Five Critical Areas that Combat High Costs and Prolonged Development Times for Regenerative Medicine Manufacturing

Purpose of Review: The purpose of this review is to examine five stages of process improvement in bioengineering of cellular products that could facilitate standardization and accelerate progress through the regulatory pathways and together make such treatments more widely available. Recent Findings: We present solutions to reduce costs, promote standardization, and enable acceleration through the required regulatory pathways. Summary: Regenerative medicine-based technologies and products have the potential to revolutionize the practice of medicine and become the next standard of care. We identify current barriers that are limiting the widespread availability of these potential life-saving treatments and platform technologies. One central barrier is the cost of manufacturing these regenerative medicine-based technologies and products at commercial scale.