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 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.