UCC College Calendar

Note: Every effort has been made to ensure that the programme and module content as described in the University's Calendar and Book of Modules for the 2020-21 academic year are accurate. However, due to the Coronavirus (COVID-19) pandemic, no guarantee is given that programme/module content, delivery and assessment may not be altered, cancelled, replaced, augmented or otherwise amended. Any changes will ensure the same competencies and Learning Outcomes are met. Programme and/or Module Coordinators will communicate any such changes to students.

General

The Higher Diploma in Design and Manufacture of BioPharmaceuticals is a full-time programme taken over 12 months (September-August).

Entry Requirements

Applicants must have a Second Class Honours Grade II in Honours Primary (NFQ, Level 8), in any discipline.
A quota will be allocated to applicants who do not meet these entry requirements. These applicants will be considered under RPL and assessed on the following factors:

• Academic achievement
• Prior Work Experience
• Letter of Reference
• Personal Statement

Programme Requirements

Students take 60 credits as follows:

BC5004 Introduction to Human Molecular and Cellular Biochemistry (10 credits)
BC5005 SkillsBET-BioPharma (Skills Based Education and Training in BioPharmaceutical Sciences) (5 credits)
BC5006 Technical and Professional Skills Training for Employment in the BioPharma Workplace (15 credits)
PE5004 Introduction to BioPharmaceutical Process Engineering (5 credits)
PF5001 Introduction to Pharmaceutical Process Design and Verification (5 credits)
PF5002 Biological Drug Manufacture: Introduction to Regulatory and Sterility Requirements (10 credits)
PF5003 Introduction to BioPharmaceutical Technologies and Processes (10 credits)

Module Semester Information may be found here. Module here.
Examinations
Full details and regulations governing Examinations for each programme will be contained in the Marks and Standards 2020/2021 Book and for each module in the Book of Modules, 2020/2021.

Programme Learning Outcomes

Programme Learning Outcomes for Higher Diploma in Design and Manufacture of BioPharmaceuticals (NFQ Level 8, Major Award)
On successful completion of this programme, students should be able to:

Describe the fundamental principles of biochemistry and cell biology as they relate to health and disease
Explain the development and design of major classes of biological drugs
Describe an understanding Process Engineering principles as they relate to the production of BioPharmaceuticals
Assess the key parameters to be considered in upstream processing, downstream processing and the formulation of biological drugs
Describe the key concepts and principles of quality standards and regulations (eg. current Good Manufacturing Practices, cGMP) and their integration in the production of a sterile BioPharmaceutical products.
Demonstrate competence in the laboratory-scale production of a biological protein drug in accordance with written Standard Operating Procedures (SOP's).
Design, implement and evaluate scientific investigations and assess, interpret and understand experimental data generated.
Recognise and articulate personal and professional skills in the context of career planning, and demonstrate an ability to write an effective application.