Sepragen
THE FUTURE OF BIOMANUFACTURING IS NOW
Over the past 20 years, Sepragen Corporation has been a world leader in state-of-the art downstream purification products, where they help manufacture over 20+ FDA approved drugs in over 200 global installations.
Radial Flow Columns
- From lab scale to cGMP Production
- Re-usable columns
- Single-use/pre-packed columns
- Pre-packed columns with resin of choice
In-Line Buffer Dilution/Buffer Making Systems
- Stand alone or integrated into Chromatography Systems
Inexpensive, fast Single-Use Resins
Chromatography Systems
- Single-Use Chromatography Systems
- Continuous Chromatography Systems
- Chromatography Systems with Buffer Dilution/Filtration
- Dual Chromatography System
- Standard Automated Chromatography Systems
- Custom Chromatography Systems
Radial Flow Chromatography Columns
From lab scale to cGMP production
Proven in over twenty clinically approved products
Key advantages over traditional axial columns:
- Faster Separations at lower cost
- Radial flow columns have a higher sample contact surface area than conventional axial columns
- For the same linear velocity, the volumetric flow-rate is thus much higher
- Since the desired volume can be achieved without going wider, the footprint is smaller
- Small bed heights can be achieved within an annular configuration
- Packing columns is easier and more manageable
- Linear scale-up enables faster time to market
From Lab Scale
To Production
Traditional Axial Columns
- Slow flow rates and large cycle times
- Greater resin usage for same productivity
- Bigger columns with a large footprint
- Performance compromise with scaling up
- Packing is cumbersome and requires investment in infrastructure
- High purification costs
Radial Flow Columns
- 4x higher flow rates
- Higher productivity
- Lower pressure drops: <1bar
- Smaller footprint
- Faster separations
- Less cost: Reduce Protein A cost by >50%
- Linear scale: Same pressure, same cycle time, same performance from 20ml to 400L column size
- Optional Single-Use/Pre-Packed Columns
Single-Use Chromatography Systems with disposable flow path:
- Two off-the-shelf sizes to choose from (10-300ml/minute AND 30-3000ml/minute)
- Very compact with minimal holdup volume
- Less expensive consumable cost then competitive products
- Disposable flow path includes all sensors for air, flow, pressure, conductivity, pH and UV
- Installation takes only 15-20 minutes
Dual Column Continuous Chromatography Platform with Integrated Buffer Blending/Making Capabilities
- Lab scale or pilot/production dual column, continuous capture, and flowthrough (IEX, HIC and Nanofiltration combined) systems with integrated buffer blending/making capabilities
- Buffers can be made from stock solutions and delivered automatically for each step
- Brings the power of continuous chromatography without the bottleneck of preparing large quantities of buffer needed for continuous chromatography.
- Two columns are running in an asynchronous mode i.e., when one column is loading, the other column is going through the non-load steps (wash, elution, regeneration, & equilibration), and vice versa
- Integrates with perfusion reactor so that a continuous feed is always maintained
- Helps to reduce FTE requirements, space constraints, resin costs, etc.
Dual Chromatography System – PD and Pilot chromatography system in one small footprint
- Our most requested Chromatography System
- Can replace two separate systems in one small benchtop unit
- Dual flow rate with two separate flow paths
- Low flow: 1 - 100 ml/minute and High flow: 1 – 1000 ml/minute
Standard Chromatography Systems - All chromatography systems are 21CFR Part 11 Compliant
- Suite of fully automated liquid chromatography systems from bench scale up to full scale production
- Greater flow rate range with 100:1 turn down ratio
- Real time air and leak detection
- Space efficient – requires up to 70% less space than competitive systems
- Easy programming, security/controlled access, cGMP reports, event logs for traceability, data analysis – compare real-time with pre-existing runs, calibration history/reports
Custom Chromatography Systems
- We can help you customize a solution to best meet your requirements
- With a combined over 100 years of Bioprocess experience and 16 patents, we specialize and welcome the opportunity to create a custom solution which best suites your needs.
- From concept through design, fabrication and installation
Custom projects include:
- Integrated chromatography skid with buffer making and pH adjust
- cGMP skid for Botox manufacturing up to 10 mls/minute
- Custom open skids up to 40 lpm
Increase Buffer Making Capacity without Increasing Tank Capacity
- Make concentrates in smaller tanks and dilute at point of use
- PAT capability eliminates buffer testing and release
- Flow rates 5 L/minute to 30 L/minute
- Small footprint: 30” x 27” x 42”
- 110V and 90 psi instrument quality air
- Total accuracy +/- 3% actual flow or 0.3% FS
- Composition accuracy +/- 5% or 0.5% FS
- pH control +/- 0.1pH
4X Higher Flow Rates than Competition
- Rigid Hydrophilic methacrylate microporous bead
- Significantly lower price than competitive resins
- 50% higher flow than “Fast Flow” media
- Operating pressure 500 psi
- Q and S functionality available
- Cleanable in 1M NaOH
- 1000 cycles
- Operating scale: 100 Liter column
- Productivity/$ = (capacity x flowrate)/$
QS Packer is the world’s first automated packing system for packing its innovative Superflo, Radial Flow Columns.
The Packing Skid Enables:
- Reduced reliance on “technique” and specific operator skill and ensures a standardized operation across a range of operators.
- Reproducibility in column performance by using the same criteria for packing while noting any deviations
- Column performance can be calculated after column packing and reassessed periodically after storage and before re-use
- It enables electronic documentation of packing batch record. Different packing methods for different size Columns or different resins can be stored and recalled on demand.
- Data can be stored and compared with pre-set pass/ fail criteria for validated use.
The system takes the user through the various steps of:
- Air removal
- Column priming
- Column packing
- Bed stabilization
- Column packing integrity check
Pneumatically driven diaphragm pumps and automated diaphragm slurry and buffer valves, column packing and running valve manifold, air removal device and sensors for measuring pressure, air, UV and conductivity.
Software
The software enables either operator driven manual packing via a user friendly GUI or method driven automated packing once clear procedures are developed. Various packing protocols which include different flow rates, packing pressures for different columns and different resins can be stored in the QS Packer’s 21 CFR Pt11 compliant software. A salt, acetone or trace protein may be used to check bed integrity. The system software calculates the Asymmetry and HETP. Column packing batch reports are created and may be stored for review, comparison and retrieval.
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