Cobetter SPTFF Technology Enables Continuous Liposome Manufacturing

Introduction

In the fast-evolving world of innovative drug development, liposome-based drugs shine like bright gems. Yet, traditional manufacturing methods have long faced 3 major challenges—high cost, low efficiency, and poor scalability—that slow down industrial progress.

How can this be solved? Cobetter’s SPTFF (Single-Pass Tangential Flow Filtration) technology and its related products bring innovation to the table, empowering continuous liposome manufacturing. With improved efficiency, stability, and scalability, this technology helps build a “fast track” toward high-quality production.

1. Current Challenges in Liposome Production

With the rapid growth of biotechnology and nanomedicine, liposomes have become a breakthrough drug delivery system, widely used in cancer therapy, vaccine development, and other fields. However, their complex structure presents multiple challenges for manufacturing:

Heavy dependence on batch production:

Batch-based systems have long production cycles, require large equipment footprints, and face batch-to-batch variability issues.

Bottleneck in downstream concentration and buffer exchange:

Conventional TFF systems (cassette- or hollow-fiber-based) are time-consuming, labor-intensive, and difficult to integrate seamlessly into continuous workflows.

High costs in large-scale manufacturing:

From lab-scale development to commercial production, pipeline design, equipment selection, and processing time all directly impact costs. Scaling up often leads to poor reproducibility and unstable product quality.

These challenges not only increase manufacturing costs but also slow down the pace of innovation development and commercialization for drug developers.

2. Limitations of Traditional TFF and the Demand for Continuous Manufacturing

In conventional liposome production, downstream concentration and diafiltration rely on tank-based tangential flow filtration (TFF). This “concentration-diafiltration-reconcentration” batch-mode process consumes large volumes of buffer and requires multiple holding tanks, along with frequent manual sampling. Which is a time-consuming, labor-intensive workflow that makes true continuous manufacturing nearly impossible.

Continuous manufacturing, as the future direction of modern pharmaceutical production, demands a process where materials are continuously fed in and products are continuously collected - with each processing unit operating like finely meshed gears in perfect synchronization. However, the nature of traditional TFF creates a major “disruption point” in this otherwise seamless chain, limiting process integration and overall production efficiency.

3. Cobetter SPTFF: Driving a New Breakthrough in Continuous Purification Technology

Building on its deep expertise in membrane separation, process design, and fluid dynamics, Cobetter has developed an innovative Single-Pass Tangential Flow Filtration (SPTFF) module that effectively addresses key challenges in continuous bioprocessing. This is not just an equipment upgrade—it represents a complete process evolution.

Advantages of Cobetter SPTFF

1. Simple yet highly efficient working principle:

With a single pass through one flow channel, SPTFF achieves over 5× continuous concentration and can be integrated with diafiltration, completing in-line buffer exchange in the same step.

Like a “concentration and exchange station” within the pipeline, the feed stream is processed as it flows through, directly producing material that meets the downstream requirements (such as sterile filtration or final filling).

2. True seamless continuity:

SPTFF modules can be directly integrated into continuous manufacturing lines, enabling 24/7 uninterrupted operation from upstream synthesis to downstream purification—eliminating production breaks entirely.

3. Remarkable system compactness:

No need for large feed or holding tanks. The system has minimal dead volume, saving both space and equipment cost, while greatly reducing product hold-up and loss. This is especially critical for high-value formulations such as liposomes, nanoparticles, monoclonal antibodies, and ADCs.

4. Superior product quality and consistency:

Continuous flow ensures excellent process robustness. SPTFF provides a stable shear force and consistent transmembrane pressure (TMP), maintaining liposome particle size and PDI during concentration and diafiltration without damaging the lipid bilayer structure—resulting in higher, more consistent product quality.

5. Significant cost reduction and efficiency improvement:

Production efficiency increases several-fold, with smaller facility footprint, reduced manual operation, and lower buffer consumption. Overall, this dramatically reduces cost of goods manufactured (COGM) and strengthens the manufacturer’s competitive edge.

Case Study

Cobetter conducted a comprehensive evaluation in a lipid-based drug continuous manufacturing project. The test results demonstrated full compliance with process requirements and product quality specifications. In addition to assessing process feasibility, the stability and reliability of SPTFF performance during continuous operation were also thoroughly examined.

In one lipid nanoparticle (LNP) project, the continuous process was designed for a 15× concentration followed by a 15×diafiltration. Using Cobetter’s 300 kDa PES cassette (UFELA0300010P) building the SPTFF module. The system was configured in a two-stage continuous mode (Stage 1: concentration; Stage 2: in-line diafiltration) and operated continuously for over 13 hours, achieving a feed load of up to 200 L/m². Throughout the operation, the system pressure, filtration flux, and concentration ratio remained highly stable.

Integrated Continuous Operation Test

Empowering the Future: Partnering with Cobetter to Build a New Benchmark for Continuous Pharmaceutical Manufacturing

Cobetter’s SPTFF technology not only solves a bottleneck in downstream processing, but also provides the key to achieving intelligent, continuous, and digitalized manufacturing across the entire liposome manufacturing industry.

For pharmaceutical and CDMO companies aiming to lead in innovative formulations, adopting this technology means:

• Accelerating new drug commercialization.
• Enhancing product quality consistency.
• Optimizing production costs.

As a leading Chinese company in advanced filtration and purification technology, Cobetter offers not only world-class membrane filtration products and hardwares, but also a comprehensive end-to-end solution, from process development and equipment integration to validation support,  empowering customers to overcome the critical challenges of industrial production.