Commercial development of cell-based therapeutics: strategic considerations along the drug to tissue spectrum.

In cell-based therapy, the process defines the product and the biological interaction between implant and host determines the outcome. Developing the optimum combination of process, product and a clinically relevant effect has been a challenge, leaving many potential therapies stalled in early clinical studies. This special report discusses pivotal factors in the development of cell-based technologies, irrespective of where they fit on the spectrum from cell-based drug to tissue construct, and how we can ensure delivery of an effective product to the clinic and the marketplace. Epidermal cell-based therapies serve as an historical lesson.