C O S T A N A LYS I S

COMPARING CELL THERAPY

MANUFACTURING QC COSTS
OF TRADITIONAL FLOW
CYTOMETRY VERSUS THE
ACCELLIX PLATFORM

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Here, we showcase a cost comparison between cell The Accellix Platform streamlines flow cytometric
therapy flow cytometry QC on the Accellix Automated analysis in GMP manufacturing by automating
Cell Phenotyping Platform versus a traditional flow sample preparation and data analysis; the most
cytometer. By automating a complex and laborious manual, variable, and laborious workflow steps.
process, and by bringing flow cytometry directly into The Accellix Instrument can be operated directly
the GMP manufacturing suite, the Accellix Platform in the GMP manufacturing suite, eliminating the
reduces the costs of labor, reagents, QC lab space need for a centralized flow cytometry QC lab and
and instrument by 50-300% (Figure 4), enabling cell requiring only one hour of training. Less-skilled and
therapy manufacturers to scale QC to a growing lower-paid technicians can operate the platform
patient population. with fewer operating costs to purchase and maintain.
Here we highlight a cost analysis comparing a
Flow cytometry, an indispensable tool in many areas typical flow cytometry QC workflow to the Accellix
of biology, serves as the gold standard for cell analysis workflow, revealing the cost savings associated
in cell therapy manufacturing. Using a single platform, with adopting the Accellix Platform in clinical scale
cell therapy manufacturers can measure a variety of cell therapy manufacturing.
parameters, including cell viability, potency, genetic
engineering efficiency, and phenotype. Despite its
utility in cell therapy research and development,
traditional flow cytometry is not easily transferable
into the GMP manufacturing environment due to the
complexity and variability associated with individual
operator handling, reagents, instrument setup and
maintenance, sample preparation, data acquisition,
and analysis. This complexity is also associated with a
high cost, which is largely driven by the need for highly
trained personnel to execute many manual steps. In
addition, flow cytometers tend to be very expensive to
purchase, costly to maintain, and require a centralized
flow cytometry Quality Control (QC) lab space to
operate in.

As more cell therapies are approved and become

first-line therapies for some indications, the increased
patient load will make it nearly impossible to
manufacture and QC sufficient samples using the
processes in operation today. Increased cell therapy
manufacturing will require recruiting, training, and
retaining a larger number of highly skilled and well
compensated flow cytometry technicians (Ham et al).
Considering that a talent gap already exists in the cell
therapy manufacturing space, there aren’t enough
qualified personnel to execute QC workflows, and
the associated costs will remain prohibitively high for
patients and insurers (Piller, M).

1.
CONSIDERATIONS Starting Post- Post- Expansion Formulation/
Material Selection Modification Release
Phenotyping Steps: For this analysis, we used a
Traditional 1TBMNK 1TBMNK 1TBMNK 1TBMNK 1TBMNK
representative CAR-T cell manufacturing workflow Flow panel w/o
Cytometer CAR
panel w/o
CAR
panel
w/ CAR
panel
w/ CAR
panel
w/ CAR
with five phenotyping steps during the process Accellix 1T Cell Assay 1T Cell 1CAR Assay 1CAR Assay 1Lymphocyte
1Lymphocyte Assay
(Figure 1). At several phenotyping steps, a single
Assay
Assay 1CAR Assay

antibody panel is employed on the traditional FIGURE 1. PHENOTYPING STEPS DURING REPRESENTATIVE
CAR-T CELL MANUFACTURING PROCESS.
cytometer, while the panels are separated into two
kits on the Accellix Platform (Figure 2). In practice,
TRADITIONAL AC C E L L I X
all of the cell surface markers may not need to be F LOW C Y TO M E T E R

analyzed in every workflow. For ease in calculating TBMNK

T CELL SUBSET
ASSAY
LYMPHOCYTE
SUBSET ASSAY
CAR CUSTOM ASSAY
(REPRESENTATIVE)
costs, we assumed that all five phenotypic analysis
CD45 CD45 CD45 CD45
per patient would occur on a single day, though, in
CD3 CD3 CD3 CD3
reality, they can be spread across several weeks.
CD4 CD4 CD14 CD4

