Sartoflow® Expert SU: Versatile Single-Use TFF
Extension package for safe ADC synthesis
The Sartoflow® Expert SU is a flexible, fully automated single-use TFF system for process development up to pilot-scale manufacturing of mAbs, vaccines, viral vectors, pDNA, highly viscous products, and bioconjugates like ADCs. With its innovative design, it can be configured to combine up to three steps on one skid — mixing, 0.2 µm filtration, and ultrafiltration/diafiltration in a robust fully closed single-loop system ensuring operator safety and product integrity.
A single system streamlines three steps (mixing, filtration, UF/DF) and eliminates product transfer.
Versatile cGMP single-use TFF system provides seamless transition from 1-20 L scale.
The system has the flexibility to accommodate different sequences of process steps.
A gamma irradiated closed-loop system prevents leaks and eliminates cleaning and cleaning validation efforts.
Improves cost-efficiency by eliminating the need for oversized systems.
Explore the Sartoflow® Expert SU System
The Sartoflow® Expert SU is a modular single-use system offering numerous standard and optional features. The TFF base unit for UF and DF applications can be extended with additional modules and consumables.
Recirculation & Mixing
Double Jacketed Bag Holder & 20 L 3D Single-Use Mixing Bags
In addition to the recirculation tank, the system is configurable with a second bag holder for an additional mixing solution on the skid. The corresponding Flexsafe® single-use 3D mixing bags allow efficient mixing and temperature control in 1–20 L scale. An integrated sampling port and sensors allow continual quality monitoring. The conical shape of the bags and bag holder enable maximum drainage for highest yields. All materials in product contact are resistant to organic solvents.
TFF Cassettes
Broad Range of Self-contained Units
Sartocube® and Sartocon® Self-Contained Units are pre-sterilized disposable units for use in cGMP environments.
- Available in a variety of MWCOs and in polyethersulfone (PES) and Hydrosart® membrane types
- Pre-flushed, sterile, ready to use
- No need for CIP, water flush and validation
- High product yield and high sustained flux due to low protein-binding membrane
- Glue-free/reduced extractables
Available sizes (m²): 0.14, 0.28, 0.42, 1.4
Each available in MWCO (kDa): 10, 30, 100, 300
Single-Use Closed Loop
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, including single-use bags and self-contained TFF cassettes. A 5-piston single-use membrane recirculation pump with overpressure protection is part of the feed flow kit. All materials in product contact are resistant to organic solvents.
- Bioburden reduced
- Chemical compatibility
- Spill-free process and disassembly
- Reduced hands-on time
- No cleaning or validation efforts
Start With Your Ideal Configuration
Start With Your Ideal Configuration
The system’s base unit contains state-of-the-art technology for Ultrafiltration and Diafiltration process steps, featuring
- A filter holder for 0.14, 0.28, 0.42, 1.4 m² self-contained units
- A recirculation pump and vessel
- Two peristaltic pumps for product and buffer addition
- Pressure-, flow-, conductivity sensors
- Automated pneumatic pinch valves
- Automated membrane valves in the retentate (TMP control) and permeate line
- Two connections for external balances
Select additional single features to add to the system TFF Base Unit or choose the complete Extension Package – adding 2nd mixing on board (e.g., for bioconjugation) and other features to get the most out of 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 |
Temperature Control Unit (TCU) | Optional | Included |
Uninterrupted Power Supply (UPS) | Optional | Included |
External Display | Not Available | Optional |
ADC Application: Automated Toxin Transfer | Not Available | Included |
UV Detection | Optional | Optional |
ADC Applications
ADC Manufacturing, Streamlined
Currently, 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 providing safety for both the operator and product.
Application Note: 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.
Piramal Uses Sartoflow Expert SU for ADC Process: See the Results
Process timeline shortened by 70%. Easy single-use set up. High performance retained. Read their story and see their results using Sartoflow Expert SU.
Safety & Integrity
Comprehensive Risk Mitigation
Reduce risk with these features:
- Fully closed-loop with chemical compatibility of all materials in product contact
- Integrated overpressure protection in single-use pump head
- Pre-use integrity test of single-use bags
- Operational from outside an isolator or fume hood with detached touch panel and safety door switch
- Uninterrupted power supply: system runs additional 10 minutes in case of power failure to secure the process and data
- Optional UV detection in permeate as protein guard
Streamlined Process
Three Unit Operations in One Fully Automated Single-Use Solution
Sartoflow® Expert SU streamlines three unit operations on one skid
- Fully closed single-use loop limits bioburden
- Low holdup volume around 400 mL
- Eliminate transfer between unit operations and potential exposure to cytotoxic compounds, thus providing safety for both the operator and the product.
Agility
Accelerate Transition to Commercial
One system can facilitate the transition from process development, toxicology studies, and clinical trials to low-volume commercial production, saving time and enabling consistent and reproducible processes. In addition, the system enables the adaption of flexible process sequences for varied conjugation strategies.
Explore More
General Specification | |
|---|---|
Weight | ~450 kg |
| System dimensions (length × depth × height) | Base Unit: 1,430 x 755 x 1,755 mm (nominal) With 2nd bag holder: 1,875 x 755 x 1,755 mm (nominal) |
CGMP Available | Yes |
System Specification | |
Membrane Area | 0.14, 0.28, 0.42, 1.4 m² |
Vessel Volume | 20 L 3D mixing & temperature control |
Flow Rate / Pump Capacity - Recirculation | up to 900 L/h |
Flow Rate / Pump Capacity - Media Addition Pumps | Up to 1,500 mL / min |
Minimum Recirculation Volume | ~600 mL |
Process Mode (Multi-Use / Single-Use) | Single-use |
Max. Pressure | 4 bar | 58 psi |
Wettware Specification | |
Tube ID | 3/8" (9.6 mm) |
Connectivity | Sterile (aseptic) |
Sensors | Pressure (TMP, inlet, outlet, delta pressure) Flow (permeate, retentate, feed) Temperature (bags) pH (2nd mixing bag) Conductivity (recirculation bag) UV (permeate / optional) |
