Abstract
This article reviews some of the considerations and unforeseen challenges with sourcing and preparing regulatory filings using donor supplied Hematopoietic stem cells (HSCS) in novel allogeneic cell and gene therapies. There are unique complications not seen with autologous therapies as developers must understand the regulatory requirements for donor sourcing, testing and isolation of CD34+ cells for IND submissions. Finding the right partner for sourcing as well as lot release testing is discussed. Understanding the procurement requirements for the starting cells and the manufacturing process used is reviewed. This article covers some of the areas that organizations may miss when developing these types of cell and gene therapy products for the first time.
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