1. Starting Material: The starting material (e.g., CD8 CD8 CD19 CD8

apheresis) is analyzed to determine the viability and CD14 Viability CD16 anti-CAR

frequency of CD4+ and CD8+ T cell populations, as CD19 CD56 Viability

well as non-T cells like CD19+ B cells and CD56 Viability
CD14+ monocytes.
Viability
2. Post-selection: We assume that purified T cells anti-CAR
are the desired input material for this workflow. (as needed)

Therefore, we include a phenotyping step after cell
selection (e.g., via ficoll separation or magnetic
beads) to assess the purity of the post-selection cells.
3. Post-modification: Several days after cells are
genetically modified (e.g., via lentiviral transduction),
we assume that cells are analyzed to assess the
efficiency of modification using an antibody panel
containing an anti-CAR antibody.
4. Expansion: During the expansion phase, we
assume that cells are analyzed to ensure the cell
modification remains stable and that the relative
proportion of T cell subsets is maintained.
5. Formulation/Release: Prior to final cell product
formulation and release to patients, we assume
that cells need to be analyzed to determine viability,
proportions of CAR+ T cell subsets, and the presence
of contaminating cell populations.
FIGURE 2. ANTIBODY PANELS USED ON A
TRADITIONAL FLOW CYTOMETER VERSUS THE
ACCELLIX PLATFORM.
Labor Costs: Traditional flow cytometry requires
highly trained, specialized staff who must be
compensated accordingly. Thus, we estimated a
$75/hour salary for these employees. In contrast,
the Accellix Platform can be operated by anyone
within one hour of training, as most of the workflow
is automated and does not require skilled manual
labor (Figure 3). Furthermore, Accellix’s algorithm-
based automated data analysis also eliminates
the need for these operators to perform complex,
time-consuming, and subjective data analysis.
Therefore, we estimated a $40/hour salary for
these employees.

2.
 COST ANALYSIS
TRADITIONAL
ACCELLIX
FLOW CYTOMETRY
WORKFLOW
WORKFLOW
(MINUTES)
(MINUTES)

Thaw + Prepare Cells 60 21

TRADITIONAL FLOW ACCELLIX
Assay Execution 90 26 CYTOMETRY WORKFLOW WORKFLOW

Instrument Setup 15 0 Labor Cost per patient* $356 $31

Data Acquisition 30 0 Staining Reagents per patient $451-$2200 $850

QC Flow Cytometry Space
Data Analysis 90 0 $542 $0
per day
Total FTE Hands-On Time 285 47 Instrument Cost per day $435 $98
FIGURE 3. HANDS-ON LABOR BREAKDOWN TO
ANALYZE SAMPLES FROM ONE PATIENT ON Total Cost $1784-$3533 $979
TRADITIONAL FLOW CYTOMETER VERSUS ACCELLIX FIGURE 4. COST BREAKDOWN TO ANALYZE SAMPLES
PLATFORM. FROM ONE PATIENT ON A TRADITIONAL FLOW
Reagents: Each Accellix Assay contains dried, unitized CYTOMETER VERSUS THE ACCELLIX PLATFORM.
and room temperature stable reagents that are ready *Labor cost only considers hourly wages and does not
account for additional costs associated with a fully
for use immediately. In contrast, antibody labeling burdened employee.
for traditional flow cytometry experiments typically
Based on the assumptions described earlier, we
requires aliquoting small volumes of multiple
calculated the cost required to phenotype five
reagents to generate an antibody cocktail and
samples per patient in a GMP clinical manufacturing
dependence on a cold chain. The remaining reagent
setting utilizing a traditional flow cytometer in
leftover in the antibody tubes may be used
a centralized flow cytometry QC lab versus the
in subsequent experiments, though some cell
Accellix Platform within the manufacturing suite.
therapy manufacturers opt to use the entirety of
Due to the highly manual nature of the traditional
each antibody tube for processing a single patient.
flow cytometry workflow and the qualifications
Thus, we include a range of reagent costs
required from this employee, we estimated $356
depending on whether the fluorescent
in labor costs in this process, versus only $31 in the
antibodies are sub-aliquoted or not.
automated Accellix workflow.
QC Flow Cytometry Space: Because of its small,
We calculated the cost in staining reagents required
fan-less design, the Accellix Instrument may be
to process five samples in triplicate for traditional
operated directly in the GMP manufacturing suite,
flow cytometry assuming that either antibodies are
obviating the need for a centralized, flow cytometry
sub-aliquoted and stock vials are used for multiple
QC space. Therefore, we removed the cost for this
patients, or a single tube of antibody is consumed per
space in the Accellix cost calculation.
patient. This yielded a range of $451–$2200
per patient in staining reagents for the traditional
Instrument Costs: We assume that a facility will
flow cytometry workflow, versus $850 in the
require at least two flow cytometers—one to
cartridge-based Accellix workflow.
operate and one for backup, though we included
three Accellix Instruments to increase throughput.
We estimated that a traditional cytometer with a
service contract costs $365,000, while an Accellix
Instrument with a service contract costs $82,000
and amortized this cost over seven years.

