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BIOT09005 202300
Immunobiologics
Full Title Immunobiologics

Status Uploaded to Banner Start Term 202300

NFQ Level 09 ECTS Credits 05

Contains Must
Attendance N/A % No
Pass Element

Module Code BIOT09005 Duration Semester - (15 Weeks)

Grading Mode Numeric/Percentage Department Pharmaceutical Sci & Biotech

Module Author Dr Anne Mulvihill

Co Authors Dr Siobhan Kavanagh

Module Description

The introduction of immunobiologics revolutionised clinical outcomes for certain conditions, and the prominence of
monoclonal antibodies as therapeutic agents means that many biopharmaceutical companies have multiple antibodies in
their development pipeline. This module will provide the learner with a comprehensive knowledge of the relevance of
immunobiologics as protein therapeutics, including detail on their development, toxicity, and regulation, and the evolution of
biosimilars. It will also explore more novel immune based therapeutics including cells and nucleic acids, to highlight the ever
expanding potential of the immune system in disease treatment and prevention.

 Learning Outcomes on completion of this module the learner will/should be able to;

1. Look at the immune system and its components, and identify potential immunobiologics and also targets.

2. Analyse the development of immunobiologics and biosimilars, highlighting regulation of these products.

3. Explore the potential of immunobiologics beyond mAbs and cytokines, including novel vaccination and cell therapies.

4. Evaluate the relationship between clinical efficacy and toxicity in administration of immunobiologics.
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Indicative Syllabus

Immunobiologics
Definition and characteristics
Age of biopharmaceuticals – history, current status, future prospects;
Discovery and development of immunobiologics as protein therapeutics

Review the principles of Immunobiology

Cellular and molecular components of the immune system, including dendritic cells, T cells, and antibodies
Antigens and epitopes, immunogenicity,
Antibodies

Polyclonal and monoclonal

Monoclonal antibodies – development, structure, characteristics, mechanism of action –e.g Enbrel, Herceptin, and the
more novel, including their clinical applications
Production methods, recovery and purification process development for monoclonal antibody production, problem
solving
Bi-specific, drug-conjugate and Fc-fusion proteins
Technical limitations to mAb production
heterogeneity, aggregates, fragmentation
stabilisation, impurities
Immunogenicity and Immunotoxicity
ADME, HAMA response
pharmacokinetics, toxicokinetics

Biosimilars

follow-on biologics
development
regulation
Case Studies - established and current examples
Vaccines

Traditional and contemporary vaccine design

Guidelines/Directives

Cell Therapies
CAR- T, dendritic, NK cells

Teaching and Learning Strategy

The teaching and learning strategy will comprise of traditional lectures with an emphasis on linking theory to current
research/developments in the field. Significant class time will be dedicated to group discussion and interpretation of relevant
literature thereby facilitating and supporting students to become independent self-evaluative learners.
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Assessment Strategy

A learner must achieve a cumulative score mark of 40% for the module.

The assessment strategy for this module will include an end of module written examination which will act as a summative
assessment of the student’s knowledge of theoretical aspects of immunobiologics, their development, production and
regulation.

Students will also be formatively assessed throughout the module by engaging with relevant literature and case studies with
follow-up class critique, Q & A session thereby providing students with feedback on their knowledge and maximising the
likelihood of achieving the module learning outcomes.

There will be a cross-modular assessment undertaken with the Methods in Biopharmaceutical Manufacture module. It will
allow the students to utilise the information from lectures combined with their own reading/self-directed learning to evaluate
immunobiologics and particular the methods employed to develop/produce such biopharma products.

Repeat Assessment Strategies

If a student does not achieve a cumulative grade of 40% the failed component must be repeated at the next available
sitting.
Failed Exam or Failed CA will be repeated/submitted in the Autumn repeat session.

Repeat assessments will be in line with the original assessment and assess the learning outcomes that were not achieved.

Indicative Coursework and Continuous Assessment: 20 %

Must Week Learning

Type Form Title Percent
Pass (Indicative) Outcomes

Presentation - Cross-modular
Continuous
Assessment Assessment with 'Methods in..' 20 % No OnGoing 2
Assessment
module

End of Semester / Year Formal Exam: 80 %

Week Learning
Type Form Title Percent
(Indicative) Outcomes

Closed Book
Final Exam End of Semester written exam 80 % End of Semester 1,2,3,4
Exam

Full Time Average Weekly Workload: 2.00 Hours

Type Description Location Hours Frequency Weekly Avg

Lecture Lecture Lecture Theatre 2 Weekly 2.00

Independent
Independent Learning Not Specified 7 Weekly 7.00
Learning

Recommended Reading Book List

Shargel, L., (2012). Applied Biopharmaceutics & Pharmacokinetics, Sixth Edition. McGraw-Hill Medical.
ISBN 007160393X ISBN-13 9780071603935

Ramzan, I., (2021). Biologics, Biosimilars, and Biobetters. John Wiley & Sons.
ISBN 9781119564669 ISBN-13 1119564662

Liu, C., John, K., (2016). Biosimilars of Monoclonal Antibodies. John Wiley & Sons.
ISBN 9781118940624 ISBN-13 1118940628
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Andrew, M., (2021). Cellular and Molecular Immunology. 10th Edition. Elsevier.
ISBN 0323757480 ISBN-13 9780323757485

(2013). Human Monoclonal Antibodies: Methods and Protocols (Methods in Molecular Biology). Springer.
ISBN 1627035850 ISBN-13 9781627035859

Shire, S., (2015). Monoclonal Antibodies: Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of
Final Drug Product. Woodhead Publishing.

Marks, V., (2015). The Lock and Key of Medicine: Monoclonal Antibodies and the Transformation of Healthcare. Yale
University Press.

Non ISBN Literary Resources

Google books

TUS Midlands Library - books and online resources including ebooks

Journal Resources

mAbs
Antibody Journal

Biologics and Biosimilars A section of Pharmaceutics (ISSN 1999-4923).

GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Immunology

Vaccines - various

Online Resources

https://www.ncbi.nlm.nih.gov/pubmed/
https://www.sciencedirect.com/
https://health.ebsco.com/products/international-pharmaceutical-abstracts

tabs.craic.com (Therapeutic antibody database)

https://www.ich.org
https://www.edqm.eu

https://www.fda.gov
https://www.biophorum.com
www.ema.europa.eu

https://www.antibodysociety.org/web-resources/

Other Resources
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Nature Immunology

Nature Protocols :Immunological Techniques

Journal of Immunobiology
Journal of drug development and research

Journal of Drug Metabolism and Toxicology

Biologics
BioPharm International

Programme Membership

AL_SBIOP_9 202300 Master of Science in Biopharmaceutical Technology

AL_SBIOP_9X 202300 Postgraduate Diploma in Science in Biopharmaceutical Technology (Exit)