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 describe the main stages of facility design including cleanrooms and associated technology.

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

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

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. Appraise the 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 describe the 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 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 or a 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 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 evaluate the stages involved in pre-commissioning, commissioning and start-up of facilities

2. Debate the principles involved in commissioning planning.

3. Evaluate the steps involved in testing of equipment

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

5. Critically evaluate the 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.