Nearly two decades ago, single-use chromatography was considered a bold idea. Since then, single-use technologies have moved from a niche concept to an accepted part of modern biomanufacturing. The conversation is no longer about whether single-use chromatography works. Today, manufacturers are asking a different set of questions:
- How can we reduce operator dependency?
- How can we connect chromatography systems to increasingly digital facilities?
- How can we support more modalities without adding complexity?
For manufacturing science and technology (MSAT) teams, these questions have become central to daily operations. As production environments grow more diverse and manufacturing strategies become more dynamic, chromatography systems must do more than run a purification step. They must help organizations operate with greater consistency, versatility, and confidence.
Three challenges are shaping the next generation of single-use chromatography.
Challenge 1: Turning operator confidence into operational consistency
Experienced operators are one of manufacturing's greatest strengths. They often spot issues before alarms appear. They know the difference between normal process variation and true process risk. And they’re often the people teams rely on when something unexpected happens.
The challenge isn’t replacing that expertise; it's helping every operator work with the same confidence and consistency.
As organizations grow, they regularly onboard new employees, transfer processes between teams, and run operations across multiple shifts and sites. Success can no longer depend on a single experienced operator standing in front of the system. Process knowledge must become embedded in the workflow itself.
Many users tell us that single-use chromatography still requires substantial oversight, especially during setup. Installing flow kit manifolds, preparing systems, and configuring runs all create opportunities for mistakes. Even when those mistakes don't affect product quality, they can trigger investigations, documentation reviews, and quality oversight that consume time and resources.
The goal isn't just to prevent major failures; it's to reduce the many small disruptions that slow manufacturing down.
That's why the design of single-use chromatography systems is changing. Instead of expecting operators to remember every step, manufacturers increasingly want systems that guide users through critical tasks, verify setup steps, and automate routine documentation.
The next-generation ÄKTA ready™ platform, which is called standard configured system (SCS) (Fig 1) was developed with these challenges in mind. Features such as software-guided flow kit installation, automatic flow kit recognition, real-time setup feedback, and automated batch record support all aim to make critical setup activities easier to perform consistently.
Fig 1. ÄKTA ready SCS.
The preassembled, one-piece flow kit can be installed by one person in less than ten minutes without tools. Barcode scanning transfers flow kit information directly into the software, helping reduce manual entry and streamline configuration. Built-in sensors verify correct installation, while digital usage tracking through a device logbook helps support documentation and traceability.
The goal isn’t simplification for its own sake – it's consistency. Because the more consistent the process, the more time MSAT teams can spend improving manufacturing instead of managing setup and oversight of runs.
Challenge 2: Bringing chromatography into the connected facility
As facilities become more digital, chromatography systems are expected to be part of a larger manufacturing ecosystem.
Teams want easier access to process data, stronger traceability, electronic records, and equipment that fits into broader automation strategies. Achieving that is more complex than it seems.
Most manufacturing facilities have unique automation environments. Distributed control systems (DCS), software platforms, and technology standards vary from site to site. As a result, equipment integration can become a major engineering project before production even begins.
At the same time, expectations continue to rise. Manufacturers want equipment that exchanges data easily between sites or with CDMO partners, connects to other systems, and supports digital manufacturing strategies without extensive custom work.
As a result, chromatography is increasingly being viewed not as a standalone unit operation but as one part of a connected manufacturing process.
UNICORN™ software version 8 was designed to help support that shift. New capabilities support data handling, digital traceability, and connectivity across manufacturing operations. These include device logbooks*, barcode-enabled batch records*, application programming interface (API) to allow access to process data in the UNICORN database, and support for module-type package (MTP).
Note: * These features are currently only available when using UNICORN 8 with ÄKTA ready SCS.
The software can also connect with external equipment to help create more integrated workflows. MTP support can simplify integration with automation platforms, helping facilities connect systems in hours rather than weeks and with less engineering effort.
Additional capabilities help support regulated manufacturing environments. New GxP licensing builds on support for 21 CFR Part 11 and other regulatory requirements, while database and cybersecurity updates help support modern digital manufacturing strategies.
For MSAT teams, the benefits extend beyond integration. Connected systems can improve visibility, speed troubleshooting, strengthen data integrity, and support ongoing process optimization.
The goal isn't simply automation – it's interoperability.
Challenge 3: Supporting more modalities without creating more complexity
One of the biggest changes in biomanufacturing is the growing diversity of therapies moving through development and manufacturing.
The original ÄKTA ready™ system was launched into a 2008 world dominated by monoclonal antibodies and relatively predictable purification requirements. It was simple (280 nm, mAb-focused work) with homemade sensors since suitable electronics weren't yet available for single-use equipment. Today's landscape includes viral vectors, mRNA, plasmid DNA, oligonucleotides, antibody-drug conjugates (ADCs), and other emerging modalities.
The manufacturing challenge is obvious: Manufacturers need equipment that can adapt. Different processes require different operating conditions, chemistries, flow rates, and purification approaches. At the same time, few manufacturers want separate equipment for every molecule type.
That reality is changing the meaning of versatility.
Early single-use systems focused on disposable flow paths and faster changeovers. Today's manufacturers need flexibility across modalities, process intensification strategies, automation architectures, and future manufacturing requirements – without dramatically increasing equipment footprint.
Historically, customization was often the answer. But customization can introduce its own challenges, including additional engineering work, more validation, longer lead times, and ongoing support requirements. Many MSAT teams want broader capabilities built into the platform instead.
That approach is reflected throughout the ÄKTA ready™ SCS platform. These systems support two flow kit sizes on a single skid, expanded chemical compatibility for NaOH cleaning and solvents used in ADC manufacturing, along with multiwavelength UV detection.
An innovative drip-free diaphragm pump, produced by LEWA, helps reduce operator exposure to viral vectors and solvents used in ADC manufacturing while handling sensitive molecules gently. The new pump includes a leak sensor and compartment to ensure operators aren’t exposed to any residual solutions in the flow path tubing when it’s removed. Improved sensors, redesigned valves, and an updated flow path support reliable performance across a wide operating range. Isolation valves help prevent unintended fluid mixing and support greater process consistency.
The platform is also designed to support future process intensification approaches such as inline dilution with a third pump, normal flow filtration (NFF), and twin-column chromatography for process intensification.
The goal is not only to support today's processes but also to help manufacturers adapt as requirements evolve. In modern biomanufacturing, change is no longer the exception — it's expected.
Tomorrow's single-use chromatography
The first generation of single-use chromatography helped manufacturers reduce the burden of cleaning and changeovers.
The next generation is focused on helping teams work more consistently, connect more easily within digital facilities, and adapt to changing manufacturing needs.
For MSAT teams, the challenge is keeping pace with an increasingly dynamic manufacturing environment. The opportunity is access to systems designed not only for today's processes but also for whatever comes next.