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New Public-Private Partnership to Develop Standards for Regenerative Medicine

Retinal Pigment Epithelium  on nanofiber scaffold

Scanning electron micrograph of retinal pigment epithelium (RPE) cultured on a nanofiber scaffold. RPE and nanofibers were imaged separately and combined. There are two scale bars since RPE and nanofibers were imaged at different magnifications. Nanofibers were pseudocolored and shadowing was added to the RPE

The National Institute of Standards and Technology has partnered with the Standards Coordinating Body for Gene, Cell and Regenerative Medicines and Cell-based Drug Discovery (SCB) to develop industry-wide standard methods and protocols for characterizing and manufacturing these cutting-edge therapies, with an aim of accelerating their use as mainstream treatments for a variety of human diseases and injuries.

The field of regenerative medicine manipulates genes, cells, and tissues to repair or replace diseased, damaged, or missing organs, skin, bone, and other cells and tissues. Regenerative medicine has the potential to alleviate the shortage of donor organs and restore appearance and full function to patients who have experienced severe burns or physical trauma.

Because of the complexity of regenerative medicine treatments, they have been slow to transition from the laboratory to the clinic. The traditional measurements of efficacy, potency, purity, and quality that work with traditional pharmaceuticals aren’t always sufficient for regenerative medicine treatments.

To address these issues, NIST and the SCB, a non-profit founded by the Alliance for Regenerative Medicine, announced on September 19, 2016 that they had signed a Memorandum of Understanding, forming a partnership to explore the regenerative medicine industry’s needs and develop standards and other products to increase confidence in measurements of gene- and cell-based therapies and manufacturing processes.

To learn more about the partnership, SCB, or the Alliance for Regenerative Medicine, see their press release.

To learn more about the Regenerative Medicine Biomanufacturing program in NIST’s Biosystems and Biomaterials Division, click here.

Released October 26, 2016, Updated August 31, 2018