0 0 End-of-Semester 0

DKIT reserves the right to alter the nature and timings of assessment

 

Module Workload & Resources

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture 3 x 1 hour lectures 3.00 Every Week 3.00
Practical 1 x 3 hour lab session 3.00 Every Week 3.00
Directed Reading Notes / Paper / Textbook reading 2.00 Every Week 2.00
Independent Study Self / group study 5.00 Every Week 5.00
Total Weekly Learner Workload 13.00
Total Weekly Contact Hours 6.00
This course has no Part Time workload.
Resources
Recommended Book Resources
  • Walsh, G. 2013, Biopharmaceuticals - Biochemistry and Biotechnology., 2nd Ed., J. Wiley & Sons
  • Harvey Lodish; Arnold Berk, Chris A. Kaiser, Monty Krieger, Anthony Bretscher, Hidde Ploegh, Angelika Amon, Matthew P. Scott 2016, Molecular Cell Biology, 8th Ed., WH Freeman
  • Whitehouse, D. and Rapley, R. 2012, Molecular and Cellular Therapeutics, Wiley-Blackwell
  • Roitt, I.M. 2017, Essential Immunology, 13th Ed., Wiley-Blackwell Science
  • Bernhard Moser, Gordon L. Letts, Kuldeep Neote 2007, Chemokine biology : basic research and clinical application, 1 Ed., Birkhauser
  • Berg, Tymoczko and Stryer. 2015, Biochemistry, 8th Ed., WH Freeman
  • Singh, Manmohan Srivastava, Indresh K. 2011, Development of Vaccines : From Discovery to Clinical Testing, Wiley
  • David Frank (edt) 2012, Signaling Pathways in Cancer Pathogenesis and Therapy, 1 Ed., Springer Verlag
  • Dewick, P. M. 2009, Medicinal Natural Products: A Biosynthetic Approach., 3rd Ed., J. Wiley & Sons
  • Hutton, J.C. & Siddle, K. 1990, Peptide hormone secretion: a practical approach., Oxford University Press
  • Denyer, S. Hodges, N. A., Gorman, S. P. 2011, Hugo and Russell's Pharmaceutical Microbiology., 8th Ed., Blackwell Science
  • Mohammad A. Tabrizi, Gadi G. Bornstein, Scott L. Klakamp (edt) 2012, Development of Antibody-Based Therapeutics, 1 Ed., Springer Verlag
Supplementary Book Resources
  • Michael Butler et al 2011, Comprehensive Biotechnology, 2nd Ed., Elsevier
  • Rodney J.Y. Ho, Milo Gibaldi 2013, Biotechnology and biopharmaceuticals : transforming proteins and genes into drugs, 2nd Ed., Liss (Alan) Inc
  • Rho, J.P. & Louie, S.G. 2003, Handbook of Pharmaceutical Biotechnology., The Haworth Press Inc.
  • Walter Sneader 2006, Drug discovery : a history, John Wiley & Sons Ltd
This module does not have any article/paper resources
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
Dk_NLBIO_8 Bachelor of Science (Honours) in Biopharmaceutical Science (2020) 6 Elective
DK_SAPBI_7 Bachelor of Science in Applied Bioscience (2019) 6 Mandatory
DK_NLBIO_7 Bachelor of Science in Bioscience (2020) 6 Mandatory
DK_NLPHS_7 Bachelor of Science Pharmaceutical Science (2020) 6 Elective