Please write an individual report entitled: “What steps, component parts and enabling tools would you use to develop a therapy that would be classified as an Advanced Therapy Medicinal Product / Regenerative Medicine Therapy” The report should be 2,500 words long, and where possible use examples of where techniques, tools/enabling tools and technologies of the Chemical Engineer are used to create, develop and improve Advanced Medicinal Products and Regenerative Medicines.

To do this, consider the problem genes, cells, disease, tissue or organ that you want to select and then consider the various steps in the development of an Advanced Therapy Medicinal Product. Please follow the usual format for writing a report. Please use the usual full format for a scientific report which should include a Title Page with your name, student number, date etc., Table of Contents, Table of Figures etc., and then it should follow a format along the following structure: Brief Abstract Given the word count, limit this to around 150-200 words maximum to summarise the report background and findings.

Introduction: Provide a very brief description of the ATMP area generally, then specifically focusing on the cell or gene approach for the tissue/organ/disease that you are developing a therapy for. This part should also provide a brief overview of the history as well as its current regulatory/business/market analysis both nationally (UK) and internationally. Process Overview Briefly provide an overall description of the processing steps required in the production relating to your ATMP .

Provide a process flow sheet (i.e. from component parts required through development to final product) and use this as the basis for your discussion in this section. Main processing step Overview Select a single step, from the full processing line you previously outlined, that in your opinion is the most significant one and describe this further. Make sure that you provide some justification for your selection.

Conclusions & Future perspective Your discussion here should address, but not necessarily be limited to, the following areas/questions:

• How do you think the overall processing line, and the specific process you have chosen as your focus, have changed over the years?
• What are the benefits that these changes have offered to the patient/clinician or ATMP industry Where does current research in this area focuses on?
• Where do you think there are still improvements to be made for advancing therapies beyond their current capabilities?

Figures / Images Please make good use of your own diagrams, flowcharts or appropriately referenced images within the document to help illustrate the narrative of the report.

References The discussion throughout your report should be based on available scientific sources/evidence (i.e. your references) related to the area of your topic. In this section, please provide a list of these key references and make sure that these have been appropriately cited in the main body of your report.