UPDATE: DRAFT PUBLICATION OPEN FOR COMMENTARY

"Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing"




The Deloitte Next Generation Therapies Industry Working Group Meeting in September 2019 identified the need to focus on standardization of labeling of collection products for cell therapy manufacturing for clinical trials.

Based on this, a decision was made to establish a focus group comprised of industry stakeholders and facilitated by the Standards Coordinating Body to work on standardizing the minimum elements required for labeling. A draft standards document is the initial output from the focus group and is being circulated for comment. Comments should be submitted to: Dawn Henke of the SCB (dhenke@regenmedscb.org) by April 24th.


Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing - Draft

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