The learners engage in an independent research project where they use the skills & competencies acquired in the program of study to research an area of relevance to Good Manufacturing Practice (GMP).

1. Work independently on a GMP project.
2. Source literature relevant to the project.
3. Plan & organise activities within a specified timeframe.

4. Interpret & evaluate research findings.
5. Present a report (written and oral) on the research findings.

This module aims to provide the student with a fundamental understanding of both the theory and practical aspects of cell culture processing as it pertains to the manufacture of modern biopharmaceutical products.

1. Describe cell biology

2. List the different types of cells that can be used in biopharmaceutical manufacturing and their advantages and disadvantages.

3. Describe how cells produce protein.

4. Explain cell growth kinetics and scale up.

5. Describe and perform cell counting.

6. List and discuss the equipment used in a cell culture facility

7. Discuss and identify bioreactor features.

8. Explain bioreactor control.

This module aims to provide students with a general knowledge and understanding of a number of analytical test methods employed in the Quality Control analysis of Biopharmaceutical products.

1. Describe the main stages involved in the production of a biopharmaceutical product

2. Outline the structure of a protein

3. Outline the importance of protein stability for biopharmaceuticals

4. Outline the principal test methods employed in the analysis of a biopharmaceutical product.

5. Outline the main aspects of biopharmaceuticals that require characterisation.

This module aims to provide students with a general knowledge and understanding of the key principles and methods of biocontamination control as it relates to aseptic processing operations in the biopharmaceutical industry.

1. Describe the main stages involved in the production of a biopharmaceutical production process

2. Identify the main sources of contamination and their entry routes into a biopharmaceutical production facility

3. Describe the principles of environmental montoring in a biopharmaceutical production facility.

4. Outline the key differences between cleaning, sanitisation and sterilisation

5. Describe the different types of micro-organisms that may lead to contamination

This module aims to provide students with a general knowledge and understanding of the main principles and methods of operation for cleaning systems, sanitisation of systems and the principal utilities involved for Biopharmaceutical processing. Students will develop an understanding of the common residues or soiling that occur in a biomanufacturing environment and the selection of appropriate cleaning agents for each situation. Discussion of critical utilities for water and steam will also be provided.

1. Identify and describe the types of residue that commonly occur in Biopharmaceutical Processing environments and the appropriate cleaning systems to cope with each, including COP and CIP

2. Describe the key principles involved in the sanitisation of systems for Biopharmaceutical Processing including detergents, disinfectants etc

3. Explain the key elements of a purified water treatment system including the generation of PW and WFI.

4. List and describe other important utility systems for Biopharmaceutical Processing including Clean Steam, Process Air/Gases etc.

5. Outline the main analytical technologies and techniques that apply to cleaning, sanitisation and utilities.

This module aims to provide students with a general knowledge and understanding of the key aspects of cleanroom design, control and operations as they relate to the biopharmaceutical industry.

1. Describe the maindesign features of a typical cleanroom.

2. Explain the different cleanroom classifications and their typical applications.
3. Describethe principal gowning practices forcleanroom operations

4. Describe how environmental monitoring is used to assess cleanroom cleanliness.

5. Define the principal cleaning requirements for a cleanroom.

6. Describe the benefits and applications of various pressure differentials and airflow patterns within cleanrooms.

This module aims to provide the student with a fundamental understanding of both the theory and practical aspects of protein purification processing as it pertains to the manufacture of modern biopharmaceutical products.

1. Describe the principal stages of downstream processing for protein products.

2. Outline the structure and function of protein biopharmaceutical products.

3. Outline the main harvesting techniques used for purification of a protein product.

4. Describe the basic theory and practice of column chromatography for purification applications.

5. Describe the basic theory and practice of ultrafiltration and diafiltration operations for protein purification.

6. Outline the main unit operations required for viral clearance.

7. Perform a range of practical laboratory experiments relating to downstream bioprocessing operations.

This module provides students with a general knowledge and understanding of the critical aspects of aseptic/sterile technique as it relates to filling operations for the biologics Industry.

1. Describe the fundamental aspects of sterile filling operations for biopharmaceutical drug products.

2. Outline the main equipment involved in sterile fill finish operations and their modes of operation.

3. Describe proper gowning principles and procedures for aseptic processing.

4. Explain the use of media fill protocols for determining the sterility of a typical filling process.

5. Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing.

This module aims to provide students with practical skills and an overall understanding of the key technologies used in sterile filling operations in the biopharmaceutical industry.

1. Demonstrate an increased proficiency in the techniques and skills associated with aseptic processing.
2. Outline the main steps involved in setting up a sterile fill system.

3. Outline the gowning and environmental monitoring techniques required for aseptic processing.

4. Demonstrate the concept of a media-fill for a typical filling operation.

5. Perform practical laboratory experiments for clean out of place and steam out of place operations.

6. Perform practical laboratory experiments for sterilisation and autoclaving.

This module aims to provide students with a general knowledge and understanding of the principles and methods of sterilisation used in bio/pharmaceutical and healthcare industries. While the primary focus will be on steam sterilisation, consideration will also be given to other forms of sterilisation including filtration, dry heat sterilisation, chemical sterilisation, and the use of ionizing and non-ionizing radiation. A discussion of sterilisation validation will also be provided.

1. Describe the main forms and types of sterilisation technologies available to the Biopharmaceutical Industry.
2. Explain the sterilisation concepts of D-value, Z-value, Fo and SAL and their overall importance in the design and operation of sterilisation applications.
3. Describe the operation of a typical steam sterilisation application such as an autoclave or an SIP system.
4. Compare other forms of sterilisation such as dry heat depyrogenation, ethylene-oxide, vaporised hydrogen peroxide, gamma irradiation and e-beam technology.

5. Outline the main steps involved in the overall validation of a typical sterilisation cycle.