White Paper: Licensing Your Cord Blood

A Guide to Getting FDA Approval for Marketing your Public Bank’s Lifesaving Product as a Prescription Drug

Hematopoietic progenitor cell, cord blood is being utilized to treat a number of medical conditions, with tremendous hope for many more groundbreaking treatments to come. Most cord blood units (CBU) available for therapeutic use today are categorized as investigational new drugs (IND). However, a handful of public cord blood banks are pursuing or have received FDA licensure. This allows cord blood to be sold as a prescription drug—known as HPC, Cord Blood—on the consumer market. HPC, Cord Blood is sold the same way any prescription drug is sold.

The license application process can be arduous and time consuming, especially if completed manually, but the expectation is that cord blood products subjected to this rigorous procedure will be of higher quality and will improve transplant outcomes.

What You Will Learn

  • Financial benefits of licensing your cord blood products
  • Hurdles to achieving prescription drug status
  • Guidelines and processes for completing the biologics license application

Fill out the form on the right to download the Licensing Your Cord Blood white paper.