ABSTRACT
The evolving technologies and advances in the engineering biosciences are expected to have significant impact in the fields of pharmaceutical engineering (drug production, delivery, targeting, and metabolism), molecular engineering (biomaterial design and biomimetics), biomedical reaction engineering (microreactor design, animal surrogate systems, artificial organs, and extracorporeal devices), and metabolic process control (receptor-ligand binding, signal transduction, and trafficking). Since understanding of the cell/tissue environment will help produce major developments in all of these areas, the ability to characterize, control, and ultimately manipulate the microenvironment is critical. The key challenges, as identified by many sources [Palsson, 2000], are (1) proper reconstruction of the microenvironment for the development of tissue function, (2) scale-up to generate a significant amount of properly functioning microenvironments to be of clinical importance, (3) automating cellular therapy systems/devices to operate and perform at clinically meaningful scales, and (4) implementation in the clinical setting in concert with all the cell handling and preservation procedures required to administer cellular therapies. The direction of this chapter is toward supporting efforts to address these issues. Thus, the primary objective is to introduce the fundamental concepts needed to reconstruct tissues ex vivo and produce cells of sufficient quantity that maintain stabilized performance for extended time periods of clinical relevance. The delivery of cellular therapies, as a goal, was selected as one representative theme for illustration.
