What You Need to Know About: Research Grade Leukapheresis Products
Friday, April 26, 2019
What Are Research Grade Leukapheresis Products?
Leukapheresis Products that are Research Grade refers to HCT/P (human cells, tissues, and cellular and tissue-based products) intended for in vitro or laboratory use only. No part or component of the HCT/P can be used clinically in humans.
As with our leukapheresis products for clinical use, blood center volunteer donors are the donors for our research grade leukapheresis products. Although research grade leukapheresis products are not used clinically, our cellular therapy collection process for these HCT/P remains compliant in all respects with the FDA Code of Federal Regulations (CFR) Part 1271. Because FDA eligibility criteria differ in some respects between blood donors and HCT/P donors, blood donors who meet FDA eligibility for blood donation may not necessarily meet FDA eligibility criteria to donate HCT/P. If the requesting organization approves collection from an ineligible donor, however, the donor can still be collected as long as s/he meets donor safety criteria for collection. Donor safety (also referred to as donor suitability) refers to the safety of the collection for the donor, in contrast to donor eligibility, which assesses the risk of potential transmission by the donor of a relevant infectious disease to the recipient. When possible, requests for leukapheresis products from donors with specific characteristics, such as age, gender, ethnicity, CMV status, and HLA type, are also met.
Two types of research grade leukapheresis products are available: mobilized or non-mobilized. The purpose of mobilization is typically to collect hematopoietic stem cells. The mobilization agent used can be either G-CSF or plerixafor. Non-mobilized products are typically collected to obtain cells such as lymphocytes, monocytes, and dendritic cells. In both cases, the apheresis device is programmed to collect mononuclear cells.
It is helpful for the requesting organization to communicate the target total number of lymphocytes, monocytes, or CD34+ cells for collection. Otherwise an absolute number of liters or donor total blood volumes to process should be specified. The requesting organization should also specify the target product hematocrit and whether concurrent plasma is required, and whether to collect it into the product bag or a separate plasma bag. Finally, our cellular therapy processing facility may be able to assist in any further manipulation of the product desired.
Dr. Shi's research team is focused on translational research in sickle cell disease, cellular therapy aspects of sickle cell disease, such as plerixafor mobilization of hematopoietic stem cells for gene therapy and autologous cord blood characteristics. A list of her publications can be found here.