Banking Methods
The FDA governs the collection, processing, storage, labeling, packaging, and distribution of cord blood stem cells. There are two different standards which can apply: cGTP (current Good Tissue Practices) and cGMP (current Good Manufacturing Practices). cGTP standards apply to the collection, processing and storage of human cells, tissues, and cellular/tissue-based products (HCT/Ps) and are regulated by the Center for Biologics Evaluation and Research. All US cord blood banks must be compliant with cGTP standards. cGMP standards apply to the manufacture of a product that is considered a drug. How one determines whether a bank must be compliant with cGMP standards is based upon the product that they manufacture. If a cord blood bank manufactures cord blood stem cells that are overly manipulated or the cells are used in a different basic biologic function, that product is regulated as a drug, and both cGTP and cGMP standards would apply. If a cord blood bank manufactures cord blood stem cells that are minimally manipulated and the cells are used for the same basic biologic function and/or for use in people that are 1st or 2nd degree blood relatives, that product is regulated solely under cGTPs.
cGTP standards are based upon cGMP standards, and thus there are many similarities.
Read more about this topic: Cord Blood Bank
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