The U.S. National Institute of Standards & Technology (NIST) is among the organizations rising up across the industry/government/academia spectrum to support the complex “ecosystem of capabilities” needed to develop, manufacture and deliver cell and gene therapies (CGTs).
NIST Biosystems and Biomaterials Division Chief Anne Plant had a chance to explore the challenges that exist in creating this ecosystem and NIST’s role in helping facilitate the standards development and public/private cooperation needed to address them at the opening session of CASSS’ summer 2017 CMC strategy forum.
Held in Gaithersburg, Maryland in July, the two-day forum helped contribute to the growing understanding of the “many technical, practical and regulatory” challenges involved in CGT development. The forum was divided into four workshop sessions addressing: ● analytical methodologies and specifications ● comparability ● manufacturing strategies, and ● raw materials and the supply chains.
Plant’s presentation at the opening methods/specs session provided a strong foundation for the forum discussions that ensued. The expanding field of regenerative medicine, she stressed, includes “a whole lot of participants” and demands “an ecosystem of capabilities” to create the therapies and support their production with ancillary materials, equipment and instrumentation. “It is a very complex space with a lot going on.”