Standards for Cellular Therapy Product Services

In 2002, the AABB Board of Directors created a standards program unit specifically charged with drafting a set of ¨Standards to encompass all areas of cellular therapy, including HPC, cord blood, and somatic cell activities. The intent of creating a single set of Standards addressing these three types of cellular therapy products is to minimize the need for redundant assessments of facilities that are involved in the procurement, processing, storage, or issue of more than one type of cellular therapy product. This book is formatted according to the Core 10 quality template. Both the Standards for Hematopoietic Progenitor Cell and Cellular Product Services, 3rd edition, and the Standards for Cord Blood Services, 1st edition utilized a 20 chapter format, known as the Core 20 template. The Core 10 template contains the same language as the Core 20 template, although it relies on a 10-chapter structure that mirrors the Quality System Essentials (QSE). In addition to this change in the formatting of Standards, there are several new technical requirements in the Standards for Cellular Therapy Product Services, 1st edition.