Scientific Publications by FDA Staff

Tissue Eng Part B Rev 2009 Dec;15(4):381-94

Developmental Engineering: A new paradigm for the design and manufacturing of cell based products. Part I: From three-dimensional cell growth to biomimetics of in vivo development.

Lenas P, Moos M Jr, Luyten FP

Recent advances in developmental biology, systems biology, and network science are converging to poise the heretofore largely empirical field of tissue engineering on the brink of a metamorphosis into a rigorous discipline based on universally-accepted engineering principles of quality by design. Failure of more simplistic approaches to the manufacture of cell-based therapies has led to increasing appreciation of the need to imitate, at least to some degree, natural mechanisms that control cell fate and differentiation. The identification of many of these mechanisms, which in general are based on cell signaling pathways, is an important step in this direction. Some well-accepted empirical concepts of developmental biology, such as path-dependence, robustness, modularity, and semi-autonomy of intermediate tissue forms that appear sequentially during tissue development are starting to be incorporated in process design.