This course will provide the student with a broad knowledge, understanding and appreciation of the principal features and aspects of a modern biomedical manufacturing or services related environment.

1. Outlinehow a modern biopharmaceutical/biomedical/med tech manufacturing industryoperates,and demonstrate understanding ofthe regulatory requirements of these industries.

2. Adapt and apply knowledge and skills acquired in the educational environment to the industrial, services or other scientific related work environment.
3. Analyse and critiquescientific information/data relating to the industrialworking environments in both a team-based and professional report format.

4. Propose and defend solutions to real/simulated complexworkplace problems.
5. Differentiate personal roles and responsibilitesfrom that of the team’s during professional problem solving activities.

The objective of this module is to introduce students to the recombinant drug discovery and development process. This module encompasses key steps in recombinant cell engineering and production including vector design and manipulation, gene delivery and expression, model system choice and expression detection. The module will further investigate approaches to enhancing recombinant protein expression and functionality. Concepts and methodologies uniquely associated with recombinant antibodies will be addressed. The module will also introduce gene-editing technologies and their role in future therapeutics.

1. Align the concept of rational drug design with recombinant protein production and identify the key tools required in the process.

2. Assess the essential steps in the design, cloning and control of a recombinant expression systems.

3. Describe methods employed to optimise nucleic acid sequences and cell expression systems for optimum protein expression.

4. Examine methods of verifying the function and expression recombinant genes and gene products and verify the role of the gene/drug target in the disease process.

5. Plan, design and execute laboratory protocols which are used to develop genetically modified cells.

6. Analyse and report experimental concepts and data.

This module aims to provide the student with a broad understanding of both the theory and practical aspects of cell culture processing as it pertains to the biosynthesis of modern biopharmaceutical products. It will deal with the processing flow from cell vial thaw and subsequent scale-up through to protein synthesis and product capture.

1. Describe the basics of cell biology and the process kinetics relating to cell growth and productivity for a bioreactor process.
2. Explain the different types and formulations of media available and their overall importance in optimising the cell culture process.
3. Utilising a selected cell line perform the scale-up process for bioreactor inoculation and describe the main steps involved and their function.
4. Perform cell counting techniques utilising appropriate technologyto verify cell density performance during bioreactor operation.
5. Describe the various bioreactor designs available and their key features including relative advantages and disadvantages of different operating modes.
6. Operate a bioreactor and control the variouskey parameters to demonstrate the impact on protein synthesis and biomass performance.

7. Perform a cell / proteinharvesting steputilisingeither filtration orchromatography technologies.

8. Report written laboratory work to an industry standard, including data interpretation and statistical analysis.

Medical diagnostics module is concerned with the use of molecular biomarkers for the detection, diagnosis, prognosis and treatment of disease. Current biomarkers and technologies are discussed and new high-throughput methods and approaches for identification of new markers are described, some of these include microarray analysis, metabolomics and epigenetics. The module discusses the importance of these biomarkers in terms of survival, prognosis and personalised healthcare. The module introduces the concept and role of point of care testing in a modern healthcare environment.

1. Examine current examples of biomarker use in diagnostics.

2. Describe array-based, metabolomic and epigenetic methodologies for identification of biomarkers.

3. Appraise clinical data used for the analysis and discovery of disease markers and their application in clinical tests.

4. Illustrate the use of biosensors in the point of care analysis and monitoring of disease.

5. Execute experiments and methods used to identify molecular targets.

6. Analyse and present experimental data relating to biomarker discovery.

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 highlight and evaluate the various risks inherent in bioprocessing 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 thekey elements of equipment qualification and analytical test method validation.

3. Categorisethe principal risks associated with the manufacture of modern biopharmaceuticals and tools to evaluate them

4. Evaluate the main steps involved in the process validation of upstream (cell culture processing) and downstream (protein purification) processes.

5. Explain the validation approaches for cleaning, sterilisation andviral control technologies in the manufacture of biopharmaceuticals.

6. Communicate and explain scientific data relating to biopharmaceutical validation.

This course aims to provide the student with a broad understanding of the main theory and practical aspects of protein purification (downstream processing) from product capture at the end of the cell culture process through the various stages of protein separation and purification including viral elimination.

1. Outline the main elements of an effective and efficientdownstream process designfor protein capture and purification application from DPC (direct product capture) to BDS (bulk drug substance).

2. Describe the general theory and main principlesof chromatography technology for protein purification applications.

3. Perform a protein capture step utilising ion exchange chromatographyinvolving a suitablematrix resin.

4. Outline and differentiate between the different types of chromatography systems in use for protein purification purposes.
5. Explain other potential downstream processing technologies such as microfiltration, ultrafiltration, diafiltration, centrifugation.
6. Operate the various forms of filtration technology available for purification purposes – normal flow filtration (microfiltration, ultrafiltration), tangential flow filtration, diafiltration etc.
7. Describe the various viral exclusion and elimination technologies available for downstream processing as well as relevant quality control challenges.
8. Report laboratory work to an industry standard, including effective data interpretation and statistical analysis.

This course is designed to provide specialised knowledge in the theory, practice and interpretation of the various assays and instrumentation routinely employed in a routine biologics quality control (QC) testing laboratory. This course guides students through the core analytical methods and platforms routinely employed in a QC testing laboratory. The necessary skills and competencies will be acquired through a combination of lectures, hands‑on practical training and demonstrations plus self‑study. The course will cover methods such as spectroscopic, chromatographic, electrophoretic and mass spectrometric approaches for the analysis of biological drugs plus new and emerging technologies as they arise.

1. Outline and evaluate the main QC test methods and bioanalytical instrumentation routinely employed in the analysis of biologics by sourcing and interpreting the theory behind the methods.

2. Perform a range of analysis and interpret and critically evaluate the data obtained from practicals and demonstrations and solve/troubleshoot analytical problems.

3. Develop professional practice skills includingscientific writing report writingand oral communication skills.

The aim of this module is to provide students with an understanding of the main considerations in the formulation of a biopharmaceutical drug. The module will introduce students to the challenges encountered in the formulation of biopharmaceutical products. They will gain an understanding of the key steps in preformulation, formulation, lyophilisation and fill-finish operations. This module will also address current and emerging drug delivery systems for therapeutic peptides, proteins and nucleic acid based drugs.

1. Formulate and communicate judgements with regard to challenges encounteredin the formulation of biopharmaceuticals.

2. Describe the fundamental objectives of preformulation.

3. Evaluate the use of different excipients in formulation, and outline the primary stages of sterile fill-finish operations.

4. Explain the principles and applications of freeze-drying technology.
5. Compare routes of delivery for biopharmaceuticals and evaluate current and novel drug delivery systems designed for biopharmaceuticals.

The aim of this module is to develop the student's ability to independently apply the knowledge, skills and competences they have acquired in the course, in the planning and completion of a final year project. The project may be team based including team skills or the course of study may be on an individual platform.

1. Have the ability to plan and organise activities within the time frame of the project.
2. Complete and present (written and orally) a comprehensive literature survey and present a report on the results of their study.
3. Enhance their ability to work and study with minimum supervision.
4. Have applied analytical knowledge and practical skills gained during the course to solve an analytical problem.
5. Have gained experience in experimental design, and the selection of techniques and methods applicable to analytical problem solving.
6. Be capable of analysing data produced in the study and write a final dissertation.
7. Develop their research skills and abilities.
8. Enhance their communication skills through presentations, report writing and defence of their research findings.