Manufacturing Development of Biomimetic Tissue Engineering Scaffolds

With tissue engineering science offering promising biomedical interventions for previously untreatable injuries or diseases, many researchers are investigating the use of nanofiber-based medical vehicles for regenerative medicine. The challenge is to produce such vehicles outside of a small-scale laboratory environment and to develop a GMP-compliant lab to fabricate medical-grade devices for use in clinical trials. This proposed effort is targeted towards developing a cGMP compliant electrospinning technology to produce small lots of tissue scaffold material. During Phase II, an electrospinning machine will be built in a Class 1000 clean room and a small lot manufacturing process used to produce a clinical grade PLGA tissue scaffold. Process parameters will be established for meeting GMP/GLP guidelines and regulatory protocols established for the master file for devices. The electrospinning machines capacity, capability, and performance will be determined to establish a design space, cost of goods sold, and economics for producing the scaffolds in small lots. Electrospun fiber size, web thickness, pore size, and mechanical properties will be controlled to meet the design specifications of the device. The facility will meet production capacity with varied capability to provide tissue scaffold material for clinical trials at military and civilian sites.