Abstract
Cell separation technologies play a vital role in the graft engineering of hematopoietic cellular fractions, particularly with the rapid expansion of the field of cellular therapeutics. The CliniMACS Plus Instrument (Miltenyi Biotec) utilizes immunomagnetic techniques to isolate hematopoietic progenitor cells (HPCs), T cells, NK cells, and monocytes. These products are ultimately used for HPC transplantation and for the manufacture of adoptive immunotherapies. We evaluated the viable cell recovery and cell purity of selections and depletions performed on the CliniMACS Plus over a 10-year period at our facility, specifically assessing for the isolation of CD34+, CD4+, CD3+/CD56+, CD4+/CD8+, and CD25+ cells. Additionally, patient- and instrument-related factors affecting these parameters were examined. Viable cell recovery ranged from 32.3 ± 10.2% to 65.4 ± 15.4%, and was the highest for CD34+ selections. Cell purity ranged from 86.3 ± 7.2% to 99.0 ± 1.1%, and was the highest for CD4+ selections. Undesired cell fractions demonstrated a range of 1.2 ± 0.45 to 5.1 ± 0.4 log reductions. Red cell depletions averaged 2.12 ± 0.68 logs, while platelets were reduced by an average of 4.01 ± 1.57 logs. Donor characteristics did not impact viable cell recovery or cell purity for CD34+ or CD4+ cell enrichments; however, these were affected by manufacturing variables, including tubing size, bead quantity, and whether preselection platelet washes were performed. Our data demonstrate the efficient recovery of hematopoietic cellular fractions on the CliniMACS Plus that may be optimized by adjusting manufacturing variables.
Highlights
The therapeutic value of individual cellular components of blood has been recognized since the 1950s, when the first developed blood cell separators paved the way for “component therapy” from whole blood, comprising segregated red cells, platelets, granulocytes, or plasma[1,2,3]
viable cell recovery (VCR) or selection efficiency was in the range of 32.3 ± 10.2% to 65.4 ± 15.4%, and was the highest for CD34+ cell selections (Table 2, Figure 2)
At our cell processing facility, the CliniMACS Plus has been used for this purpose for more than 10 years in over 50 investigational new drug protocols
Summary
The therapeutic value of individual cellular components of blood has been recognized since the 1950s, when the first developed blood cell separators paved the way for “component therapy” from whole blood, comprising segregated red cells, platelets, granulocytes, or plasma[1,2,3]. Cellular subfractions of blood and bone marrow, including CD34+ hematopoietic stem and progenitors, T-cell subsets, NK cells, and monocytes can be safely and consistently isolated and enriched for therapeutic use in hematopoietic stem cell transplantation, graft versus host disease Pdf_Folio:161. A variety of cell separation methods is currently available for clinical use These methods take advantage of cell characteristics such as adherence, density, and/or antibody binding [4]. Of the antibody binding methods, fluorescence activated cell sorting (FACS) and magnetic activated cell sorting (MACS) achieve high resolution sorting of cellular subsets based on surface antigens. Magnetic isolation methods have become widely accepted for clinical use, owing to their efficient cell enrichment and/or reduction in closed, partially- or fully-automated, current good manufacturing practice (cGMP)-compliant instruments. The only clinically approved device is the CliniMACS Cell Isolation System, which employs a colloidal suspension of super-paramagnetic microbeads directly conjugated to a monoclonal anti-human antibody capable of binding to its corresponding antigen contained in bone
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