This module examines all Bioprocessing aspects, both upstream and downstream, of a typical biopharmaceutical production process. It includes the various design factors that need to be considered for bioprocess design. In line real time monitoring tools including Process Analytical technology (PAT) will be addressed. The primary focus will be on recombinant mammalian cell culture lines with some aspects of microbial cell lines also included.

1. Recognise and analyse the main steps involved in the development of a genetically-modified cell-line designed to express a modern biologic drug product.
2. Identify and evaluate key factors involved in the design of an upstream bioprocess system including which cell line to choose for a particular processing application.
3. Evaluate and discuss the various designs of bioreactors available and their key features including relative advantages and disadvantages. Also describe the different modes of bioreactor operation.
4. Describe the main aspects of bioreactor control and operation including the various instrumentation types involved.
5. Design an effective and efficient downstream process for a protein capture and purification application.
6. Anlayse the theory and practice of chromatography for purification applications including the various types available.
7. Interpret and explain other potential downstream processing technologies such as microfiltration, ultrafiltration, diafiltration, centrifugation, electrophoresis and viral exclusion techniques.
8. Outline and evaluate the main quality control and analytical techniques required for downstream processing.

This module is taken by Masters students in Biopharmaceutical Science. It aims to provide students with a detailed knowledge and understanding of legislation and Regulatory affairs in EU and US with a particular focus on Biopharmaceuticals and Biologics.

1. Demonstrate they have detailed knowledge and understanding of the main regulatory institutions in the EU, USA, and Rest of World and their workings.
2. Demonstrate they have a detailed knowledge and understanding of the ICH and regulatory harmonisations.
3. Integrate knowledge and understanding of the Drug development/Clinical Trial Process with the Drug approval process for both Europe and USA and evaluate relevant case studies.
4. Understand the Drug approval process for both Europe (centralised procedure) and USA (NDA) and the different routes (decentralised Procedure, MRP) that can be taken based on the type of drug being approved (API, Generic, New Drug)
5. Source and evaluate the directives and annexes currently regulating pharma/biopharma production, placing on the market,pharmaco-vigilance, PQRs, and product falsification within the EU.
6. Demonstrate a detailed knowledge of the different roles and responsibilities to ensure legal marketing, manufacture, distribution and sale of drugs.
7. Understand the challenges associated with manufacture of biopharmaceutical products and source and interpret current legislation relating to them.
8. Demonstrate a knowlege of biosimilar drugs and source and interpret the legislation associated with getting approval in the EU and USA.
9. Engage in and demonstrate independent learning as well as communicateeffectively as an individual and as a member of a team.

This module is taken by Masters students in Pharmaceutical or Biopharmaceutical Science or Engineering. It aims to provide students with a detailed 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. It does this through consideration of facility design, basic microbiology, evaluation of relevant microbes, potential sources of microbial contamination, correction/prevention tools, monitoring and detection methods, consideration of all relevant regulations and case study evaluation. Documentation (including ISO and USP) relevant to biocontamination Control will be addressed. Quality assurance and Quality systems will be addressed in the context of Biocontamination control.

1. Discuss and critically evaluate the most relevant microbes for the biopharmaceutical industry and the typical sources of each.
2. Identify and discuss appropriate prevention techniques for each contaminant.
3. Source and interpret the theory behind the detection test methods available, including traditional and rapid identification testing.
4. Describe and apply the concept of Biocontamination Control by Design.
5. Develop and justify an appropriate monitoring regime for a pharmaceutical/biopharmaceutical facility.
6. Outline and justify an appropriate system/process for Biocontamination control and incorporate all elements of a GMP quality system referencing the relevant standards and regulations associated with biocontamination control.
7. Describe the relevant regulatory expectations for Biocontamination Control including ICH Q8, Q9 and Q10 and how CAPA can be used in response to a regulatory audit.
8. Formulate and communicate judgements with regard to Biopharmaceutical contamination case scenarios.

This module is taken by Masters students in Bioprocessing. It aims to provide students with a detailed knowledge and understanding of the various analytical test methods used in a biopharmaceutical Quality Control laboratory to assess the raw material, in-process, bulk drug substance and finished product quality attributes.

1. Discuss and critically evaluate the applications of the test methods listed in a biopharmaceutical product analysis.
2. Source and interpret the theory behind the test methods listed.
3. Identify and interpret equipment requirements for performance of the test methods listed.
4. Formulate and communicate judgements with regard to biopharmaceutical analytical techniques.
5. Source relevant information, critically interpret and apply appropriate referenced literature from a wide range of information sources
6. Demonstrate effective communication skills in an appropriate format.

The purpose of this module is to provide students with a range of skills necessary for good research practice in academic and biopharma environments. Students will be introduced to the appropriate theoretical perspectives involved and are provided with training in various research methodologies and techniques. Skills in scientific communication skills will also be addressed. The formal requirements of a dissertation will be outlined in order to prepare the student for the process of writing a masters' thesis.

1. Demonstate an understanding of scientific research,the steps involved in aresearch process and the various research methodologies.

2. Apprecaite the needfor research integrity and apply these values in written and oral communications.

3. Develop and apply critical evaluation, reflection and interpretation skills.

4. Develop and communicatethe skills required for presenting and publishing research.

This module addresses the practical knowledge, know-how and skills associated with the bioprocessing, both upstream and downstream, of modern biologic drug products. The relevant learning is acquired through the completion of a sequence of laboratory-based and pilot-plant based practical's and experiments that are designed to impart the required knowledge, know-how and skills.

