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 the main stages involved in a systematic approach to the validation of 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 organisms for 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.