This module examines all aspects of a typical biopharmaceutical production process. The primary focus of the module will be on the main operations involved in the production, purification and aseptic filling of a biologic drug product. Key topics covered throughout the module include upstream, downstream and formulation/fill finish manufacturing processes, with a focus on the main unit operations involved in each of these areas.

1. Appraisethe key features that are involved in the design of an upstream bioprocessing operation, including cell line choice, cell banking and cell culture scale-up. Interpret regulatory requirements for manufacturing biopharmaceutical drug products produced by aseptic processing.

2. Critically evaluate the various bioreactor designs available for production, and their key features, including the advantages and disadvantages of each.

3. Debate the main aspects of bioreactor control and operation, including the key instrumentation types found on the systems.

4. Recognise and describethe design features that should be considered for the effective purification of a biopharmaceutical drug product. Evaluate the different chromatography techniques available for purification and their modes of operation, including the advantages and disadvantages of each.

5. Critically evaluate the different chromatography techniques available for purification and their modes of operation, including the advantages and disadvantages of each.

6. Outline the use of other purification technologies used in downstream processing including ultrafiltration diafiltration, viral inactivation and viral clearance. Explain the principal methods of filling biopharmaceutical drug products aseptically.

This module will provide students with an overview of the technical and managerial challenges associated with the design and construction of a biopharmaceutical manufacturing facility. It will address all the major elements of these projects from site master planning through conceptual and detailed design and onto commissioning and qualification. It will also cover such associated project aspects as overall planning, budgeting and the organisational systems and structures required to successfully execute such major investments.

An overview of how biopharmaceutical manufacturing facilities operate will also be addressed so as the design of the facility from the material and personnel flows through to the process controls and automation, meet the needs of the operations personnel after the facility is brought into production.

1. Effectively plan the major elements of an investment in a biopharmaceutical manufacturing facility.
2. Evaluate and communicate the complex interconnecting elements of these major capital projects.
3. Identify and address the operational requirements for the manufacturing facility within the design.
4. Recognise and describethe main stages of facility design including cleanrooms and associated technology.

5. Critically evaluatethe principal steps involved in the overall commissioning and qualification of a new or modified biopharmaceutical facility.

6. Appraisethe typical organisational control systems and structures required for biopharmaceutical facility design and operation.

This module aims to provide students with an understanding of the main regulations and regulatory bodies associated with biopharmaceutical manufacturing, with a focus on Bio-Industry 4.0. It also provides students with the application of the validation concepts and how risk management is an integral part of this.

1. Demonstrate an understanding of the global regulatory framework for biotechnology derived products

2. Discuss how the nature and production of biotechnology products affects quality, safety and efficacy and Engage in and demonstrate independent learning as well as communicate effectively as an Individual and ora member of a team

3. Differentiate the applications of EU & US regulations for biopharmaceutical marketing authorisations

4. Categorise the principal risks associated with the manufacture of modern biopharmaceuticals and tools to evaluate them including the latest digital trends and technologies

5. Critically evaluate the main steps involved in the validation of upstream (cell culture processing) and downstream (protein purification) processes as well as cleaning, sterilisation, and viral control technologies in the manufacture of biopharmaceuticals including trends in digitalisation.

This module aims to provide students with the background of Industry 4.0 and how this conceptual framework can be applied in the biopharmaceutical sector. The course will provide students with the knowledge and understanding of the emerging needs of the biopharmaceutical sector as it progresses towards greater integration of technology and data, to become more agile, to increase productivity and competitiveness.

1. Demonstrate they have detailed knowledge and understanding of the background to Industry 4.0 and emerging needs in the biopharma sector, the source and quality of existing data and applicability of industry4.0

2. Demonstrate they have detailed knowledge and understanding of the application of predictive modelling, automation systems, PLCs, robotics, vision systems

3. Evaluate embedded systems, the internet of things (IoT) and the cyber-physical systems (sensors, control boards) necessary for data acquisition

4. Formulate judgements on the relevant value and application of existing data sources, design tools, digital twins, simulation models, and augmented reality/virtual reality.

5. Integrate knowledge and formulate judgements onthe application of robotics and industrial vision systems to biomanufacturing operations.

This module is designed to support students undertaking science-based study, through providing insights into effective directed learning, self-study, self-reflection, communication, and time-management. This will facilitate awareness and development of personal effectiveness and employability attributes and skills as engaged learners.

