This module examines all 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 Lean tools such as Value Stream Mapping, SMED, 5S, Visual Management, TPM, Kaizen Events, Creating Continuous Flow.
4. Demonstrate the application of Six Sigma tools such as DMAIC, Process Centering and Variation Reduction, SPC, PCA, QFD, FMEA, Poka-Yoke, HACCP, ANOM, ANOVA.
5. For a typical manufacturing operation demonstrate the application of a combination of Lean-Sigma tools.

This module aims to provide learners with a deep understanding of the theory of mammalian cell culture processing as it pertains to the biosynthesis of modern biopharmaceutical products. It will examine the processing flow from cell vial thaw and subsequent scale-up through to protein synthesis and product formation. Consideration will be given to the development and characterisation of cell lines for use in biomanufacturing, the kinetics of cell growth and media requirements to optimise cell performance and productivity. The learner will be exposed to a detailed comparative discussion of mammalian cell bioreactor design, operation, and control for the successful manufacture of biotherapeutic proteins.

1. Describe the fundamentals of mammalian cell biology and cell line development and explain the process kinetics relating to cell growth and productivity for a bioreactor process.

2. Identify the key components of mammalian cell culture media formulations and relate those to the optimisation of a cell culture process.

3. Compare and contrast the most common bioreactor designs available, their key features and the relative advantages and disadvantages in different operating modes.

4. Describe the key steps in bioreactor operation, the critical control parameters and the main operating and control loops associated with bioreactor performance monitoring.

5. Analyse, evaluate and draw conclusions from data obtained from lab. demonstrations and/or data obtained from problem solving exercises.

6. Perform research on a relevant topic and communicate in writing and orally an informed and evidence based analysis and evaluation of current thinking, with appropriate conclusions.

This module addresses ICH legislation for biopharmaceutical processing. It also introduces GMP, environmental and health and safety legislation relevant to the biopharmaceutical industry.

1. Demonstrate abroad-based knowledge and understanding of the main US and EU institutions, legal instruments, ICH process and workings of EMEA.
2. Evaluate applicability of current environmental, health and safety legislation for biopharmaceutical industry.
3. Source and evaluate procedures and directives currently regulating good manufacturing practices (GMP).
4. Integrate knowledge and understanding of CTD, variations procedures and Clinical Trial Legislation to evaluate relevant case studies.
5. Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.
6. Communicate and explain scientific data relating to quality systems and regulatory affairs.

This module aims to provide the learner with a deep understanding of the key theoretical concepts and principles of protein purification (downstream processing) as part of biotherapeutic protein manufacturing. The module will address all key steps in downstream processing from product recovery using different filtration techniques and/or centrifugation, to protein product capture, purification and polishing using various chromatographic techniques, and viral clearance. Consideration will be given to the selection of chromatographic methods, their operation, process scale-up and evaluation of column performance. Sources of viral loads from cell culture and other avenues will be discussed including techniques for their elimination.

1. Outline the main elements of an effective and efficient downstream process design for protein capture and purification.
2. Explain downstream processing technologies such as microfiltration, ultrafiltration, diafiltration, and centrifugation.

3. Discuss the general theory and principles of chromatography technology for protein purification applications and the application of this theory to evaluating column performance.

4. Compare and contrast the different types and modes of chromatography used in downstream processing.

5. Describe the various viral exclusion and elimination technologies for downstream processing as well as relevant quality control methods.

6. Perform research on a relevant topic and communicate in writing and orally an informed and evidence based analysis and evaluation of current thinking, with appropriate conclusions.

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

1. Describe the key elements in a systematic approach to validation with particular emphasis on their application to bioprocessing.
2. Understand and apply the key elements of equipment qualification and analytical test method validation

3. Evaluate the main steps involved in the process validation of the biopharmaceutical manufacture upstream process (cell culture processing).

4. Evaluatethe main steps involved in the process validation of the biopharmaceutical manufacture downstream process (protein purification).

5. Describe the validation approach for viral control technologies for biopharmaceutical manufacture.
6. Communicate and explain scientific data relating to biopharmaceutical validation.

This module aims to provide students with a detailed knowledge and understanding of the various analytical assays routinely employed in the analysis of critical quality attributes (CQAs) of biopharmaceuticals. These analytical assays are used to assess the raw material, in-process, bulk drug substance and finished product quality attributes.

1. Outline and evaluate the various assays/tests methods and instrumentation routinely employed in the analysis of Biopharmaceuticals.
2. Formulate and communicate judgements with regard to the complexities and challenges in the analysis of biologics.
3. Analyse, evaluate and draw conclusions from data presented in problem solving exercises.
4. Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.
5. Communicate and explain scientific data relating to bioanalytics.