Organ Chips: Quality Assurance Systems in Regenerative Medicine

Abstract

A class of novel therapies leverages regenerative cell types in disease microenvironments. This complex interplay challenges established good manufacturing practices, as standards and analytical tools to measure regenerative potency are missing. That is, we can build the product right, but we do not know if we are building the right product. Here, we suggest that organ‐chips, biomimetic in vitro phenotyping platforms, can serve as key quality assurance systems in regenerative medicine.

Regenerative medicine curriculum for next-generation physicians

“…Furthermore, exposure to Current Good Manufacturing Practice (cGMP) allows students to learn how standardized and scalable regenerative products are generated compliant with regulations for clinical-grade manufacturing, quality control/assurance, and delivery. 33–35 Other regenerative technologies and resources included exposure to the bio-insurance principle realized in the biobanking/biotrust platform, product/process development encompassing tissue engineering and (a)cellular regenerative biotherapies, and innovator/entrepreneurial pathway. At the course conclusion, next-generation physicians learned how to incorporate regenerative strategies into future clinical training and understand the steps of discovering, perfecting, and building through scale-in/scale-out paradigms.…”

Managing Innovation to Maximize Value Along the Discovery‐Translation‐Application Continuum

“…Moreover, there are 704 companies in the field of regenerative medicine with more than half in the United States . However, like other drug development paradigms referenced above, development of regenerative medicine therapies is being hampered by a number of systemic limitations, as described by Allickson, Abou‐El‐Enein et al ., and Pasqualini et al . Thus, partnerships are essential, with the emerging shifts in industry that focus on academia for innovation .…”

“…However, like other drug development paradigms referenced above, development of regenerative medicine therapies is being hampered by a number of systemic limitations, as described by Allickson, Abou‐El‐Enein et al ., and Pasqualini et al . Thus, partnerships are essential, with the emerging shifts in industry that focus on academia for innovation . Early collaborations with regulatory agencies can help facilitate progress in development, given their intimate knowledge of regulatory strategies and pathways .…”

“…Developing novel paradigms for manufacturing these unique cell‐based therapies will be essential to enable the broadest distribution of these revolutionary modalities to the widest segment of the global population . Moreover, evolving novel in vitro biomimetic platforms can provide comprehensive model systems to ensure quality control for optimal performance in therapeutic applications …”

Clinical Pharmacology & Therapeutics: Past, Present, and Future

“…Macroscopy continues to remind us that our discipline impacts, and is impacted by, the larger canvas of geopolitical, socioeconomic, and environmental issues that bind us in a global community. The latest innovations in molecular, clinical, and regulatory sciences are showcased in Opinion pieces, including Discovery, Translation, and Development . Moreover, State of the Art and Reviews offer authoritative synthesized content, reflected by their high rate of citations, providing in‐depth analysis of emerging trends in the practice of clinical pharmacology.…”