Cell Therapy Manufacturing Facility: Design and Operation

Recently a great interest has arisen in the field of cell therapy products(CTPs) manufacturing. According to the current international standardsthe CTPs should be manufactured under principles of good manufacturingpractices (GMP). GMP is fundamental to product safety and quality andto involve multiple elements covering all aspects of production. Althougheach element is equally important, the facility is the most obvious andtangible aspect of GMP. There are few specific regulatory requirementsfor CTPs; consequently, GMP for pharmaceuticals and biologics shouldbe applied. The objective of this presentation is to summarize the basicrequirements for CTPs manufacturing facilities and provides an overviewof facility planning and design, cleanroom classifications, and operation.

Keywords:

Cell therapy , Clean room , GMP , Regenerative medicine , Regulation