Document for Review - Labeling of Collection Products for Cellular Therapy Manufacturing

User: briana
Date: 9/4/2020 11:54 am
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Labeling of Collection Products for Cellular Therapy Manufacturing - Draft

This draft Standard is being put out for public consultation and was developed by ICCBBA in collaboration with industry partners including: bluebird bio, Glaxo Smith Kline, Gilead Sciences, Johnson & Johnson, Juno Therapeutics, Kite Pharma, Legend Biotech, National Marrow Donor Program (NMDP/Be The Match, Deloitte, AABB, FACT, Standards Coordinating Body, Trakcel, Vineti, and subject matter experts in apheresis nursing and quality assurance.

The draft Standard builds on the existing ISBT 128 standards for cellular therapy and uses compatible label dimensions. It retains the essential ISBT 128 traceability information while also accommodating sponsor/manufacturer information in a standardized manner. It is a supplement to the ISBT 128 Standard Technical Specification (ST-001). 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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