This module will provide an understanding of the requirements, opportunities and constraints of advanced therapy manufacturing practice, taking into account biosafety and current Good Manufacturing Practice regulations (cGMP) considerations.

It will introduce concepts such as Quality by Design, Design of Experiments and Lean Six Sigma and expose students to the industrial aspects of stem cell and gene therapy production. The module will explore clinically-relevant products including a range of cell types including adult and pluripotent stem cells, blood and progenitor cells and gene-modified cells, focusing on their manufacturing process design and quality control. The relevant technology platforms used for therapy production will be identified and discussed. The module will also provide students with commercial and industrial exposure through visits to relevant facilities (e.g. Cell and Gene Therapy Catapult), companies (e.g. Oxford Biomedica) and/or conferences.

On completion of this module, students will be able to:

Recognise and appraise current and potential future states and limitations of advanced therapy manufacture, with both a national and international context
	Discuss the requirements, complexities and opportunities to enable manufacture of stem cell and gene therapies.
	Understand and implement the concepts of Lean and Six Sigma for conventional manufacturing industries and the role of Quality by Design and Design of Experiments for biological manufacture.
	Conceptualise and communicate the impact and role of different manufacturing technologies and strategies for ATMP production
	Understanding and discuss the role of fundamental biosafety, cGMP and containment measures for biomanufacture of ATMPs
	Analyse and evaluate research literature, commercial findings and industry datasets to devise appropriate manufacturing processes for stem cell and gene therapy applications.
	Evaluate and adapt existing biomanufacture strategies to improve process and product yield, quality and/or safety.
	Conceptualise and communicate the impact and role of different manufacturing technologies and strategies for ATMP production