Dermagraft/sup /spl reg// scale-up case study

Dermagraft/sup /spl reg// human fibroblast derived dermal substitute is a fibroblast cell based tissue, grown on a bioresorbable three-dimensional scaffold. At time of application, the product contains viable cells that are important for wound healing. Dermagraft/sup /spl reg// was developed primarily for the treatment of diabetic foot ulcers. The product had been developed for early clinical trials as single units. For commercial launch a scaled-up bioreactor and growth system were needed. It was desired that the bioreactor serve as the final package for delivery. Larger lot sizes were targeted at 1000 units. To achieve these goals, a new bioreactor was developed. This required a new concept to allow for multiple units. Bioreactor systems consisting of flexible plastic have been selected for the scale-up of the Dermagraft product. This system has the advantages of being used as the bioreactor for growth as well as the final container supplied to the customer. Additionally, there is no post-growth handling of the product to minimize the risk of contamination. The final product configuration meets all the customer requirements, including ease of usability, handling and application to the wound. It has been demonstrated that product yields in this scaled-up production system are sufficient to make the product commercially viable.