Leukocytapheresis in nonmobilized donors for cellular therapy protocols: Evaluation of factors affecting collection efficiency of cells

Abstract

Introduction Collection efficiency (CE1) of cells refers to the number of cells that are collected from the total number of cells processed by the apheresis device. Limited data are available about the CE1 of cells when performing leukocytapheresis in nonmobilized donors for cellular therapy purposes. The aim of our study was to evaluate donor‐ and procedure‐related characteristics that might influence the CE1 of cells. Material and Methods Variables that predicted the CE1 of cells were analyzed by longitudinal linear regression in a series of 1071 leukocytapheresis procedures on 249 nonmobilized donors. Donor‐related characteristics considered were gender, age, total blood volume, and complete blood count (CBC) data. Procedure‐related characteristics considered were vascular access and device used. Results Older donor age was associated with a decrease in the CE1 of leukocytes, lymphocytes, monocytes, and mononuclear cells (MNCs; sum of leukocytes and monocytes) and with an increase in the CE1 of platelets (P < .05). Preprocedure CBC data (leukocytes, lymphocytes, monocytes, and platelets) were associated with either a statistically significant increase or decrease in the CE1 of cells. Central line used as vascular access was associated with a statistically significant decrease in the CE1 of MNCs (P = .02). Conclusion Donor's age, preprocedure CBC data as well as central line used as vascular access were factors associated with CE1 of cells. Knowing these characteristics is helpful in the apheresis unit when designing cellular therapy protocols in order to maximize the CE1 of the desired cell and to personalize collection variables for each donor.

Evaluation of cell collection efficiency in non‐mobilized adult donors for autologous chimeric antigen receptor T‐cell manufacturing

“…In a previous study, our group observed that collection of cells using a central line was associated with lower CE1 of MNCs [10].…”

“…Adverse events during apheresis, such as hypotension, bleeding, symptomatic hypocalcaemia or allergic reactions, were collected from medical records. TBV to process was calculated, either using the CE1 formula previously reported by our group [10]…”

Increased collection efficiency of CD34+ cells after mobilization with preemptive use of plerixafor followed by leukocytapheresis on the same day

“…Experienced apheresis nurses followed the manufacturerʼs instructions to perform apheresis procedures as previously reported . Mononuclear cell collection with an apheresis device (Cobe Spectra, TerumoBCT) was used from 2007 to 2015, and continuous mononuclear cell collection with a different apheresis device (Spectra Optia, TerumoBCT) was used from 2016 onwards.…”

“…Experienced apheresis nurses followed the manufacturerʼs instructions to perform apheresis procedures as previously reported. 13 Mononuclear cell collection with an apheresis device (Cobe Spectra, TerumoBCT) was used from 2007 to 2015, and continuous mononuclear cell collection with a different apheresis device (Spectra Optia, TerumoBCT) was used from 2016 onwards. The quantity of blood to process was calculated to obtain a target of 2 × 10 6 /kg CD34+ cells with use of the CD34+ cell count in peripheral blood sampled immediately before starting the apheresis procedure and the historical CE1.…”

Providing the Starting Material to the Manufacturer of an Approved and Commercially Available Autologous CAR-T Cell Treatment

“…Depending on the platform selected, the characteristics of the product collected might vary significantly. For instance, if an Amicus separator (Fresenius-Kabi, Bad Homburg, Germany) is used, the platelet content is very low in comparison to Spectra Optia (Terumo BCT, Lakewood, CO, USA) (Cid et al 2019), see Table 6.3. -Check if the total blood volume of the patient requires priming of the apheresis separator.…”