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Transcript of Semba ProPDTM & ProGMP™ Systems - sembabio.comsembabio.com/wp-content/uploads/2017/07/Semba... ·...
ChemistriesA�nity
Hydrophobic interaction
Ion exchange
Mixed mode
Size exclusion
TargetsmAbs
Recombinant proteins
Vaccines
Viral vectors
Semba ProPDTM & ProGMP™ SystemsThe most productive continuous chromatography
platform for bioprocessing
To purify mAbs & other proteins
platform for bioprocessing
Semba Biosciences pioneered the development of easy-to-use bench top
SMB chromatography systems speci�cally designed for protein applications.
The new Semba ProPD™ and ProGMP™ Systems provide the economic and
operational bene�ts of multicolumn continuous chromatography for
bioprocess development and manufacturing. These mobile skid systems
enable straightforward conversion from batch to continuous processes and seamless scale-up to manufacturing while reducing chromatographic media
costs by up to 90%. The ability to run methods having 2 to 8 columns assures
maximum productivity at low or high titers. The unique capabilities of the
Semba ProPD & ProGMP Systems set them apart from other multicolumn
systems for process development and single-use manufacturing.
Superior performance• Proprietary valve block design provides equalized �ow paths for consistent column-to-column results and less dilution
• 2X greater operating pressure allows higher �ow velocities, faster run
times, wider range of applications
Easier process transfer• Identical cGMP-validated control system in ProPD and ProGMP units
• Flow rate autoscaling based on column dimensions
Greater scale-up e�ciency with ProGMP• Smaller footprint, mobile skid
• Less expensive hardware and consumables
• More e�cient resin utilization; more cycles per run
• Ideal for processing 50–2,000 L in 2–20 hours
Versatile bioprocess developmentThe Semba ProPD System is capable of performing almost any multicolumn
continuous chromatography protocol and uses up to 8 columns to provide
maximum productivity for the puri�cation of biomolecules at various feed
stream concentrations. Capture and polishing steps can be performed using
bind-elute, �owthrough and even isocratic methods with column or membrane
formats. Methods are created in the intuitive ProComposer™ application on any
Windows 7 (or later) computer and transferred via USB or internal network to
the ProPD System for execution.
The system features a proprietary pneumatic valve array based on the same
proven design used in Semba’s Octave™ System, and a GAMP5-compliant
control system identical to that found in the Semba ProGMP™ System for
single-use manufacturing. Up to six independent pumps control �uid �ow.
Up to four each of the onboard optical, conductivity, and pH sensors can be
connected to any of six outlets. The system can be readily con�gured to handle
various column sizes, �ow rates and feed volumes.
Speci�cations: Semba ProPD™ SystemDimensions (W / D / H) 51 / 39 / 73 in (130 / 100 / 185 cm)
Weight 506 lb/230 kg
Power requirements 100–120/220–240 VAC
Gas inlet supply 330–350 psi (23–24 bar); recommend 99.99% N2
Valve pressure At least 15 psi (1 bar) above �uid pressure
Maximum �uid pressure 270 psi (18.6 bar)
Pumps Six, stepper motor direct drive dual piston; PEEK™ �uid path; self-�ush pistons; accuracy +/– 3%;available �ow rate ranges 0–36, 0–100, 0–300 ml/min
Valve block 104 pneumatic two-way valves; Ultem® �uid path
Flow rate range 1 mm valve block: Up to 70 ml/min1.5 mm valve block: Up to 100 ml/min2.4 mm valve block: Up to 300 ml/min
Inlets Maximum 6
Outlets Maximum 6
Columns Maximum 8
UV-VIS sensors Four, each with wavelength range 195–820 nm;up to 2 wavelengths measured simultaneously
Conductivity sensors Four, range 0–200 mS/cm
pH sensors Four, range 0–14
Ordering Information Maximum Typical Vol Feed
Con�guration Cat. No. Flow Rate Column Size Per 8 h
Semba ProPD Base System H4001K
ProPD 1 mm Flow Kit H4020K 70 ml/min 1–40 ml Up to 20 L
ProPD 1.5 mm Flow Kit H4021K 100 ml/min 5–100 ml Up to 48 L
ProPD 2.4 mm Flow Kit H4022K 300 ml/min 15–300 ml Up to 144 L
SembaFlow™ 36 Pump H4010K 36 ml/min
SembaFlow 100 Pump H4011K 100 ml/min
SembaFlow 300 Pump H4012K 300 ml/min
The Semba ProPD Base System includes all hardware and software except pumps, valve block, and tubing. To con�gure a complete system users may specify one or more Flow Kits, which includethe valve block with corresponding channel diameter and matched tubing assemblies, and anycombination of SembaFlow Pumps. Please inquire for custom con�gurations.
