Bioreactor-based roadmap for the translation of tissue engineering strategies into clinical products.

Despite the compelling clinical need to regenerate damaged tissues/organs, impressive advances in the field of tissue engineering have yet to result in viable engineered tissue products with widespread therapeutic adoption. Although bioreactor systems have been proposed as a key factor in the manufacture of standardized and cost-effective engineered products, this concept appears slow to be embraced and implemented. Here we address scientific, regulatory and commercial challenges intrinsic to the bioreactor-based translation of tissue engineering models into clinical products, proposing a roadmap for the implementation of a new paradigm. The roadmap highlights that bioreactors must be implemented throughout product development, allowing scientific, medical, industrial and regulatory parties to address basic research questions, conduct sound pre-clinical studies and ultimately facilitating effective commercialization of engineered clinical products.