How do I initiate and maintain a mobile apheresis service in the era of cellular therapy.

BACKGROUND: Mobile delivery of apheresis services is an increasingly important component of health care equity, as patients should not have to transfer care providers or travel far distances to receive critical therapeutic apheresis procedures or cell therapy-based treatments. Therefore, the availability of such services should be expanded. STUDY DESIGN AND METHODS: In this "How Do I" article, we provide a detailed overview of the elements necessary to initiate and maintain a successful mobile apheresis service, including challenges and potential solutions. RESULTS: Safe and efficient operation of a mobile apheresis service must consider acquisition of physical assets, such as apheresis sites, personnel, equipment and supplies, communication devices, and transportation vehicles, and optimize organizational aspects, such as staff responsibilities, service partnerships, logistics management, case scheduling and triage, and billing. In the era of cellular therapy, additional critical considerations include regulatory compliance and facility accreditation. DISCUSSION: To our knowledge, no previous publication provides the extensive details described herein to set up and maintain a successful mobile apheresis service, and thus will be very helpful to those facilities wishing to initiate or expand mobile apheresis services.

Potentially modifiable predictors of cell collection efficiencies and product characteristics of allogeneic hematopoietic progenitor cell collections.

BACKGROUND: Hematopoietic progenitor cell (HPC) and immune effector cell (IEC) therapies often require high doses of mononuclear cells (MNCs), whether CD34+ cells, lymphocytes, or monocytes. Cells for IEC can be sourced from HPC products. We thus examined potentially modifiable variables affecting collection efficiencies (CEs) of MNC subsets in HPC collection and also of the typically undesired cell types of platelets, granulocytes, and red cells, which hinder downstream processing. Finally, we sought to confirm previously indeterminate studies of the effect of an adjusted collect flow rate (CFR) on CD34+ CE. STUDY DESIGN AND METHODS: We performed univariate and multivariate regression analyses of all 135 National Marrow Donor Program (NMDP) HPC collections in 2019 and compared these fixed CFR procedures to previous NMDP collections using adjusted CFRs. RESULTS: Target cell CEs decreased with increasing peripheral blood (PB) concentration and were associated with different cell type locations within the MNC layer. CEs of undesired cell types varied with standard procedural parameters (inlet flow rate, whole blood processed, etc.). Interestingly, some CEs increased with preapheresis hematocrit. Finally, adjusting the CFR by PB MNC count improved MNC CE but not CD34+ CE. CONCLUSION: Correlation of target cell CEs with their PB concentration and different cell type locations by depth within the MNC layer indicates the importance of investigating the compensatory fine-tuning of procedure variables to improve CE. Correlation of CEs with PB hematocrit, and CFR adjustment by a modified PB MNC and/or PB CD34 algorithm should be further explored. Adjusting standard procedural parameters may reduce product contamination.

A dual strategy to optimize hematopoietic progenitor cell collections: validation of a simple prediction algorithm and use of collect flow rates guided by mononuclear cell count.

BACKGROUND: Previous prediction algorithms to achieve target CD34+ goals have not been widely adopted, with many centers still using a set volume to process for hematopoietic progenitor cell collections. This may be because previous algorithms are challenging to implement. Additionally, no study has yet examined the utility of adjusting the collect flow rate (CFR) based on the donor's preprocedure total mononuclear cell (MNC) count, which correlates with CD34+ yield. STUDY DESIGN AND METHODS: In this retrospective analysis of mobilized allogeneic donors collected using MNC (COBE Spectra, Terumo BCT) or continuous mononuclear cell collection (CMNC) (Spectra Optia, Terumo BCT) procedures, we validated a one-step prediction algorithm to achieve the target CD34+ product dose (Appendix S1, available as supporting information in the online version of this paper). The COBE Spectra MNC Collect Flow Tool (Appendix S2, available as supporting information in the online version of this paper) was used to select the collect flow rate for both MNC and CMNC procedures. Procedural collection efficiency (CE) was compared to that of historical procedures utilizing fixed CFRs (1.0-1.5 mL/min). RESULTS: Ninety-three percent of collections achieved the target CD34+ goal using our algorithm-calculated process volumes. The remaining 7% of cases had CEs lower than the algorithm CE (0.40), and thus were below goal. Second, an MNC-based CFR improved MNC and CD34+ CEs in patients with higher MNC counts compared to our historical controls. CONCLUSION: We validated that this simple, single-step prediction algorithm achieves the target CD34+ goal in most HPC collections. Secondly, we showed that an MNC-based CFR for hematopoietic progenitor cell collections improves CE at higher MNCs; this may be preferable to a WBC-based CFR because of variability of MNC counts at a given WBC count.