DRAFT STANDARDS DOCUMENT OPEN FOR PUBLIC COMMENT

Updated: Sep 10


A draft Standard, Labeling of Collection Products for Cellular Therapy Manufacturing, is now available for public comment. The new standard was designed to address inconsistencies in labeling apheresis collection products that are being used in cellular therapy manufacturing and was developed in collaboration with industry partners including bluebird bio, GlaxoSmithKline, Gilead Sciences, Johnson & Johnson, Juno Therapeutics, Kite Pharma, Legend Biotech, National Marrow Donor Program (NMDP/Be The Match), Deloitte, AABB, FACT, Standards Coordinating Body for Regenerative Medicine, TrakCel, Vineti, and subject matter experts in apheresis nursing and quality assurance. The standard aims to reduce the risk of misinterpretation of patient data while providing consistency in labeling requirements to collection centers.

This draft builds on the existing ISBT 128 standards for cellular therapy and is a supplement to the ISBT 128 Standard Technical Specification (ST-001). Essential ISBT 128 traceability information is retained, while also accommodating sponsor/manufacturer information in a standardized manner. It defines the labeling requirements for cellular therapy apheresis collection products for further processing by a clinical trials sponsor or a manufacturer. It is for use only in situations where the sponsor/manufacturer has adopted this standard and has provided the necessary information to populate the sponsor/manufacturer section of the label. While designed for apheresis collection products, the use of the label on collection products for further processing from other sources is not prohibited. Future versions of this standard may be extended to cover other sources of collection products.

We encourage you to review the draft Standard and provide any input you may have.

Please submit your comments by October 18, 2020.

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