This module addresses the theory and practical aspects of cell culture processing as it pertains to the manufacture of modern biologic products. The relevant learning is acquired through a series of lectures and the completion of a sequence of laboratory-based and pilot-plant based practical classes, with experiments designed to impart the required knowledge, know-how and skills relevant to this area.

1. Identify and evaluate key factors involved in the design of an upstream bioprocess.

2. Evaluate and discuss the various designs of bioreactors and the key parameters involved in bioreactor operation.

3. Demonstrate a range of practical knowledge and skills associated with both lab and pilot plant-based upstream bioprocessing techniques and equipment relevant for the biopharmaceutical industry.

4. Interpret, critically evaluate and effectively communicate results obtained from the various bioprocessing practicals.

This module addresses the theory and practical aspects of downstream processing as it pertains to the manufacture of modern biologic products. The relevant learning is acquired through a series of lectures and the completion of a sequence of laboratory-based and pilot-plant based practical classes, with experiments designed to impart the required knowledge, know-how and skills relevant to this area.

1. Identify and evaluate key factors involved in the design of a typical downstream process for biopharmaceuticals.

2. Analyse the theory and evaluate key factors involved in chromatography selection for downstream processing applications.

3. Explain and evaluate filtration systems for recovery, concentration and viral clearance.

4. Demonstrate a range of knowledge and skill in standard and specialised techniques used in downstream protein capture and purification at both lab and pilot-plant scale of operation.

5. Interpret, critically evaluate and effectively communicate results obtained from the various bioprocessing practicals.

This course is designed to provide specialised knowledge in the theory, practice and interpretation of the various assays and instrumentation routinely employed in a biologics quality control (QC) testing laboratory. Biologic therapeutics have numerous critical quality attributes (CQA's) that can potentially impact drug safety and efficacy. Consequently, many orthogonal techniques are required for the analysis of biological drugs. This course guides students through the CQAs of biologics (ICH Q6B) as well as core analytical methods and platforms routinely employed in a QC testing laboratory to measure them. 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. Describe test specifications, CQA’s and the routine testing strategies typically employed for the routine analysis of biologics.

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

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

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. Discuss and apply the fundamentals of pre-formulation and formulation for a biologic drug.

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

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

5. Discuss and evaluate the concept of drug targeting and controlled release systems.

This module is taken by Masters students in Bioprocessing. It aims to provide students with an understanding of the risks associated with biopharmaceutical processing and how regulations translate into the manufacturing environment. It also provides students with an understanding of the main validation concepts as well as the application of continuous improvement initiatives in bioprocessing.

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

2. Understand how the nature and production of biotechnology products affects quality, safety and efficacy

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

4. Evaluate the regulatory requirements of equipment qualification, process validation, and life cycle management

5. Appraise the principles of lean-six sigma, statistical process control and other current quality improvement initiatives.

6. Engage in and demonstrate independent learning as well as communicate effectively as an

Individual and as a member of a team

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.

The research project will allow the learner to investigate an area of interest relevant to their professional field, using knowledge skills and competencies acquired at earlier stages of the Master's Programme, to research an area deemed appropriate by an academic Supervisor. The research project begins with choosing an appropriate topic to research and an initial detailed literature search to establish existing state-of-the-art studies in the chosen area. Learners will examine and define the issues/research question, develop a research proposal, select and execute appropriate methodologies, analyse data, evaluate findings critically and draw justifiable conclusions, demonstrating self-direction and originality of thought. The learner will be allocated a supervisor who will advise on the direction of the work. Throughout the period of research, the learner is encouraged to network with other researchers in academia and industry (where an Industry link/project occurs) and to disseminate their research findings in oral and written format to both academic and professional audiences. The work will culminate with the submission of a research thesis and a viva voce.

1. Manage an independent research project with a support structure in place for supervision.

2. Source and critically evaluate academic literature (and literature from a wide variety of other sources), to draw inferences from this body of knowledge to conduct an extensively focused literature review.

3. Develop and justify a coherent research proposal with an acceptable research question or hypothesis.

4. Conduct the project by selecting and applying appropriate research methodology and analysing the data according to accepted models of analysis. Sustain from the evidence obtained, a reasoned argument and draw consistent and coherent conclusions from the research evidence.

5. Reflect selfcritically and express the relevance and significance of the outcomes/conclusions of the enquiry and on the research process itself.

6. Write a thesis which meets postgraduate standards of technical expertise investigating the subject area or testing the hypothesis outlined in the research proposal.

7. Develop professional practice skills including goal setting, time-management and scientific writing skills.

8. Develop the skills to present and defend aspects of their research at seminars, conferences and vivas.