Automated Single-Use TFF for Biopharmaceutical Processing
Flexible across a range of modalities
The Sartoflow® Expert SU is a flexible, fully automated single-use TFF system designed for use from process development through pilot-scale manufacturing. It supports a broad range of biopharmaceutical modalities, including mAbs, vaccines, viral vectors, pDNA, highly viscous products, and bioconjugates such as ADCs.
The system can be configured for up to three process steps on a single skid: mixing, 0.2 µm filtration, and ultrafiltration | diafiltration (UF | DF). All steps are performed within a robust, fully closed, single-loop system, supporting process integrity and consistent product quality.
A single system streamlines three process steps — mixing, filtration, and UF | DF — and eliminates intermediate product transfers to improve cost efficiency.
The gamma-irradiated, closed-loop system saves operator time during preparation, sanitization, cleaning, and breakdown.
The system can accommodate various process-step sequences using flat-sheet cassettes or hollow-fiber modules.
Explore the Sartoflow® Expert SU System
A modular system for flexible TFF processing
The Sartoflow® Expert SU is a modular single-use TFF system with a broad range of standard features, plus optional modules and consumables.
Double-jacketed bag holder & 20 L 3D single-use mixing bags
In addition to the recirculation tank, the system can be configured with a second bag holder for an additional mixing solution on the skid. The corresponding Flexsafe® single-use 3D mixing bags support efficient mixing and temperature control for volumes from 1 to 20 L. An integrated sampling port and sensors support continuous quality monitoring. The conical design of the bags and bag holder enables maximum drainage to maximize product recovery. All product-contact materials are resistant to organic solvents.
Broad range of self-contained units
Sartocube® and Sartocon® self-contained units are pre-sterilized, disposable cassettes designed for use in cGMP environments.
- Available with polyethersulfone (PES) or Hydrosart® membranes in a range of MWCOs
- Pre-flushed, sterile, and ready to use
- No need for CIP, water flushing, or associated validation
- Low protein-binding membranes support high product yields and sustained flux
- Glue-free design for reduced extractables
Available filtration areas: 0.14, 0.28, 0.42, and 1.4 m²
Each size is available in 10, 30, 100, and 300 kDa MWCOs
Fully single-use closed loop for bioburden-reduced processing
The single-use flow kits for Sartoflow® Expert SU are gamma-irradiated and can be connected in a fully closed loop with single-use bags and self-contained TFF cassettes. A five-piston single-use membrane recirculation pump with overpressure protection is included in the feed flow kit. All product-contact materials are resistant to organic solvents.
Reduced bioburden
Chemical compatibility
Spill-free process and disassembly
Reduced hands-on time
No cleaning or validation effort
Select your ideal configuration
Tailor the Sartoflow® Expert SU system to your process
The system’s base unit features state-of-the-art technology for UF | DF process steps, including:
- A filter holder for 0.14, 0.28, 0.42, and 1.4 m² self-contained units
- A recirculation pump and vessel
- Two peristaltic pumps for product and buffer addition
- Pressure, flow, and conductivity sensors
- Automated pneumatic pinch valves
- Automated membrane valves in the retentate line for TMP control and in the permeate line
- Two connections for external balances
- Uninterrupted power supply (UPS)
Select additional features to add to the TFF base unit, or choose the complete Extension Package, which includes a second onboard mixing position for applications such as bioconjugation, along with other options that expand the system’s capabilities.
TFF Base Unit | Extension Package | |
|---|---|---|
|
| |
| Additional mixing vessel | Not available | Included |
| Sterilizing-grade filtration | Optional | Included |
| Peristaltic media addition pumps (4x) | Optional | Included |
| TCU | Optional | Included |
| Uninterrupted power supply | Optional | Included |
| External display | Not available | Optional |
| Automated toxin transfer (ADC applications) | Not available | Included |
| UV detection | Optional | Optional |
| Hollow fiber filter holder and aseptic lines | Optional | Optional |
Applications for antibody-drug conjugates
Streamlined ADC manufacturing
Traditionally, antibody-drug conjugate (ADC) synthesis, precipitate removal, and subsequent TFF occur within separate unit operations. Time-consuming and risky transfer steps are necessary between process steps. The Sartoflow® Expert SU is the first fully automated single-use system to streamline these three steps on one system, simplifying ADC processing while enhancing safety for both the operator and product.
Performance of Sartoflow® Expert SU in ADC processes
Learn more about the capabilities of the Sartoflow® Expert SU for ADC processes, configurable to perform incubation, purification, and concentration of ADC synthesis.
Comprehensive risk mitigation
Reduce ADC processing risks with the following features:
Fully closed-loop design with chemically compatible product-contact materials
Integrated overpressure protection in the single-use pump head
Pre-use integrity testing of single-use bags
Operation from outside an isolator or fume hood using a detached touch panel and safety door switch
Uninterrupted power supply that keeps the system running for 10 minutes after a power failure to protect the process and data
Optional UV detection in the permeate as a protein guard
Three unit operations in one fully automated single-use solution
Sartoflow® Expert SU streamlines three unit operations on a single skid.
Fully closed, single-use loop reduces bioburden
Low hold-up volume of approximately 400 mL
Eliminates transfers between unit operations, reducing potential exposure to cytotoxic compounds and supporting operator and product safety
Accelerate the transition to commercial production
A single system can facilitate the transition from process development and toxicology studies through clinical trials to low-volume commercial production, saving time and enabling consistent, reproducible processes. The system also allows process sequences to be adapted for different conjugation strategies.
Learn More About Sartoflow® Expert
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Frequently asked questions
Yes, open cassettes can be integrated with the use of adapter plates.
Only the standard versions of the conjugation and recirculation bag are available. However, they offer a variety of connections for inlets, thorough mixing, as well as pH measurement (conjugation bag) or conductivity measurement (recirculation bag).
The system’s filter holder is designed to accommodate both Sartocon® Slice and standard Sartocon® formats, providing a high degree of flexibility without the need for an external holder. In addition, the system can be equipped with an external hollow fiber filter holder.
The Sartoflow® Expert SU is optimized for 20 L bags to ensure maximum performance and the highest level of process safety.
The mixing and recirculation bags can be integrity tested using, for example, an external Sartocheck® device.
