Regenerative medicine bioprocessing: building a conceptual framework based on early studies.

This paper reviews early studies of regenerative medicine using human cells and engineered tissues progressing from a laboratory-centered manual procedure toward automated manufacture. It then examines the distinctive bioprocesses by which autologous human material must be produced, the degree of simplification allowed by use of allogeneic cell lines and engineered tissue derived from them, and issues that affect both cell types. The paper concludes by drawing upon this discussion to suggest some factors that will determine how regenerative medicine bioprocessing can progress to provide many units of material economically.