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 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 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.

This module will demonstrate the importance of the systems approach both to quality and manufacturing within the highly regulated biopharmaceutical sector.

1. Evaluate the development and importance of Quality System Standards.
2. Identify the principal requirements of a Quality System.
3. Evaluate the benefits of the ISO 9000:2005 and ISO17025:2005 Quality Systems
4. Illustrate the importance of documentation as required by a Quality System.
5. Discuss the importance of Good Manufacturing Practice in a regulated environment
6. Describe the main contents of a Quality Manual.

This module aims to provide students with a broad knowledge of the theory, practice and interpretation of the various pharmacopoeia tests and instrumentation routinely employed in a Biopharmaceutical Quality Control laboratory to assess the quality of raw materials, intermediate and finished-goods product.

1. Interpret the European Pharamcopoeia and US Pharmacopoeia for QC Testing.

2. Outline and evaluate the basic test methods routinely employed in the analysis of pharmaceutical and biopharmaceutical products.

3. Describe the typical analytical equipment employed for performance of the analytical test methods.
4. Describe the basic principles of Lean Manufacturing as related to laboratory practices.
5. Analyseand draw conclusions from typical quantitative and qualitative data obtained in an analytical laboratory and/or data presented in problem solving exercises.

This module aims to provide students with a broad knowledge of the practice of the various pharmacopoeia test methods and associated laboratory instrumentation routinely employed in a Biopharmaceutical Quality Control laboratory to assess the quality of raw materials, intermediate and finished-goods product.

1. Interpret the European Pharamcopoeia and US Pharmacopoeia for QC Testing.
2. Outline and evaluate the common test methods routinely employed in the analysis of pharmaceutical and biopharmaceutical products.
3. Describe the typical analytical equipment employed for performance of the analytical test methods.
4. Perform a range of analysis lab. experiments and outline and evaluate the equipment requirements for performance of the various test methods.
5. Demonstrate understanding of how to interpret data from both qualitative and quantitative analytical techniques using GLP as would be required in a QC laboratory.
6. Analyse and draw conclusions from typical data obtained in an analytical laboratory and/or data presented in problem solving exercises.

This Biopharma laboratory practical module will provide students with practical knowledge, know-how and skills associated with the monitoring and control of modern biopharmaceutical manufacturing systems. The relevant learning is achieved through the completion of a sequence of laboratory-based and pilot-plant based practical's and experiments using dedicated control system test rigs that are designed to impart the required expertise. There will also be some research project work associated with the laboratory practical's.

1. Demonstrate a range of practical know-how and skills associated with relevant practical lab. control and monitoring systems.
2. Conduct a range of control system experiments based around a dedicated control rig for a modern bioprocessing system.
3. Follow a sequence of control system instructions for the design and operation of bioprocessing control systems.
4. Perform some defined research work related to the practical lab. control system work ; interpret and critically evaluate the data and results obtained from this research work in a report document.
5. Take responsibility for and direct the work of other individuals in a quasi-GMP environment.
6. Demonstrate effective communication skills both orally and in written format.

This module aims to provide the student with a fundamental understanding of the key elements of bioprocess engineering control systems and the key role they play in the processing of modern biopharmaceutical products.

1. Explain the business case and overall critical importance for the design of process control systems in bioprocessing.
2. Outline the main control system components including process controllers, actuators, feedback sensors etc.
3. Explain the operation of a modern PLC system, how the inputs and outputs are connected to it and how a programme is executed from it.
4. Discuss the principal monitoring and control systems in use for biopharmaceutical processes.

5. Explain the role and operation of SCADA (supervisory control and data acquisition) systems for modern bioprocessing.

This module examines various aspects of the application of Lean Processing and Six Sigma principles and tools as they apply to the modern manufacturing environment.

1. Evaluate and discuss the key principles of Lean Manufacturing and their typical applications for manufacturing.
2. Evaluate and discuss the key principles of Six Sigma programmes and their typical applications for manufacturing.
3. Demonstrate the application of typical Lean tools such as Value Stream Mapping, SMED, 5S, Visual Management, TPM, Kaizen Events, Creating Continuous Flow.
4. Demonstrate the application of typical Six Sigma tools such as DMAIC, Process Centering and Variation Reduction, SPC,FMEA, Poka-Yoke, ANOM, ANOVA.

5. For a typical manufacturing operation demonstrate the practical application of a combination of Lean-Sigma tools.

This course aims to provide the student with a general understanding of the various aspects of process and support systems validation for the manufacturing of modern biopharmaceuticals. It will also deal with the various risks inherent in bioprocessing technologies and how the application of effective validation systems and methodologies assists in the control and management of such risks.

1. Describe themain stages involvedin a systematic approach to the validationof bioprocessing systems.
2. Describe the main steps involved in the process validation of biopharmaceutical cell culture processing.
3. Describe the main steps involved in the process validation of biopharmaceutical protein purification and fill-finish operation.
4. Describe the validation approach for viral control technologies for biopharmaceutical manufacture.
5. Perform some research on a relevant topic and analyse, evaluate and draw conclusions accordingly.
6. Communicate and explain scientific data relating to biopharmaceutical validation.

This module aims to provide students with a fundamental knowledge and understanding of the general principles and methods of Biocontamination control; establishing and verifying the formal system for contamination control and associated test methods and requirements; traditional and modern methods of microbial detection; expressing, interpreting and reporting results; training and documentation requirements.

1. Discuss and evaluate the most relevant biocontamination organismsfor the biopharmaceutical industry and the typical sources of each.
2. Identify and discuss appropriate prevention techniques for each contaminant.
3. Establish the theory behind the biocontamination detection test methods available, including traditional and rapid identification testing.
4. Develop and justify an appropriate monitoring regime for a pharmaceutical/biopharmaceutical facility.
5. Perform some research on a relevant topic and analyse, evaluate and draw conclusions accordingly.
6. Communicate and explain scientific data relating to biocontamination control.