The US Pharmacopoeial Convention (USP) and International Society for Cellular Therapy (ISCT) are hosting a two-day workshop on “Cell and Tissue-based Regenerative Medicine Products: From Characterization to Compendial Assays” on November 7 and 8, 2013 at the USP headquarters in Maryland.

The workshop will feature two days of presentations covering new horizons for regenerative medicine products; case studies illustrating challenges with cell- and tissue-based therapies; characterization of regenerative medicines; chemical and physical testing; potency testing; and the development of standards.

By bringing together stakeholders from industry, academia and the regulatory community, USP and ISCT will gather feedback on best approaches to quality standardization for a wide variety of cell- and tissue-based products. Input from workshop participants will help USP identify and prioritize topics that have the potential to lead to standards published in the United States Pharmacopeia - National Formulary(USP–NF), USP’s compendia of quality standards for medicines and their ingredients.

Experts present at the two day workshop includes: Dr Michelle Williams, chief scientific officer, Osiris Therapeutics, Inc., and Dr Carl June, professor in immunotherapy at the Perelman School of Medicine, University of Pennsylvania.

The workshop sessions will also include speakers from Athersys; Organogenesis; Dendreon; the McGowan Institute of Regenerative Medicine; University of California, Santa Barbara; the US Food and Drug Administration; and the National Institute of Biological Standards and Control.