The challenge of raw material variability and strategies for standardization

The advancement of cell therapies depends on the success of industry-wide efforts to reduce variability in source materials, manufacturing processes, and analytical strategies. A newly-published paper in Regenerative Engineering and Translational Medicine identifies several sources of variability throughout the cell therapy supply chain, manufacturing process, and release testing, and identifies standardization efforts, automation strategies, and

The Importance of Standards and Manufacturing Needs – Recent Meetings

On Monday, March 18, the Standards Coordinating Body convened for a workshop on standards. The group discussed how standards are critical for the transfer of novel technologies from academia to clinical use. The FDA’s Judy Arcidiacono, one of the keynote speakers, discussed how standards are imperative to building the foundation of regenerative medicine innovation. The

SCB Perspectives: ISO Publishes Three-Part Documentary Standard on Ancillary Materials for Cell Manufacturing Processes

This blog post was originally shared at standardscoordinatingbody.org. Claudia Zylberberg, SCB Board Member, Akron Biotech December 17, 2018 I’m pleased to announce that one of the first standards advancement projects SCB was involved in, Ancillary Materials Used in Cellular Therapy Production, has culminated in the publication of a three-part documentary ISO standard (ISO/TS 20399): Part

Akron remains committed to our regenerative medicine partners, both domestic and international

The recent EMA recommendation for approval of Kymriah and Yescarta serves as yet another sign of the commercial arrival of cell therapies and their growing global appeal. As these novel therapeutics expand beyond US boundaries, Akron has taken the following steps to help our clients better understand the regional regulatory differences, innovations and tools available