Moving into the clinic

Abstract Tissue engineering ensures the repairing or replacement of diseased organs and tissues for many patients to be promising. Although the field is relatively young, many innovative and exciting research have begun to transfer to the clinic. Translation of tissue-engineered products usually follows similar procedures as regular drug products. Once proof of concept is established for a tissue engineering project, preclinical studies are conducted, followed by process and product development for human use. Once routine processing is established, it gets transferred to a manufacturing team to produce the product in a current good manufacturing practice facility. Subsequently, the product testing is performed by quality control, and quality assurance provides the structure for documentation and oversight to processing, testing, and facility management. The translation into the clinic is guided by FDA regulations. Traditional FDA regulations for drug products are being shifted to be specific to tissue engineering products, and understanding of the latest regulations is essential for a successful translation into the clinic.