This module aims to provide students with a broad understanding of the theory of cell culture processing as it relates to the biosynthesis of modern biopharmaceutical products. It will include a combination of theory and practical laboratory work.

1. Outline the fundamentals of cell biology, cell culture processing and explain the process kinetics relating to cell growth.
2. Describe the various bioreactor designs available and their key features including relative advantages and disadvantages of different operating loops.
3. Describe the main operating cvontrol loops for a modern bioreactor and the critical control parameters associated with bioreactor performance.
4. Perform a range of laboratory and pilot plant practicals relating to cell culture processing.
5. Communicate scientific information and data in an appropriate format.

This module aims to provide students with a good understanding of the main support service areas involving both facilities and utilities that underpin the modern biopharmaceutical manufacturing industry.

1. To provide an explanation of the technical and managerial challenges associated with the design and construction of a biopharmaceutical manufacturing facility.

2. To appreciate the major elements of these projects from site master planning through conceptual and detailed design and onto commissioning and qualification.

3. To address the operational requirementsfor the manufacturing facility within an overall design.

4. To explain key concepts incorporated into cleanroom design and classification.

5. Describe the key principles involved in cleaning and sterilisation including CIP and SIP systems.

6. To understand the key elements of treatment and purification plant used to prepare water fit for bioprocessing operations.

This course aims to provide students with a broad understanding and practical appreciation of the main theoretical concepts and principles of protein purification (downstream processing). This will include both theory some relevant laboratory practicals.

1. Outline the main elements of a downstream process design for protein capture and purification.
2. Describe the general theory and main principles of chromatography technology for protein purification applications.
3. Describe the general theroy and main principles of filtration technology for protein purification applications.
4. Describe the various viral exclusion and elimination technologies for downstream processing.
5. Perform a range of laboratory and pilot plant practicals relating to protein purification.
6. Communicate scientific information and data in an appropriate format and manner.

This module aims to provide students with an understanding of the main considerations in the formulation and fill finish of a biopharmaceutical drug.

1. Describe the key principles of aseptic processing as they relate to drug fill-finish operations.
2. Compare and contrast routes of delivery for biopharmaceuticals (e.g. pulmonary, parenteral, transdermal).
3. Describe the main filling and closure technologies and their control and operation.
4. Explain the principles and applications of freeze-drying technology.
5. Outline the typical quality control measures required for a fill-finish operation.