Performance Of The DIANT sp2TFF System Across Different Flow Regimes

In the rapidly evolving landscape of bioprocessing, the ability to perform reliable buffer exchange and concentration steps is critical for ensuring product quality, process scalability, and operational efficiency. The DIANT sp2TFF (single-pass tangential flow filtration) system has been designed to address these challenges by offering a versatile, low-pressure solution for efficient downstream processing. Recent experimental runs comparing high- and low-flow conditions further validate the system’s robustness and flexibility in meeting diverse operational demands.

Understanding the Two-TFF Process

Tangential Flow Filtration (TFF) is a widely used method in biotechnology for separating and concentrating biomolecules. The DIANT sp2TFF system employs dual-stage TFF configuration, allowing for sequential buffer exchange and concentration in a streamlined manner. This two-step process helps reduce processing time and minimizes handling steps compared to conventional batch filtration approaches.

The key variables in these experiments included feed flow rates, inline dilution rates, and retentate flow rates across two conditions: a high-flow run, and a low-flow run. Performance was assessed based on system pressures, buffer exchange efficiency, and concentration capability.

High-Flow Run: Efficiency at Scale

During the high-flow operation, Feed 1 was maintained at 400 mL/min, with an inline dilution flow rate of 360 mL/min. Retentate 1 and Retentate 2 were set to 40 mL/min and 20 mL/min, respectively.

Under these conditions, the system successfully achieved a 10X buffer exchange followed by concentration to the desired level. Notably, throughout the process, system pressures for both TFF1 and TFF2 remained consistently below 10 PSI, highlighting the system’s ability to maintain stability even under demanding conditions.

The results underscore two important features of the DIANT sp2TFF system:

• Robustness under high throughput – The system demonstrated that it can reliably handle large flow rates without compromising process control or integrity.
• Operational efficiency – The ability to achieve significant buffer exchange and concentration under low-pressure conditions highlights the system’s design advantage, reducing stress on membranes and extending operational longevity.

In practical terms, this run validates the DIANT sp2TFF system as a strong candidate for large-scale bioprocessing applications, where throughput and efficiency are paramount.

Low-Flow Run: Reliable Performance Under Gentle Conditions

In contrast, the low-flow experiment evaluated the system’s capability under reduced operating conditions. Here, Feed 1 was set at 50 mL/min with an inline dilution rate of 40 mL/min, while both Retentate 1 and Retentate 2 were maintained at 10 mL/min.

Despite the significant reduction in flow rates, the DIANT sp2TFF system again delivered impressive results. The process achieved a 5X buffer exchange and a 5X concentration, with operating pressures maintained below 5 PSI across both TFF1 and TFF2.

The low-pressure stability demonstrated here emphasizes several benefits:

• Gentle handling of sensitive molecules – Lower pressures minimize shear stress, which can be especially advantageous for fragile biologics such as viral vectors, proteins, or nanoparticles.
• Consistent reliability – The ability to operate stably across different flow regimes speaks to the system’s flexibility and robustness.
• Energy and resource efficiency – Reduced flow rates lower energy demands and can help optimize small-scale or early-stage process development.

This flexibility makes the DIANT sp2TFF system a valuable tool not only for large-scale applications but also for pilot studies, laboratory-scale research, and processes where delicate handling of biomolecules is critical.

Key Takeaways

The comparative runs highlight the adaptability and strength of the DIANT sp2TFF platform:

• Versatility: Effective in both high-flow and low-flow conditions, achieving buffer exchange and concentration targets reliably.
• Low-pressure operation: Maintains pressures below 10 PSI (high flow) and below 5 PSI (low flow), supporting stable performance and reducing wear on membranes.
• Scalability: Demonstrates potential for application across a wide spectrum of use cases, from small-scale R&D to industrial-scale manufacturing.
• Robust performance: Ensures consistency and reliability across varied operating conditions, a vital feature for biomanufacturers seeking dependable process solutions.

Implications for Bioprocessing

In biopharmaceutical manufacturing, efficiency and flexibility are increasingly critical. Processes must not only deliver consistent results but also adapt to varying scales and product requirements. The DIANT sp2TFF system addresses these needs by combining scalability with gentle, low-pressure operation.

For companies developing biologics, gene therapies, or advanced nanoparticles, these features translate into practical benefits: higher product recovery, reduced processing times, and greater confidence in scale-up from laboratory to commercial production.

As biologics and advanced therapies continue to expand, technologies like DIANT sp2TFF that demonstrate both robustness at scale and gentleness at low flow rates will be vital in driving innovation forward.