3.
 We estimated that a 2,000 square foot centralized
flow cytometry QC lab is required to process patient
samples on a traditional flow cytometer and
determined that this space costs $542 per day.
Given that the Accellix Instrument can operate within
a clean room manufacturing suite, we assigned $0
to this cost in the Accellix workflow. In comparing the
instrument cost, we estimated that purchasing and
maintaining two traditional cytometers costs $435
per day, while purchasing and maintaining three
Accellix Instruments costs $146 per day.
In total, we estimate that it costs between $1784 and
$3533 to phenotype five samples for one patient on a
traditional flow cytometer. In contrast, the automation
and simplicity of the Accellix workflow decreases
the cost by at least 50% to $979, potentially even
decreasing the cost by more than three-fold
depending on the reagent costs.
As cell therapies become accessible to more patients,
manufacturers will process greater numbers of
samples in parallel. To evaluate the costs of scaling
manufacturing to greater numbers of patients, we
calculated the cost to perform flow cytometry on
1, 5,10, and 40 patients, continuing to assume
five phenotyping samples per patient (Figure 5). In
this calculation, we used the higher reagent cost
associated with clinical manufacturing and assumed
that two traditional cytometers and four Accellix
Instruments will be employed to meet the higher
throughput needs. As expected, costs increased with
increased patient numbers for both platforms, but
interestingly, costs increased less dramatically when
the Accellix Platform is used. By calculating a slope
for each dataset, we found that the costs increased at
a rate of $3607 per patient using the traditional flow
cytometer, while they increased at a rate of $1092 per
patient using Accellix .

$160,000
$160,000
$160,000
$160,000 $141,301 $141,301
$141,301 Flow
Traditional Traditional
Traditional Flow
Flow
$160,000 $141,301
Traditional
Cytometer Flow
$160,000
$120,000
$160,000
$160,000 $160,000
$141,301
Traditional
$141,301 Flow
Cytometer Cytometer
Cytometer
Traditional Flow
$120,000
$120,000
$160,000
$160,000
$160,000
$160,000
$160,000 $141,301 $141,301
$141,301
$120,000 Traditional
Cytometer
Accellix Flow
Platform
Traditional
Traditional
Cytometer
Cytometer
Flow
Flow
$120,000 $141,301
$141,301
$141,301
$141,301
$141,301 Cytometer
$120,000 $120,000 $120,000 Traditional
Cytometer
Traditional Flow
Traditional
Traditional
Accellix Platform Flow
Traditional
Flow Flow Flow
Accellix
Accellix
AccellixPlatform
Platform
Platform
Platform
Cost

Accellix
$120,000
$80,000 Cytometer
Cytometer
Cytometer Cytometer
Cytometer
Accellix Platform
Accellix Platform
Cost

