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ENABLING REGULATORY-COMPLIANT BIOMANUFACTURING OF PROTEINS, VIRAL VECTORS AND VACCINESThe MaxCyte VLX® is a small-footprint, easy-to-use system for extremely large volume cell-engineering. It uses Flow Electroporation™ Technology to provide unmatched performance and support large-scale production of proteins and viral vectors for R&D through cGMP pilots and commercial manufacturing.
HIGH-PERFORMANCETransfection efficiencies and cell viabilities >90% for commonly used cell types with high day-to-day and user-to-user consistency
FLEXIBLEEngineer a wide range of cell types using a single animal component-free electroporation buffer and a library of cell-specific protocols for plug-and-play transfection
SCALABLETransfects up to 2 x 1011 cells in <30 minutes with seamless scalability and requires no re-optimization
REGULATORY PATHWAYClosed, cGMP-compliant, ISO-certified and CE-marked system that uses sterile, single-use processing assemblies and is supported by an FDA Master File
PROGRAMS ENABLED BY THE MAXCYTE VLX:• AAV • Antibodies• Lentivirus • Recombinant proteins• VLP, VRP • Multi-plasmid constructs
ACCELERATING DEVELOPMENT & BIOMANUFACTURING
FASTER • Plasmid to protein in days to weeks• Rapid response to biological threats• Broad cell type flexibility• Consistency from run to run• Simple scalability of MaxCyte
STX® to MaxCyte VLX®
BETTER• High expression levels• Sustained productivity• Improved manufacturability • Higher yield
COST-EFFECTIVE• Reduced process volumes• Lower capital expenditures• Lower operating costs• Single use disposables
MaxCyte VLX® Large-Scale Transfection System
... rapid response, higher titers, higher yields, and lower process volumes.
250
5075
100125
175200
150
Run 1
FFU
/Cel
l
Run 2
145±16121±13
0.2
0
0.4
0.6
0.8
1.2
1.0
# cellsSTX4E7
Nor
mal
ized
Viru
s Ti
ter
STX1E9
VLX1.1E10
www.maxcyte.com | +1 301-944-1700 | [email protected]
MaxCyte, MaxCyte STX, and MaxCyte VLX are registered trademarks of MaxCyte, Inc. © 2017 MaxCyte, Inc. All Rights Reserved.
Vero cells grown in a 100 L stir-tank bioreactor were harvested from microcarriers, concentrated by TFF and centrifugation, and washed in PBS before resuspension in MaxCyte EP buffer. 1E11 cells were transfected using the MaxCyte VLX with RNAs encoding genes required for alphavirus replicon particle production. After electroporation, cells were cultured in a 100 L stir-tank reactor for VRP production. Yields reflect functional particles produced per cell (FFU = focus forming unit).
Data courtesy of
ONE TECHNOLOGY: FROM R&D TO BIOPRODUCTION
A. Lentivirus Production
MAXCYTE VLX CONSISTENCY AND RELIABILITY
Alphavirus VRP Production
B. Antibody Production
High Expression Levels Following MaxCyte Transfection Allow for Reduced Culture Volumes. This series of studies was conducted in nine different laboratories at various global locations over a two-year period to demonstrate the superior performance of the MaxCyte Delivery Platform. Side-by-side transfections were performed using standard, unoptimized MaxCyte transfection procedures versus client-optimized chemical transfection methods. Higher expression levels, ranging from 10–65 fold increases, for a variety of therapeutic types were observed following MaxCyte transfection compared with chemical methods.
Increased expression levels greatly reduces the culture volumes required for bioproduction. The far right column represents the volume of culture from the chemical transfections that would be required to produce the same amount of protein as that from a 50 L culture following a single MaxCyte VLX transfection.
Therapeutic TypeFold Increase
MaxCyte vs. Chemical Transfection Titers
Chemical Tnsfxn Culture Vol. Needed
to Equate to 50 L VLX Culture (L)
Fc fusion 12.5 2250Fusion protein 19.5 977Fusion protein 20.3 1017Monoclonal Ab 10.8 540Monoclonal Ab 20.0 1000Monoclonal Ab 50.0 2500Recombinant protein 27.3 1366Recombinant protein (in insect cells) 65.0 3250
Vaccine 30.0 1500Viral envelope protein 10.0 500Viral envelope protein 25.2 1261
EFFICIENT TRANSFECTION FOR SIMPLIFIED UPSTREAM & DOWNSTREAM PROCESSING
Seamless Scalability Using the MaxCyte Platform. A. HEK 293FT cells were resuspended in MaxCyte electroporation (EP) buffer at 1E8 cells/mL containing a mixture of plasmids encoding lentiviral vector components (0.4µg of DNA/1E6 cells). Cells were transfected using the MaxCyte STX or MaxCyte VLX, depending on the scale of the transfection. Lentiviral titers were measured after 24–48 hrs in culture. B. CHO-S cells were transfected using either the MaxCyte STX or MaxCyte VLX. Post transfection cells were resuspended at 4E6 cells/mL using the indicated volumes. Antibody titers were determined 14 days post transfection.
0.20
0.40.60.8
1.41.2
1.6
1.0
culture volumeSTX1L
Nor
mal
ized
Ab
Tite
r
STX1L
VLX15L
1.00 0.941.03
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