This module 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.

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 aims to provide students with an understanding of the main considerations in the formulation and fill finish of a biopharmaceutical.

1. Describe protein structure and what contributes to protein destabilisation.

2. Describe what excipients are added to a protein formulation and why they are added.

3. Explain the principles and applications of typical fill-finish and freeze-drying technologies.

4. Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.

The subject aim is to introduce the students to the drug discovery and development process. The subject will compare traditional pharmaceutical drug development to biopharmaceutical drug development. The module will include an in depth study of the different modes and methods of recombinant protein expression in different cellular hosts. The module will introduce the analysis and manipulation of recombinant protein expression in the biopharmaceutical sector.

1. Differentiate between irrational and rational drug design. Describe the methods of drug target identification and validation.
2. Outline the molecular methods and components required to characterize, clone and express a gene of interest.

3. Categorize the essential steps in the design and regulation of a recombinant expression system.
4. Examine methods of verifying the functional and molecular characteristics of the recombinant protein.
5. Perform research on a relevant topic and analyse, evaluate and communicate and explain scientific data relating to Recombinant Drug development.

This Biopharma laboratory practical module will provide students with practical knowledge, know-how and practical skills associated with biopharmaceutical operations. The relevant learning is achieved through the completion of a sequence of laboratory-based and pilot-plant based practicals and experiments that are designed to impart the required expertise. There will also be some research project work associated with the laboratory practicals.

1. Demonstrate a range of practical knowledge and skills associated with upstream bioprocessing operations

2. Demonstrate a range of practical knowledge and skills associated downstream bioprocessing operations.

3. Demonstrate a range of practical knowledge and skills associated with aseptic processing and filling operations

4. Perform project work related to the practical sessions

5. Evaluate the data and results obtained from the practical sessions

6. Demonstrate effective communication skills in a written format.

The project aims to provide students with the opportunity to apply and integrate the skills and knowledge they have gained on the programme of study to date. The student should bring the learning from the modules covered in the course to conceive, define and agree a project which is relevant to the subject matter they are studying. A supervisor will be assigned to each project. The supervisor will act as a guide in agreeing the relevance and scope of the project and monitor the progress on a regular basis. Updates will be sent to the supervisor on an agreed basis.

1. Identify a problem which needs to be addressed of importance to the organisation.
2. Complete and present a comprehensive literature survey report on the results of their preliminary study.
3. Utilise an appropriate structured approach to manage the project with realistic, interim and overall project objectives.
4. Enhance research skills and abilities and analytical techniques as well as problem-solving capabilities.
5. Present project results with Executive Summary, Conclusions and Recommendations and discuss the approach taken and results achieved.
6. Enhance communication skills through presentations, report writing and defense of their research findings.

This module aims to provide the student with a good understanding of the main support service areas involving both facilities and utilities that underpin the modern biopharmaceutical manufacturing industry.

1. Outline the main elements and features of facilities and utilities relating to the modern biopharmaceutical industry.
2. List and describe the main facility design concepts including cleanroom technology for Biopharmaceutical Processing.
3. Describe the key elements of a water treatment system for Biopharmaceutical Processing.
4. Describe the key principles involved in cleaning and sterilisation systems for Biopharmaceutical Processing.
5. Understand the application of minor equipment and design and testing principle of piping systems within a Bioprocessing Facility.

6. Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.Communicate and explain scientific data relating to facilities and utilities for biopharmaceutical processing.