As advanced modalities like mRNA and viral vectors reshape the biomanufacturing landscape, Cytiva is scaling innovation to meet evolving demands. In this edition of Biopharma Boardroom Questions, Ludovic Brellier, President of Hardware Solutions, discusses the customer-driven design behind the ÄKTA readyflux TFF System 500—built for flexibility, speed, and seamless transition from R&D to commercial production. He also shares how the system aligns with Cytiva’s broader strategy to support decentralised manufacturing and deliver high-quality, future-ready solutions across global therapeutic hubs.

What specific customer insights or unmet needs most influenced the development of the ÄKTA readyflux TFF system 500, and how did these shape the system’s final design? 

The development of the ÄKTA readyflux TFF system 500 was shaped by customer feedback highlighting the need for flexible, scalable solutions to support small-scale GMP manufacturing of advanced therapeutics, including mRNA, viral vectors, monoclonal antibodies (mAbs), and antibody-drug conjugates (ADCs). Customers emphasized the importance of a system that could seamlessly scale from process development to GMP production within a single platform.

Ease of use was another key priority. Customers wanted a simplified setup, handling, and operation, along with predefined phases and methods in the UNICORN software to streamline workflows. The inclusion of a 1/8-inch flow kit was also a direct response to customer requirements for low-volume processing.

As part of the broader ÄKTA readyflux platform, the system was designed to ensure consistency across scales, supporting simplified technology transfer and reducing process variability. These insights were instrumental in shaping a solution that meets the evolving needs of biomanufacturers.

As advanced modalities like mRNA and viral vectors scale, how does the ÄKTA readyflux TFF system 500 balance the need for precision in low-volume applications with the pressure for faster, more flexible production cycles? 

The ÄKTA readyflux TFF system 500 is engineered for small-scale manufacturing of advanced therapies including mRNA and viral vectors while enabling faster, more flexible production cycles through its single-use design. Its low minimum working and hold-up volumes enable efficient purification for low-volume workflows, ensuring high concentration factors and maximizing product recovery. 

To streamline operations, the 1/8-inch single-use flow kit can be quickly installed in less than 15 minutes. This accelerates turnaround between batches, reduces cleanroom downtime, and minimizes the risk of cross-contamination, supporting faster production cycles. 

Process control is maintained through a built-in load cell for accurate weight measurement. In addition, the flow kit has integrated, pre-calibrated sensors for pressure, conductivity, temperature, flow, UV, and pH that enable precise monitoring and control of critical process parameters (CPP) and combined with controlled mixing, ensure robust performance and batch-to-batch consistency. The flow kit is also available in basic and plus configurations to accommodate a range of process requirements.

Technology transfer continues to be a persistent bottleneck in biomanufacturing. How does this new system simplify or de-risk tech transfer across R&D, clinical, and commercial stages? 

The ÄKTA readyflux TFF system 500 is designed to simplify and de-risk technology transfer by supporting consistent workflows and process control across development stages. By using the same system from process development through to clinical and commercial production, biomanufacturers can streamline scale-up and reduce the complexity of transitioning between phases. 

As part of the ÄKTA readyflux portfolio, the system leverages the same single-use technology and integrated UNICORN™ software across systems, enabling scalability and operational consistency. This alignment helps reduce variability between different manufacturing environments and stages of development.

The ÄKTA readyflux TFF system 500’s ease of use, automated control software, and single-use flow kits help ensure process consistency, while built-in sensors and an interactive process picture support precise control of CPPs. This consistency across phases and sites minimizes the risk of delays during technology transfer, allowing teams to move more efficiently through the development pipeline.

The ÄKTA readyflux TFF system 500 brings the same operational simplicity as the ÄKTA readyflux to smaller-scale workflows, enabling a unified approach to both upstream and downstream purification, streamlining transitions across modalities and manufacturing scales.

Could you elaborate on the role of the UNICORN™ software in the context of workforce efficiency—especially for smaller biotechs that may lack deep programming expertise? 

UNICORNsoftware plays a key role in improving workforce efficiency by simplifying system operations and method development, particularly for smaller biotechnology companies that may not have specialized programming resources. Its interface allows users to create and run methods without coding, while the interactive process picture enables real-time monitoring and comprehensive control of CPPs. 

The software includes a library of pre-defined method phases that can be used directly or adapted as templates, making it easier to develop customized methods tailored to specific process needs. This reduces setup time, shortens onboarding time for new users, and minimizes the risk of operator error for consistent execution across teams and sites.

In what ways does the ÄKTA readyflux TFF system 500 align with Cytiva’s broader strategy for enabling decentralised or distributed manufacturing, particularly in emerging markets or cell and gene therapy hubs? 

The ÄKTA readyflux TFF system 500 aligns with Cytiva’s broader strategy to enable decentralized and distributed manufacturing, particularly in emerging markets and cell and gene therapy hubs. Its compact, benchtop design reduces facility footprint requirements, making it ideal for cleanroom environments where space and infrastructure are limited. This flexibility allows the system to be deployed across a range of settings – from centralized facilities to smaller, regional manufacturing sites – supporting scalable and modular production models.

The system also features a ready-to-use, single-use flow kit that simplifies setup and minimizes the need for cleaning and validation between runs. This not only reduces turnaround time and operational complexity but also supports the agility required for decentralized manufacturing models.

By simplifying operations and integrating readily into existing workflows, the system enables drug developers to establish localized manufacturing capabilities, accelerate timelines, and reduce logistical complexity. The ÄKTA readyflux TFF system 500 helps bridge the gap between innovation and accessibility, reinforcing Cytiva’s commitment to advance and accelerate therapeutics.

Looking ahead, how does Cytiva envision evolving the ÄKTA readyflux platform further—whether through automation, data integration, or modularity—to meet the evolving needs of the biopharma industry?

Since the introduction of Cytiva’s first single-use tangential flow filtration (TFF) system in 2017, the ÄKTA readyflux platform has continued to evolve, expanding to support both larger and smaller-scale applications. The launch of the ÄKTA readyflux TFF system 500 marks the next step in this journey, delivering efficient purification for small-scale GMP manufacturing, while maintaining the intuitive user experience the platform is known for.

Looking ahead, Cytiva  is  committed to advancing the ÄKTA readyflux platform to meet the changing needs of the biopharma industry. Future developments will continue to focus on flexibility, scalability, and ease of use, ensuring the platform can adapt to a wide range of manufacturing environments and therapeutic modalities. As the industry continues to evolve, Cytiva is focused on delivering innovative, future-ready solutions that empower customers to bring advanced therapeutics to patients safely and efficiently.