ESS Summary Clause Samples

ESS Summary. The product is an engineered skin substitute (ESS) consisting of autologous skin cells within a degradable biopolymer substrate. Isolated epidermal keratinocytes and dermal fibroblasts are cultured in nutrient media to promote population expansion. The cells are separately seeded onto a biopolymer substrate fabricated from collagen and carbohydrate polymers (glycosaminoglycan). The ESS device has been shown in preclinical studies to generate a functional skin barrier and in clinical studies to promote closure and healing of ▇▇▇▇▇. This is the only medical device known at present for the treatment of full-thickness ▇▇▇▇▇ with autologous cells combined with a polymeric substrate. With extensive cell therapy expertise and manufacturing capabilities, Lonza is well positioned to produce ESS at the Walkersville, MD facility. Based on yields generated during engineering runs and development runs, it is projected that cells isolated from a 30-40 cm2 biopsy, would generate an approximate yield of 3600 cm2 per lot of ESS material. Production of ESS would be staggered using two lots to produce enough product per patient in 6-8 weeks.