Module Code - Title:

BC4718 - INDUSTRIAL BIOCHEMISTRY 2

Year Last Offered:

2025/6

Hours Per Week:

Lecture

2

Lab

0

Tutorial

1

Other

2

Private

5

Credits

6

Grading Type:

N

Prerequisite Modules:

BC4904

BC4905

BC4903

Rationale and Purpose of the Module:

To present an overview of (a) animal cell culture and (b) pharmaceutical biotechnology in the context of underlining science and industrial/medical applications. To provide the scope for a measure of student self-directed learning and problem-based learning.

Syllabus:

Animal cell culture; Overview and introduction to animal cell culture. Animal cell culture, media, methods and apparatus. Animal cell culture; production of industrially useful products. The drug development process; Regulatory route for new drugs in USA & EU. Biopharmaceutical manufacture; Sources of biopharmaceuticals. Upstream processing. Downstream processing. Post translational modifications and their significance. Product QC and the range and significance of potential product impurities. Biosimilars. Monoclonal antibody - based biopharmaceuticals. Nucleic acid-based biopharmaceuticals.

Learning Outcomes:

Cognitive (Knowledge, Understanding, Application, Analysis, Evaluation, Synthesis)

On successful completion of this module, students will be able to: 1. Describe the concepts and processes underpinning the development and manufacture of products of pharmaceutical biotechnology 2. Independently identify and evaluate pertinent information from scientific and additional literature sources. 3. Critique suggested product development approaches or production schemes with a view to assessing their industrial suitability 4. Devise product development or production schemes appropriate for purpose

Affective (Attitudes and Values)

1. Display an awareness of the potential impacts of gene therapy on society.

Psychomotor (Physical Skills)

none

How the Module will be Taught and what will be the Learning Experiences of the Students:

Module will be taught via a combination of formal interactive lectures, pursuit of problem and project-based learning, as well as case-studies. This combination will underpin development of student agility, curiosity and courageousness. The students will also undertake a measure of independent, self-directed learning in the context of sourcing and considering information relating to 2-3 specific biopharmaceutical themes. The students will also undertake a written, problem based project, contributing to the development of articulate graduates. The self directed learning and project assignment elements require the students to independently identify, evaluate and apply recent research and industrial developments in the field to specific tasks or problems. The module will be assessed by means of a final written exam and/or assignment.

Research Findings Incorporated in to the Syllabus (If Relevant):

Prime Texts:

Walsh, G. and Walsh, E. (2022) Biopharmaceutical benchmarks 2022 , Nature Biotechnology, 4 (12) 1722-1760

Other Relevant Texts:

Stone, C. et al. (2024) Engineering therapeutic monoclonal antibodies , Journal of Allergy and Clinical Immunology, 153 (3) 539-548

Mroczek, D. et al. (2024) obstacles to biosimilar acceptance and uptake in oncology , JAMA Oncology 10 (7) 966-972

Incir, I and Kaplan, O (2024) E. coli in the production of biopharmaceuticals , Biotechnology and applied biochemistry doi.org/10.1002/bab.2664

Chahar, D. et al. (2020) Monoclonal antibody purification and its progression to commercial scale , Biologics, 63, 1-13

Programme(s) in which this Module is Offered:

BSINBIUFA - INDUSTRIAL BIOCHEMISTRY

Semester(s) Module is Offered:

Spring

Module Leader:

Gary.Walsh@ul.ie