Module Code - Title:
BC4705
-
INDUSTRIAL BIOCHEMISTRY 1
Year Last Offered:
2025/6
Hours Per Week:
Grading Type:
N
Prerequisite Modules:
BC4903
BY4013
Rationale and Purpose of the Module:
To present an overview of major practical aspects of pharmaceutical manufacture, quality systems and pertinent environmental regulation. To present an overview of industrial enzymes/proteins and their uses. To facilitate critical analysis of issues/topics pertaining to these themes and to provide scope for a measure of student self-directed learning.
Syllabus:
Practical Aspects of Pharmaceutical Manufacture: International Pharmacopoeia. GMP in the Pharmaceutical Industry. The Pharmaceutical Facility; Clean Rooms, Cleaning Decontamination and Sanitation. Generation of Water for Pharmaceutical/ Biopharmaceutical Processing. Product Flow Through the Facility and Associated Documentation. The ISO series of quality standards. Laboratory accreditation. Validation of methodology and industrial processes in biotechnology. Environment and Industry, the Environmental Protection Agency (EPA) and IPPC Licensing for biotechnology. Industrial enzymes and proteins; range, applications and selected case studies. Stabilizing proteins for industrial use.
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 practical industrial aspects of pharmaceutical manufacture, quality systems, validation and IPPC licensing.
2. Describe the range and applications of industrial enzymes/proteins.
3. Independently identify and evaluate pertinent information from scientific and additional literature sources.
4. Devise or critique selected production, quality, validation or environmental regulatory schemes/approaches appropriate for purpose.
5. Describe the range and application of industrial enzymes and other proteins.
6. Propose or evaluate the physicochemical properties of enzymes/proteins in the context of potential industrial application.
Affective (Attitudes and Values)
On successful completion of this module, students will be able to:
1. Demonstrate an appreciation of the potential effects of biotechnological manufacturing activity upon the environment.
Psychomotor (Physical Skills)
N/A
How the Module will be Taught and what will be the Learning Experiences of the Students:
Module will be taught primarily through a formal interactive lecturing mode. The students will also undertake a measure of self-directed learning in the context of sourcing, evaluating and applying information relating to the syllabus.
Research Findings Incorporated in to the Syllabus (If Relevant):
Prime Texts:
Walsh, G. (2002)
Proteins. Biochemistry and Biotechnology.
, John Wiley
Walsh, G. (2013)
Biopharmaceuticals, Biochemistry and Biotechnology.
, John Wiley
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Students will be expected to source additional reading materials from various regulatory authority websites, as well as from literature databases such as the web of knowledge.
,
Other Relevant Texts:
Programme(s) in which this Module is Offered:
BSINBIUFA - INDUSTRIAL BIOCHEMISTRY
Semester(s) Module is Offered:
Autumn
Module Leader:
Gary.Walsh@ul.ie