This module aims to provide students with the background in nucleic acid biology, current implementation and the future of their role in healthcare. The course will provide students with the knowledge and understanding of the emerging role Nucleic Acid Therapies (NATs) in both current and future therapies.

1. Describe nucleic acid biology in detail

2. Discuss and evaluate the potential clinical significance of nucleic acid therapies (NATs), critiquing current research.

3. Differentiate between different NATs for different applications and describe / predict their modes of action in vivo .

4. Evaluate current mRNA vaccine technology and appraise advances in this technology.

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

Operations Excellence and Risk Management details the philosophy, continuous improvement methods, systems and tools used in management of products, processes, services and supply chains to achieve excellence. This module aims to provide students with an introduction to current and future knowledge of strategic operations including Industry 4.0 and Smart Operations engineering and management in the context of a GMP environment. The module also aims to provide students with an understanding of various structured approaches to Risk Assessment and Management in the ATMP industry.

1. Describe the strategic importance of operations and how it relates to other business functions; evaluate performance objectives, product life cycle and the volume and variety effect and how these impact strategic decision making.

2. Demonstrate an awareness of the philosophy of operations excellence and Industry 4.0; analyse continuous improvement tools and datasets such as JIT, Lean, six sigma, statistical process control, error proofing and evaluate appropriate methodologies.

3. Apply Lean Six Sigma tools such as Value Stream Metrics, SMED, 5S,Visual Management, TPM, Kaizen Events, Creating Continuous Flow, Process Capability etc.

4. Discuss the regulatory requirements for risk assessment and management and interpret what is required to comply with these requirements.

5. Demonstrate use of problem solving (e.g. fishbone, 5 why etc) and risk management tools such as FMEA, HACCP etc. in a simulated scenario

This module is taken by Level 9 students enrolled on the MSc. in ATMP Manufacturing.

It aims to provide students with the background of Advanced Therapy Medicinal Products (ATMP) and how they differ to traditional biopharmaceuticals. In addition, the students will get an overview of the EU and US regulations that apply to ATMPs.

1. Discuss the nature and production of ATMP products

2. Describe ATMP manufacturing challenges, current and developing technologies, and quality control / quality affairs

3. Evaluate the global regulatory framework for biotechnology derived products

4. Differentiate the applications of EU & US regulations for ATMP marketing authorisations

5. Critically analyse EudraLex Volume 4 part IV and Annex I

This module is to be taken by Level 9 students enrolled on the Certificate in ATMP Vector Manufacturing / MSC in ATMP Technology and Manufacturing or the MSc in ATMP Manufacturing Development (60 credit thesis). It aims to provide students with the background in vector production, both viral and non-viral means. The biology, current and future vector systems will be covered to give students and overall understanding of the uses and importance of vector use for clinical outcomes. The course also focusses on the manufacturing and production process of vectors to ensure students have a complete understanding of the methods and reasons behind the challenges and steps required to supply demand.

1. Describe vector biology of common vector systems and differentiate between different vector systems for different applications.

2. Describe and evaluate the manufacturing, purification and formulation processes for viral vectors.

3. Examine existing and emerging non viral vector systems and describe manufacturing methods associated with these.

4. Evaluate manufacturing optimisation processes and critique new and emerging technologies

5. Propose relevant QC analytical test methods for different stages of vector production

This module is an introduction to the interdisciplinary field of tissue engineering and regenerative medicine using delivery systems. Essentially, new and functional living tissue can be fabricated by delivering cells, scaffolds, DNA and/or proteins at surgery. This course will introduce advances in the fields of material science, regenerative medicine and their relationship towards developing novel "cell, gene and tissue engineered" therapies.

1. Evaluate established and emerging natural and synthetic biomaterials for their uses in cell / gene delivery and as tissue engineering scaffolds

2. Compare efficacy of new and emerging polymer systems for gene and cell delivery, such as nanoparticles, lipid based systems, glycopolymers, smart polymers etc

3. Describe and analyse tissue engineered scaffold fabrication methods, and evaluate the role of bioreactors in cell / scaffold development

4. Demonstrate an appreciation of preclinical and clinical testing requirement and suggest suitable in vitro and in vivo test methods

5. Formulate hypotheses to treat existing clinical problems that would benefit from targeted delivery / tissue engineering approach and evaluate associated sustainability andethical concerns

The purpose of this module is to complete a research proposal which may subsequently form part of the MSc thesis. Students will have the opportunity to formulate a research topic, develop a research schedule and select appropriate methodologies for a research project. The learner will study different research methods, ethical considerations, learn how to critically analyse scientific documents, disseminate research in terms of reports, and communicate effectively.

1. Produce a research proposal document.

2. Undertake a focused literature search and generate a literature review on a research topic.

3. Select and apply an appropriate research methodology while adhering to ethical considerations.

4. Communicate effectively their research outcomes.

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