Cost

$80,000 $80,000
Cost

$120,000
$120,000
$120,000
$80,000 $120,000
$120,000
Cost

$80,000
Accellix Platform
Cost
Cost
Cost

$80,000
$80,000
$80,000 $43,050 $26,537
Accellix
$43,050
$43,050
Platform
$26,537 Accellix
AccellixPlatform
Accellix
Platform
Accellix
PlatformPlatform
$40,000 $40,000 $43,050
Cost

$80,000
$40,000 $40,000
$43,050 $26,537 $9,005
$13,757
$26,537 $13,757
Cost

$3,533 $9,005
Cost

Cost

Cost

Cost

$1,076
$13,757 $4,600
$80,000
$80,000
$40,000$80,000
$80,000
$80,000 $3,533
$0 $1,076 $4,600
$43,050 $9,005
$13,757 $26,537$0 $3,533 5$4,600
$43,050
$43,050
1
$1,076 40 10
$0$9,005 1
$40,000 $3,533
5
$43,050 40 10
Number of Patients
$1,076$13,757 $4,600$26,537 1 5 40
Number of Patients10
$40,000
$40,000
$40,000
$0 $3,533
$9,005 Number of Patients
$43,050
$43,050$43,050 $43,050
$43,050
1
$1,076$13,757
5
$4,600$26,537
10 $9,005 $26,537
$26,537 40
$40,000
$40,000
$0$40,000
$40,000
$3,533$40,000
$1,076$13,757 $4,600$26,537
$26,537$26,537
$26,537
$26,537
$0 1 5 $13,757
$13,757
Number 10 $9,005
of Patients 40
$3,533
$1,076$13,757
$13,757 $4,600
$13,757
$13,757
$13,757 $9,005
$9,005
$0 $3,533
$3,533
1 Number
5 of Patients $9,005
$9,005
10$4,600
$4,600 $9,005$9,005
40 $9,005
$3,533
$3,533
$3,533 $1,076
$1,076
$1,076$1,076
$3,533$3,533
$1,076 $4,600
$1,076$4,600
$1,076 $4,600$4,600$4,600
$0$0$0
$0 $0 1$0 $0 Number
5 of Patients
10 40
111 11 1 Number
5 15 5of
5 5 Patients
5 10 10
5 10 4010
10 10
10 40 40 40 40 40 40
Number
Numberof of
Patients
Number Number
Patients
of Number
Patients
of Patients
of Patients
Number
Number
of Patients
of Patients

FIGURE 5. COST TO SCALE QC FLOW CYTOMETRY IN A GMP ENVIRONMENT. Bar graph

shows cost to perform flow cytometry on samples from 1, 5, 10, and 40 patients on a
traditional flow cytometer (gray) and the Accellix Platform (red). Dotted lines represent
linear regression trendlines associated with each dataset.

4.
CONCLUSION
Reducing the cost to manufacture cell therapies is
critically important for broadening the accessibility of
these potentially curative therapies to larger patient
populations. QC of the cell products represents a
significant cost driver and traditional flow cytometry is
not scalable in its current form. The Accellix Platform
reduces these costs by simplifying and automating
the most manual steps in the flow cytometry process.
By bringing flow cytometric analysis directly into the
manufacturing suite where it can be performed by
minimally trained operators, the platform increases
reproducibility, lowers error rates, and reduces costs
by up to three-fold per patient, enabling cell therapy
developers to scale their manufacturing to meet the
demands of the future.

REFERENCES

Ten Ham RMT, et al. What does cell therapy manufacturing cost? A framework and methodology to facilitate
academic and other small-scale cell therapy manufacturing costings. Cytotherapy. 2020 Jul;22(7):388-397. doi:
10.1016/j.jcyt.2020.03.432. Epub 2020 May 12. PMID: 32414635.

Matthew Pillar. https://www.bioprocessonline.com/doc/taking-on-the-talent-crunch-in-biopharma-cell-gene-

manufacturing-0001

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Accellix Cost Analysis v.01, January 2022