There are many unique challenges related to the development, manufacture and commercialization of stem cell and other cell-based therapeutic and regenerative medicine products.The presentation will address requirements related to process development and scale-up of manufacturing and quality control procedures for production of stem cell and other cell-based therapeutics under cGMP requirements.The presentation will focus on manufacturing process development, cGMP requirements, documentation, and sourcing of tissue to meet cGTP requirements, etc.Product requirements such as development of methods for product characterization for safety, purity, potency, and reproducibility and reliability of cell-based products will be discussed.Additional critical areas such as other appropriate quality control testing methods, manufacturing environment and facilities requirements will also be addressed including often overlooked items which are key regulatory requirements/considerations.These items include: process validation; reagent selection, reagent and product stability studies; raw materials procurement/management; product storage, shipping, and treatment center preparation and delivery of cell-based products.