Please inquire about Semba’s Octave™ range if you are looking for a bench top system and do notrequire GMP-validated control hardware and software.
ContactUSA [email protected] +1 866 634 1114
United Kingdom & Republic of Ireland [email protected] +44(0) 7900 300 567
Germany, Austria & Switzerland [email protected] +49 89 66055696
Taiwan & China [email protected] +886-2-85228321 Ext 10
Rest of World [email protected] +1 866 634 1114
mAb Feed g/L g/cycle Recovery Productivity 1 7.0 2.3/43 min 92.5% 80 g/L/h 2 7.9 2.4/41 min 90.1% 88 g/L/h 3 10.8 2.4/32 min 90.5% 112 g/L/h
Protein A capture results The diagrams show the ProComposer application’s Process Flow and Process Ribbon views of an 8-column method used for Protein A capture of 3 di�erent human mAbs.Culture �uids at the indicated concentrations were processed on the Semba ProPDSystem with 5-ml columns. Inclusion of 3 columns in the capture zone enabled residence times of 0.5 min/column, resulting in high recovery and productivity.
Copyright © 2017Semba Biosciences, Inc.Madison, Wisconsin USAwww.sembabio.com
The Octave™ Chromatography System is designed for highly productive
puri�cation of chemical and biological compounds. This bench top
8-column system is capable of simulated moving bed chromatography
(SMBC) and other continuous multicolumn protocols that increase
productivity up to 20-fold vs. conventional batch methods. Rather than
�owing �uids sequentially through one static column bed and collecting
fractions as in batch chromatography, SMBC uses a series of interconnected
smaller columns and “moves” the beds in the opposite direction of the �uid
to achieve countercurrent �ow, which greatly facilitates mass transfer and
resolution. Simulated movement of the beds is achieved via multiport valves
that enable periodic switching of the input and output �uids between
adjacent columns in the direction of �uid �ow. All �uid streams are
simultaneously applied and withdrawn at appropriate points between the
columns. When running at a steady state the various stages of separation
are performed simultaneously in di�erent columns in a continuous cycle.
The Octave System overcomes many of the previous limitations of
continuous chromatography, including size and complexity of equipment
and tedious method development. Proprietary valve blocks and control
software automate multicolumn protocols. Intuitive software tools facilitate
conversion of single column data to SMBC parameters. With its small footprint
and modular design, the Octave System brings the high resolution and
e�ciency of SMBC to the bench top, packing more puri�cation capability
into this space than any other similar-size instrument.
• Higher recovery and purity
• Up to 20-fold greater productivity than batch systems
• Up to 90% cost reduction in adsorbents and solvents/bu�ers
• Easy-to-use method development tools and control software
• Robust design with proven performance for many separation chemistries
• Easily customized for speci�c applications
• Available in 3 sizes to obtain grams to kilograms of product per day
ChemistriesA�nity
Chiral
Hydrophobic interaction
Ion exchange
Ion exclusion
Mixed mode
Normal phase
Reversed phase
Size exclusion
TargetsAPIs
Amino acids
Antibiotics
Enantiomers
Fatty acids
Natural products
Oils
Oligosaccharides
Organic acids
Proteins
Sugars
Sugar alcohols
OctaveTM Chromatography SystemContinuous (SMB) chromatography made simple
The power of SMBC on your benchThe power of SMBC on your benchhe power of SMBC on your bench
Modes of operation: Isocratic and StepIsocratic mode is the “classical” SMBC method that utilizes true countercurrent
separation. It is characterized by continuous �ow of a single solvent between
usually 3 or 4 separation zones de�ned by Feed and Desorbent inlets and
Extract (slow moving component) and Ra�nate (fast moving component)
outlets. Isocratic mode is widely used for separating closely related small
molecules such as sugar isomers, enantiomers, and fatty acids.
