This module aims to provide students with a detailed knowledge and understanding of the various analytical test methods used in a biopharmaceutical Quality Control laboratory. The module will focus on the scientific principles behind each method, analytical platforms used and their application in biopharmaceutical analysis.

1. LO1) Describe test specifications, CQAs and the routine testing strategies typically employed for analysis of biologics.

2. LO2) 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 from a wide range of information sources to demonstrate an in-depth knowledge of the subject matter.

3. LO3 Formulate and communicate judgements with regard to current and emerging biopharmaceutical analytical techniques and instrument platforms.

4. LO4) Develop professional practice skills including time-management, scientific writing and oral communication skills.

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 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.

1. Discuss and critically evaluate the most relevant microbes for the biopharmaceutical industry and identify and discuss appropriate prevention techniques for each contaminant.

2. Source and interpret the theory behind the detection test methods available, including traditional and rapid identification testing.

3. Develop and justify an appropriate monitoring regime for a pharmaceutical/biopharmaceutical facility.

4. Describe the relevant regulatory expectations for Biocontamination Control including ICH Q8, Q9 and Q10.

5. Perform research on a relevant topic and analyse, evaluate, communicate and explain scientific data relating to biocontamination control.

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 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.

This module examines all aspects of the application of Lean Processing and Six Sigma principles to Biopharmaceutical Processing.

1. Evaluate and discuss the key principles of Lean Manufacturing and their typical applications for bioprocess industries.
2. Evaluate and discuss the key principles of Six Sigma programmes and their typical applications for bioprocess industries.
3. Appraise the application of Lean tools such as Value Stream Mapping, SMED, 5S, Visual Management, TPM, Kaizen Events, Creating Continuous Flow.

4. Appraise 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 biopharmaceutical process demonstrate the application of a combination of Lean-Sigma tools for both a core manufacturing process sequence as well for a support function or administrative sequence.

This module aims to provide the student with a fundamental understanding of the key elements, phases and tools of Project Management from concept to project completion in order to enable the student to more effectively manage future projects in this industry.

1. Identify and discuss the main elements and phases of Project Management from concept to final completion, evaluate the role of the project manager and critique leadership styles.

2. Demonstrate expertise in the preliminary phase of project management including project initiation, risk management, stakeholder identification and communication planning.

3. Critically evaluate the main tools available for successful project progress planning, monitoring and tracking including Gantt charts, work breakdown structures, network diagrams and other resource allocation techniques, cost tracking to budget etc. Apply MS Project or other relevant software.

4. Explain the close-out phase of project management including final commissioning, takeover of facility / process, final contract settlement, formal post-project review and construct lessons learnt.

5. Evaluate project feasibility and synthesise conflict resolution approaches.

This module examines the emerging new technologies in the biopharmaceutical industry. It evaluates the current trends towards improved productivity, and also evaluates the increasing diversification in the product pipeline. The practical component of the module covers many of the skills associated with the use of single-use technologies in biopharmaceutical processing.

1. Outline and evaluate the key trends towards improved productivity in the biopharmaceutical industry.

2. Describe the challenges of creating a modular, fully single-use facility.

3. Describe the theory and challenges associated with continuous bioprocessing for both upstream and downstream bioprocessing operations.

4. Describe the increasing diversification in the product pipeline, outlining advances in cell therapies, gene therapies, combination products and precision medicines.

5. Demonstrate a range of practical skills associated with single-use technologies used for both upstream and downstream processing operations.

The purpose of this module is to complete a research proposal which may subsequently form part of the MSc thesis. Students will have the opportunity to formulate a research topic, develop a research schedule and select appropriate methodologies for a research project. The learner will study different research methods, ethical considerations, learn how to critically analyse scientific documents, disseminate research in terms of reports, and communicate effectively.

1. Produce a research proposal document.

2. Undertake a focused literature search and generate a literature review on a research topic.

3. Select and apply an appropriate research methodology while adhering to ethical considerations.

4. Communicate effectively their research outcomes.