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 preclinical studies and ultimately facilitating effective commercialization of engineered clinical products.