Step mode is characterized by operation of four or more distinct zones having
di�erent solvent conditions in a bind-elute strategy. Step mode can be used
when the separation factor is large; for example, in a�nity puri�cation of
recombinant proteins and antibodies or fractionating crude preparations by
sequential step elution. A�nity capture e�cency is dramatically enhanced by
having 2 or more columns in the capture zone and loading the �rst column to
near static capacity at high �ow rates; unbound target molecules are captured
by the downstream columns.
Isocratic ModeSeparation of vitamin B12 (1,355 Da; red) and Blue Dextran (2 x 106 Da; blue) by size exclusion on Sephadex® G-25 using eight 5-ml columns in a 3-zone isocratic con�guration on the Octave™ 10 System.
Step ModeProductivities obtained with �ve di�erent Protein A capture resins on the Octave™ 10 System. The 5-step process shown above was used with eight 1-ml columns to purify a human IgG1 mAb from culture �uid at 5 and 7.5 g/L concentrations.
Speci�cations: Octave™ System Dimensions (W / D / H) 21.5 / 21 / 19.5 in (55 / 53 / 50 cm)
Weight 100 lb/45 kg (without pumps)
Power requirements 100–120/220–240 VAC; 2/1 A
Gas inlet supply 330–350 psi (23–24 bar); recommend 99.99% N2
Valve pressure At least 15 psi (1 bar) above �uid pressure
Maximum �uid pressure 270 psi (18.6 bar)
Pumps Four in standard con�guration with maximum of 8; stepper motor dual piston; PEEK™ or stainless steel �ow path; self-�ush pistons; accuracy +/– 3%
Flow rate range 0–12, 0–100, 0–300 ml/min (depending on system)
Valve block 72 pneumatic two-way valves; Ultem® or PCTFE �ow path
Inlets 4 ; each can be shared by 2 pumps
Outlets Maximum 4
Columns Maximum 8
UV-VIS detector Octave™ 4XE UV-VIS Detector available separately; wavelength range 190–840 nm with up to 4 wavelengths measured simultaneously
Ordering Information Maximum Typical OutputCon�guration Cat. No. Pump Speed Column Size Per Day
Octave 10 System H1001K 12 ml/min 1–10 ml 1–30 gOctave 10-HS System H1020K
Octave 100 System H1002K 100 ml/min 10–100 ml Up to 300 gOctave 100-HS System H1014K
Octave 300 II System H1036K 300 ml/min 50–1,000 ml Up to 1 kgOctave 300 II-HS System H1081K
Octave 4XE UV-VIS Detector H1034K
HS systems include PCTFE (rather than Ultem) valve blocks for use with most organic solvents. Users may specify Octave 12-S, 100-S, or 300-S pumps containing stainless steel rather than PEEK (non-metal) �ow paths. Please inquire for custom con�gurations.
Please inquire about Semba’s ProPD™ and ProGMP™ Systems for bioprocess development and single-use manufacturing.
ContactUSA [email protected] +1 866 634 1114
United Kingdom & Republic of Ireland [email protected] +44(0) 7900 300 567
Germany, Austria & Switzerland [email protected] +49 89 66055696
Taiwan & China [email protected] +886-2-85228321 Ext 10
Rest of World [email protected] +1 866 634 1114
Copyright © 2017Semba Biosciences, Inc.Madison, Wisconsin USAwww.sembabio.com