1. Demonstrate a range of practical know-how and skills associated with relevant, lab-based and pilot plant-based upstream bioprocessing equipment for the Biopharmaceutical Processing industry.
2. Demonstrate a range of knowledge and skill in standard and specialised techniques in downstream protein capture and purification at both lab. and pilot plant scale of operation.
3. Interpret and critically evaluate the data and results obtained from the various bioprocessing practicals.
4. Take responsibility for and direct the work of other individuals in a quasi-GMP environment.
5. Demonstrate research skill and capabilities in the overall bioprocessing area.
6. Evaluate ongoing education and training needs in a continuous professional development environment.
7. Demonstrate effective communication skills both orally and in writing.

This module deals with advanced methods of biopharmaceutical formulation and finish for stable drug delivery. It aims to provide students with a critical overview of the challenges faced in the formulation and administration of biopharmaceuticals and the strategies being adopted to overcome these barriers. The latest advances for successful formulation and delivery of biologic drugs will be described.

1. Assess the various challenges faced in the design and formulation of a biopharmaceutical drug.

2. Discussandapply the fundamentalsof pre-formulationand formulation fora biologic drug.

3. Describe and evaluate modern formulation technologies for use with biologic drugs.

4. Appraise and investigate the various delivery routesfor a modern therapeutic protein.

5. Discuss and evaluatethe concept of drug targetingand controlled release systems.

Operations Management in the Biopharma/Pharma industries details the methods, systems and tools used in management of products, processes, services and supply chains. Implementation of Lean and Six Sigma methodologies into manufacturing operations for the Biopharma and Pharma industries is now a common practice to ensure success and an effective continuous improvement environment.

This module provides an overiew of operations management incorporating the acquisition, development, and utilisation of resources needed to deliver supply on demand. As part of this it will demonstrate a number of lean six sigma tools which can be used to achieve this.

1. Describe the strategic importance of operations, the capabilities and limitations of the operations function
2. Demonstrate an understanding of the concepts and methods related to designing and managing a Biopharma/Pharmaceutical operations facility including: a. The sequence of steps involved in bringing a product to market, from order confirmation, receipt of material through production to delivery shipment. b. Demand forecasting & planning, production scheduling & control methods c. Modern facility layout and process flow d. Technology transfer and project management
3. Develop a skillset for organizing activities as part of a project / process – from conception of system interrelation, to organize activities effectively, to analysing processes KPIs, continual process improvement.
4. Analyse the operations/system output and/or data using appropriate lean six sigma tools such as SPC, value stream mapping, visual management, experimental techniques and models and examine improvement methodologies; JIT
5. Evaluate and discuss the key principles of Lean Six Sigma Manufacturing and their typical applications for bioprocess industries.
6. Demonstrate the application of Lean Six Sigma tools such as Value Stream Metrics, SMED, 5S,Visual Management, TPM, Kaizen Events, Risk Management, Creating Continuous Flow, Process Capability, FMEA and Error Proofing.
7. For a typical biopharmaceutical process demonstrate the application of a combination ofLean-Sigma tools for manufacturing operations.
8. Engage in and demonstrate independent learning as well as communicateeffectively as an individual and as a member of a team.

This practical module aims to provide specialised knowledge in the theory, practice and interpretation of the various assays and instrumentation routinely employed in a Biopharmaceutical Quality Control laboratory. The necessary skills and competencies will be acquired through a combination of self-study and the completion of a sequence of laboratory-based practicals and demonstrations.

1. Outline and evaluate the main quality control and the various assays/tests methods routinely employed in the analysis of biopharmaceuticals.
2. Perform a range of analysis and outline and evaluate the equipment requirements for performance of the various test methods.
3. Interpret and critically evaluate the data and results obtained from the various practicals and demonstrations.
4. Take responsibility for and direct the work of other individuals in a GMP- like environment.
5. Evaluate and apply scientific and technical information to solve/troubleshoot analytical problems and demonstrate research capabilities.
6. Demonstrate effective communication skills both orally and in writing.

The objective of this module is to give students a thorough appreciation of process validation considerations associated with the manufacture of biopharmaceuticals. The approach characterises the process development of a biopharmaceutical from when it progresses from the research entity off the laboratory bench, and forward to the initial clinical trials phase right up through to full scale manufacturing.

The focus is on the rational and science based decisions in determining the critical process parameters and quality attributes, and the subsequent setting of the manufacturing operational limits, with the ultimate goal of validating the full scale manufacturing process.

1. Describe and critically evaluate process validation considerations for biopharmaceuticals.
2. Outline the standard industry validation definitions, terms and methodologies.
3. Analyse and identify the process validation prerequisites in terms of validation planning and validation work flow.
4. Evaluate the various process development considerations for the full scale manufacture of biopharmaceuticals, such as analytical methods, manufacturing equipment, facilities and process technology.
5. Develop suitable validation approaches to achieve process validation over the product lifecycle.
6. Explain the necessity for post validation activities such as change control, ongoing process monitoring and process revalidation have in maintaining the validated state.
7. Develop a system of documentation necessary to support process validation activities such as protocols, operation and maintenance.
8. Contribute to the execution of process validation methodology, and develop the overall report to the process validation study.