From Single-Use to Continuous Bioprocessing: Sartorius Pioneers the Future of Biomanufacturing
Biopharmaceutical manufacturing is entering its next major transition. After helping move the industry from stainless steel to single-use, Sartorius is once again pioneering the next step: Connecting technologies to enable more integrated, continuous and data-driven bioprocesses. The aim is clear: make biomanufacturing more flexible, efficient and scalable - and help bring innovative therapies to more people.
This article is posted on Sartorius Blog.
For decades, biopharmaceutical manufacturing was shaped by stainless steel: fixed installations designed for scale, but not always for flexibility. When single-use technologies entered the industry, they were often seen mainly as suitable for process development and clinical phase manufacturing.
Rethinking Biomanufacturing
Sartorius took a different view. Early on, the company recognized that single-use technologies could do more than replace individual stainless-steel components. They could help make biomanufacturing faster to set up, less capital-intensive and more adaptable to changing production needs. Or to put it in numbers: They could reduce capital costs by around 70 percent and labor costs by around 40 percent, while increasing flexibility and efficiency.
When we started focusing more on single use in the early 2000s, many in the business didn’t expect it to play a role beyond development. However, once its scalability and reliability had been proven, it rapidly became a cornerstone of modern biopharmaceutical manufacturing.
René Fáber, Member of the Executive Board at Sartorius
Today, Sartorius is a leader in the field, and single-use technologies are established in around 85 percent of bioprocesses in clinical development. In commercial manufacturing, however, the share is still below 20 percent — pointing to significant potential for broader adoption at large scale.
Two developments are supporting this shift. More than half of the therapies currently in development are produced in smaller volumes, while biosimilars are also on the rise. Both trends increase the need for more flexible and efficient manufacturing. “Looking ahead, we see strong potential for commercial adoption to increase to up to 45 percent”, Fáber adds.
But as particularly upstream processing has become more productive due to single-use adoption, the next bottleneck has moved into focus: downstream processing, where the product is separated, purified and prepared for further use.
From Batch Production to Connected Processes
This is where the next industry transition is taking shape - from batch-based manufacturing toward intensified and continuous processes. And Sartorius is at the forefront of this shift once more.
Together with Sanofi, Sartorius is developing and commercializing Pionic®, a modular end-to-end platform for downstream process intensification. It connects processing steps that have traditionally been operated separately, allowing materials to flow through modules in a more integrated workflow. This can increase productivity by up to threefold, reduce cost of goods by up to 50 percent, lower the manufacturing footprint by up to 60 percent and reduce CO₂ emissions by up to 20 percent.
In May 2026, Sartorius reached an important milestone: multiple Pionic® modules were operated together as one coordinated downstream process over 72 hours, showing that continuous, connected downstream processing can move from concept to practice.
Our goal was always to make the systems work as one – not just side by side, but as a coordinated process. This milestone proves that this level of integration is possible in the industry.
Niclas Storck, Head of Automation Platform Development
The significance lies not only in the individual technologies, but in how they are brought together. Biobrain® provides the automation and orchestration layer that helps coordinate the modules and connect upstream and downstream processing through one platform. Process Analytical Technology supports real-time monitoring, while SIMCA® and AI-enabled data analytics help interpret process data, detect deviations earlier and improve process understanding.
With this breakthrough, Sartorius is taking a pioneering step towards connected downstream processing. We are demonstrating a new level of integration that is only now emerging in the industry.
Jan Schäfer, Head of Process Solutions