1. Critically evaluatediverse styles, skills, and tools for effective learning/communication, personal effectiveness, and employability in science.

2. Demonstrateability through the application of self-reflection/appraisal, critique, and writing/journaling skills applicable to life and work

3. Conceptualise, research and write reviews to illustrate learning from thought leaders in science, education, organization, and management.

4. Develop and apply effective time management/learning strategies and demonstrate personal engagement in relevant external reading and study.

This module is designed to provide an overview of the principles behind the commissioning and qualification of a biopharmaceutical production facility. The processes involved in the commissioning and qualification of the utilities and equipment used in a biopharmaceutical production plant will be covered throughout the module. A practical element is incorporated into the module, whereby students will gain an insight into the installation, commissioning and testing of the equipment and utilities used in biopharmaceutical manufacturing. It will equip students with the knowledge and skills required to perform commissioning of a bioprocessing plant, and the equipment related to the biotechnology industry.

1. Outline and evaluatethe stages involved in pre-commissioning, commissioning and start-up of facilities

2. Debatethe principles involved in commissioning planning.

3. Evaluatethe steps involved in testing of equipment

4. Outline and Evaluate the safety aspects of commissioning and installation of equipment

5. Critically evaluatethe key industry guidelines and regulations that are used for CQV and differentiate CQV activities

6. Actively Participate in the activities designed to start-up and check a system in a logical, organised, safe, and controlled manner in a simulated GMP environment.

This module will provide an overview of the regulatory, technical and management issues associated with the scale-up and technology transfer of industrial bioprocesses. The focus will be on giving a clear understanding of the technical and regulatory requirements and approaches necessary to obtain regulatory approval for product scale-up and transfer. It will provide guidance on how to implement efficient and effective projects and will also address such areas as process validation and the typical costs associated with these projects.

1. Discuss and evaluate the important process, engineering and regulatory aspects of technology transfer.
2. Formulate and communicate effective planning of a technology transfer process.

3. Provide some practical examples of technology transfer aspects and features.

This module aims to provide students with an understanding of the key concepts of Industry 4.0 and outlines the application of the latest digital trends and technologies in the Bio-Industry 4.0 field, and how they can be practically applied.

1. Critically assess the smart factory concept in the biopharma industry, considering digital supply network, real-time data, optimised and predictive production.

2. Evaluate the role of PAT in the implementation of the smart factory concept, focusing on efficient use of data from different sources old and new, to bring about measured efficiencies and controls.

3. Evaluate the current applications of automation and the future potential applications and benefits of automation and data integration in the implementation of the smart factory including theidentification of challenges.

4. Demonstrate an understanding of the ISA-95 model, the international standard for the integration of enterprise and control systems, along with other automation standards such as NAMUR and Profinet.

5. Covering the entire bioproduction supply-chain from design to delivery of the product to the patient, learn to evaluate various digital tools reproducing essential production elements (digital twins, serious games, immersive reality, virtual reality, and augmented reality) and cognitive approaches supported by artificial intelligence to promote understanding of processes and the appropriation of professional practices, using case studies where appropriate.

6. Engage in and demonstrate independent learning as well as communicate effectively as an Individual and ora member of a team

This module is designed to support students in the personal development of professional skills focussed on the workplace including engagement in enriching workplace-based learning activities and placement. Students will gain experience of a variety of activities relevant to the programme and reflect on their role and evolving skill base in the context of the workplace. Throughout the module, students will maintain a structured reflective journal/portfolio, logging activities and demonstrating personal reflection and development, and at the end of the module provide a concise report and presentation summarizing aspects of their reflective experiences and key learnings.

1. Develop professional skills including written communication skills, presentation, interview, time management, project management, and conflict resolution skills.

2. Reflect on the mission/vision, aims/objectives, and structure of relevant organization and conduct SWOT analysis of a defined workplace function/structure, methodology, practice, or policy, and also a personal SWOT analysis.

3. Detail how a clearly defined workplace methodology, practice, or policy they have personally used could be applied in another context with the industry sector.

4. Demonstrate advancement in personal effectiveness and reflective learning approaches relevant to the workplace.

5. Articulate how module learning and experiences have contributed to personal and professional development and skills enhancement.

6. Independently plan and manage personal learning to deliver quality outputs/outcomes according to agreed deadlines.

7. Reflect on performance enhancement and demonstrate ability to undertake self-appraisal.

8. Evidence indicators of having undertaken appropriate continuing professional development (CPD) and ability to identify and partake in professional/career development activities.