The document describes the Bone Marrow Processing (BMP) protocol for Terumo BCT's Spectra Optia apheresis system. The protocol uses a single-bag approach to simplify the BMP procedure. Operators can monitor and control the bone marrow processing through the system's intuitive graphical user interface. The protocol reduces processing time to under 90 minutes while consistently concentrating the mononuclear cells and reducing red blood cells by over 97% and volume by over 80%.

1. BONE MARROW PROCESSING
(BMP) PROTOCOL
SPECTRA OPTIA® APHERESIS SYSTEM
1 Presentation title, Month #, Year. Confidential

2. Bone Marrow Processing (BMP) Protocol
Introduction
About Terumo BCT, Protocol Overview, How it Works, Accessory Set
Protocol Value
Features and Benefits
Comparison
Protocol Compared Between Systems
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3. 3
ABOUT TERUMO BCT
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4. Terumo BCT, a global leader in
blood component, therapeutic apheresis
and cellular technologies.
We believe in the potential of blood to do
even more for patients than it does today.
This belief unites our organization, inspires
our innovation and strengthens our
collaboration with customers.
Terumo BCT
Unlocking the Potential of Blood
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5. Looking at Terumo BCT at a Glance
Parent company: Terumo Corporation
Division: Blood Management Business
Chairman: David Perez
Revenues: Approaching $1B
President and CEO: David Perez
Associates: More than 2,700 globally
Classification: Medical Device Manufacturer
Industry: Blood Banking, Transfusion Medicine,
Cellular Therapies and Cell Processing
Customer segments: Blood Centers, Therapeutic Apheresis Centers
and Cell Processing
Global headquarters: Lakewood, Colorado, United States
Regional headquarters: Brussels, Buenos Aires, Hong Kong, Tokyo
Major manufacturing facilities: United States, China, India, Japan, Northern Ireland
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PROTOCOL OVERVIEW
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7. Protocol Overview
Bringing ease of use to BMP procedures
 The Spectra Optia system simplifies BMP procedures with:
 Helpful on-screen guidance
 Single-bag approach
 Minimal operator interaction needed throughout the procedure
 Allows operators to perform other tasks
 Processes bone marrow in under 90 minutes
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8. How it Works
Setting up the procedure
 Bone marrow is transferred into
the BMP accessory set, either by:
 Using a spike on the administration
line (includes 200 micron filter)
 Using the luer connector assembly
 The system is primed
 The system guides operators through
connecting the single BMP bag
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9. How it Works
Entering procedure data
 The system guides the operation
through setting various operating
parameters:
 Amount of bone marrow processed
 Number of processing cycles
 Target plasma volume
 With the parameters set, the system
processes bone marrow to:
 Collect mononuclear cells
 De-bulk and reduce the volume
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10. How it Works
Monitoring and adjusting the run
 The system provides operators with
information to monitor the progress of
the run
 Operators can adjust the collection
preference to control the
concentration of cells through the
collect port
Continuously compares how the
system is collecting cells with the
target collection preference Gives the ability to adjust
collection preference
Displays an image of the collect
port throughout procedure
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11. Accessory Set
BMP bag
Accessory Set Streamlines operator
used with the interaction with a single-bag
approach
IDL Set
Sample bulb assembly
Allows sampling before or
during the procedure while
maintaining a functionally
closed system
Administration line
Includes a 200-micron
filter on the line with
spikes for additional
filtration if desired
Compact packaging Minimizes the space required for storage
Color-coded components Simplify setup and operation
Functionally closed set Helps prevent contamination
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12. Protocol Value
Streamlines
operator
interaction
with a single-
bag approach
Provides Guides
operators with operators
control over through the
parameters to protocol with
meet target
processing
Advanced an intuitive
graphical user
outcomes technology interface (GUI)
and
operator
choice
Allows
operators to
perform other
Minimizes
tasks as the
memorization
system
and simplifies
continuously
training
monitors and
adjusts the
interface
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13. Protocol Value
Procedure precision and safety
Produces consistent results through interface stability
Performs red cell reduction greater than 97 percent*
Provides volume reduction greater than 80 percent*
Produces a final product volume under 200 mL*
Helps prevent the contamination of harvested bone marrow
with a functionally closed procedure
Frees up space, because a clean room is not required
*Data on file.
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COMPARISON

15. Comparison
Spectra Optia System COBE® Spectra Apheresis System
Single-bag approach with a constant Two product bags, operators required
flow, no clamping to move clamps during procedure
Automated Interface Management Operator manages interface
(AIM) system
Intuitive GUI with touch screen LED and touch pad
Plasma collection is optional and can Plasma is automatically collected
be configured depending on the other for most procedures
collection parameters
Collect valve opens automatically when Operator manually opens collect valve
cells are detected by AIM
Data management (reports), No data or report capabilities
stores up to 100 procedures
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