Abstract
The regulatory requirement to demonstrate purity and potency presents a much bigger challenge to regenerative medicine compared with small-molecule drugs and protein biologics because of the desire to introduce living cells into the human body. Any cell population is inherently heterogeneous and bioresponsive - characteristics that make standardization by traditional methods extremely difficult. Standardization is on a 'critical path' to demonstrating purity and potency as I will discuss. Although difficult, I believe standardization is not impossible. In fact, I believe untapped resources of benefit to the regenerative medicine and cell therapy industries exist, particularly in the area of oncology molecular diagnostics. Leveraging the vast amounts of cellular biomarker data that are linked with clinical outcomes and the established reimbursement strategies generated by oncology product development efforts might accelerate the translation of regenerative medicine products from the bench to the clinics both scientifically and financially.
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