Clinical Trials Documents

ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturing

ST-018 ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturing v1.0.0 - PDF

This document provides instructions for the labeling of apheresis collection products for sponsor cellular therapy clinical trials and manufacturing.

 

ISBT 128 Standard Use of Clinical Trials Product Description Codes (PDCs)

ST-022 ISBT 128 Standard Use of Clinical Trials Product Description Codes (PDCs) v1.0.0 - PDF

This Standard provides guidance on the use of a new category of Product Description Codes (PDCs) specifically developed for clinical trials products. These Clinical Trials PDCs are standardized global identifiers allocated by ICCBBA, which may be used by organizations licensed with ICCBBA, including clinical trials facilities, clinical trial sponsors, and cell and gene therapy manufacturers.

 

Technical Bulletin TB-018

TB-018 - Labeling of clinical trial and manufactured cellular therapy (CT) final products using ISBT 128 - v1.0.0 PDF

This document helps users recognize various labeling scenarios that may apply to cellular therapy products.