This module is taken by Level 9 students enrolled in either the Postgraduate Certificate in ATMP Cell Manufacturing or the MSc in ATMP technology and Manufacturing / MSc in ATMP Cell Manufacturing Development. It aims to provide students with a background to the concept of ATMPs, including a definition as to what they are from a regulatory standpoint, and a description of the current therapeutic modalities. Furthermore, this module will include an overview of current manufacturing practices for these therapies as well as a brief description of some aspects of quality control.

1. Demonstrate detailed knowledge and understanding of the background to ATMPs including current and emerging product types.

2. Describe the manufacturing process required for allogeneic and autologous cell therapies (incl. ex vivo gene therapies)

3. Evaluate current / emerging cell-based therapies for the treatment of inflammation, tissue repair, and cancer and examine associated ethical and societal issues

4. Evaluate current / emerging gene therapy / editing for the treatment of both genetic disorders and other disorders of non-genetic originand examine associated ethical and societal issues

5. Examine the concept of a viral vector for gene therapy delivery and design the associated manufacturing flow

This module is taken by Level 9 students enrolled in the Advanced Therapy Medicinal Products (ATMPs) course. It aims to provide student with an understanding of how molecular engineering has framed the biopharmaceutical industry's approach to the design of ATMP's both currently on the market and in the clinical trial pipeline. This module will provide students with the necessary skills and tools to understating how ATMP's are engineered to be an effective therapeutic on a molecular and protein level, and the potential of emerging innovations in this field.

1. Detail thedesired molecular characteristics of ATMPs and how this impacts the therapeutic potential of the product and how these characteristics are engineered into the process.

2. Evaluate the technology used in the development and manufacture of ATMPs that have achieved regulatory approval and are currently on the market.

3. Review emerging molecular engineering technologies that are currently undergoing research and development in the design of novel ATMPs.

4. Critique the role molecular engineering and design have in the ATMPs currently undergoing clinical trials and discuss the challenges they possess in gaining regulatory approval.

5. Construct molecular engineering approaches that may be utilized in the future generation of ATMPs.

The Cell Processing 1 module introduces the basic concepts and issues pertaining to the culture of mammalian cells. The module outlines the growth requirements of cells in culture including the various media which may be used and how cells are grown and stored by cryopreservation. Issues relating to chemical and biological contaminations which may impact on cell culture are described. Identification of cell viability using visual techniques and assays are discussed. Regulatory requirements for starting materials in cell culture, cell identification and cell purity are also discussed.

1. Describe the basics of mammalian cell culture, cell growth and cryopreservation, as it applies to producer cell lines and packaging cell lines

2. Explain the different types and formulations of media / starting materials available and examine their overall importance in optimising the cell culture process and ensuring integrity of the culture

3. Evaluate contamination and biosafety issues and propose in process QC analytical test methods

4. Appraise different cell identification markers for their role in QC analytics

5. Problem solve simulated cell processing quality issues through case studies

The Biocontamination Monitoring and Control module introduces the concepts and issues pertaining to biocontamination control with respect to the culturing of mammalian cells and preparation of viral stocks for ATMP manufacture. The module outlines the unique challenges presented when developing ATMPs which due to their short shelf life require the use of rapid methods of detection when screening for contaminants.

1. Describe the basics of biocontamination control and best practice

2. Explain the different types of rapid methods available for screening for the presence of bio contaminants including endotoxins viruses and mycoplasma in raw materials, cell and viral stocks.

3. Develop a biocontamination control strategy with respect to raw material release and allogeneic donor recruitment.

4. Problem-solve simulated quality issues through case studies of biocontamination incidents.

5. Understand the regulatory expectations with respect to biocontamination control when manufacturing ATMPs.

The Cell Processing 2 module aims to provide students with the essential knowledge regarding cell processing and cell alteration within the ATMP space. It introduces cell based therapies, such as mesenchymal or stromal stem cells, CAR-T cells, CAR-NK cells etc. The module will cover the life cycle of the cell from donor recruitment, cell selection, segregation, manipulation, formulation, QC release and delivery, introducing and current and future technologies and techniques. The module will also examine regulatory requirements and evaluate ethical and societal impact of these technologies.

1. Describe the production cycle of a therapeutic cell product from donor to patient, being cognisant of the phenotypic and functional characteristics of cell therapies, patient safety,GMP and other regulatory conditions.

2. Describe and evaluate different transfection techniques for cell modification

3. Appraise new technologies for cell sorting, formulation etc and compare different methodologies for different cell products

4. Formulate judgement on appropriate QC tests and analyse simulated QC data

5. Construct proposals for an application of cell therapies to meet an unmet clinical need and defend safety, societal and ethical impacts of these technologies.

This module aims to provide students with an understanding of Qualified Person (QP) certification responsibilities and considerations for Advanced Therapy Medicinal Products (ATMP) and how they differ to traditional pharmaceuticals. In addition, the students will get an overview of the EU and US regulations that apply to ATMPs with a focus on QP aspects.

1. Describe the responsibilities of the QP when certifying ATMPs

2. Differentiate between EU and US regulations and guidances in relation to manufacturing and testing of ATMPs

3. Evaluate and describe vendor qualification requirements for ATMPs

4. For a given ATMP, determine the importation, distribution and transportation requirements for ATMPs

5. Assess ATMP manufacturing and testing challenges and construct solutions