Step into the future of chromatography automation

Downstream processing has changed dramatically over the last few decades. It used to depend on manual work and local control; now it’s a complex, data-driven process that must scale across development, pilot, and GMP manufacturing. New integrated and continuous approaches increase the need for strong automation, control, and coordination across steps (1, 2).

Even with these advances, chromatography is still challenging to automate effectively. It must stay flexible during process development but stable during production.

UNICORN™ 8 software, combined with module type package (MTP) technology, reflects a practical shift in how the industry is addressing this challenge. This change brings together usability, flexibility, and integration in a way that aligns more closely with how biomanufacturers work.

Turning data into better decisions without adding risk

Katarina Stenklo, senior product manager, global FlexFactory™ platforms, explains that while automation has improved, the biggest change in downstream processing is the growth and importance of data. Bioprocessing now uses more digital tools and large amounts of data across development and manufacturing. This drives the need for better control and clearer visibility across the process (2).

As pipelines grow and timelines shrink, teams handle more data earlier and must carry it into manufacturing without problems. At the same time, the industry remains cautious about making changes that might disrupt their production lines. GMP environments prioritize tightly controlled, validated processes to protect product quality and meet regulations (3).

Keeping the familiar while reducing the skill burden

In the 1990s, the industry moved from paper-based data capture and adopted digital records. Software such as UNICORN™ control software was introduced for control and analysis of chromatography runs. Since then, the software has evolved with the industry. Version 8 keeps a familiar look while adding new features based on customer needs. That familiarity helps teams run processes the same way every time. This is important in regulated settings, where mistakes can add cost and compliance risk.

Manufacturing also faces a high risk of human error. Many errors come from how systems are designed and how people use them, not just from individual mistakes (4, 5).

Asked to explain the updates to UNICORN™ 8 software, Greg Withers, bioprocess hardware automation specialist, says, “We can do more, but I don’t have to be more skilled to do it. That’s not true of every other automation platform.”

Using an interface design that flexes for all operator skill levels while adding higher capacity helps improve reliability and keep processes consistent.

Designing for how people work

Manufacturing and MSAT: balancing flexibility and control

Manufacturing and manufacturing science and technology (MSAT) teams need to adjust quickly while keeping processes validated and production running. Traditional automation can slow things down and make changes hard to manage.

Greg says, “Manufacturing managers absolutely care about downtime…distributed control systems take a long time to deploy, and once they’re in, they’re very inflexible.”

This reflects wider industry challenges with older systems and complex integration, especially when linking new equipment to plant‑wide platforms (3).

The approach with UNICORN™ software—controlled flexibility—helps teams move faster while staying in control of their process.

Operators: reducing risk at critical steps

Operators play a key role, and set-up and start-up are particularly risky. In GMP settings, human error is still a common cause of deviations and quality issues (6).

UNICORN™ 8 helps by building guidance into workflows and reducing how much operators need to decide.

Fig 1. An operator using UNICORN™ software in a GMP environment.

As Greg explains, “Operator concerns are mostly about usability… I need to perform my functions, so the purified material meets its critical process parameters.”

New features are designed to lower the risk of errors. Reducing how much runs rely on manual steps helps reduce variation and makes results more consistent (4, 6). This also gives operators the confidence that they can deliver what is needed.

Building compliance into everyday workflows

Regulatory expectations are built into every step of pharmaceutical manufacturing. Systems must support data integrity, traceability, and audit readiness.

Regulators require data to be complete, consistent, and secure, with a clear record of who did what and when. Systems must also meet requirements such as 21 CFR Part 11 and GMP Annex 11 for electronic records and audit trails (7, 8).

Automation is critical to meeting these needs. Digital systems help reduce manual errors, enforce consistent steps, and capture detailed records automatically.

From a system view, this includes:

• Time-stamped records of actions
• Role-based access control
• Data integrity protections
• Validated and qualified systems

At the same time, expectations are expanding to include data governance, cybersecurity, and lifecycle management of systems.

Systems that build compliance in by design help teams stay inspection-ready with less effort. UNICORN™ 8 with MTP supports this approach.

Enabling simple yet flexible integration

Integrating chromatography into plant‑wide automation is still a challenge. Older control systems can be hard to connect with newer equipment; the reverse is also true (3).

MTP helps solve this with a standard, modular approach. It defines how modules connect, share data, and work with control systems (4, 9). This supports the move toward modular manufacturing and “plug‑and‑produce” setups, where prebuilt units can be added or updated with less effort (10, 11).

The result: more flexible, scalable automation without the need for large system redesigns.

Need more information on what MTP is and how it works? Click here.

Driving a more connected and controlled future

Where is chromatography automation headed? According to Katarina, “You will not have one supplier of instruments…you need to pick the best of the best…so in that sense it becomes more plug and play.”

Biomanufacturing is becoming more modular, connected, and data‑driven. But it still needs to stay easy to use, reliable, and compliant.

UNICORN™ 8 supports this shift by:

• Keeping a familiar interface while adding new capabilities
• Building guidance into workflows to reduce errors
• Supporting data integrity and traceability for compliance
• Enabling modular integration through MTP

Together, these features help solve long-standing challenges in chromatography automation – making processes faster, reducing risk, and supporting compliance, all without adding complexity.

What is module type package (MTP) and how does it work?

Put simply, USB drives and MTP files work in much the same way – They're both universal. For the most part, you can plug any USB drive into any laptop, and the laptop can read what’s on the drive. An MTP file brings that same plug-and-play simplicity to chromatography: any MTP-enabled automation layer can recognize a chromatography skid controlled by UNICORN™ software version 8, without the need for extra coding.

When MTP is implemented, a chromatography skid from Cytiva can be controlled either in UNICORN™ software or in the MTP-enabled automation layer (Fig 2).

Fig 2. The flow diagram for ÄKTA process™ system can be displayed via the interactive process picture in UNICORN™ control software using a Rockwell PLC (top), and the same system in zenon software MTP POL (bottom left). On bottom right is the flow diagram for the previous ÄKTAprocess™ system using a CU-960 controller. PLC is programmable control logic. POL is process orchestration layer.

Details on module type package

MTP lets equipment “describe itself” in a standard way, so it can plug into a larger system and work right away. It shares what the machine can do, how to control it, and what data it sends, so any compatible system can understand it. MTP uses open platform communications unified architecture (OPC UA) as the communication method to exchange data, services, and alarms between systems.

This enables what’s known as plug-and-produce. You import an MTP file, and the system understands the equipment without custom setup. The machine runs on its own, while a higher system simply coordinates it.

How it works (step by step):

1. The supplier provides an MTP file for the machine.
2. You import the file into your control system.
3. The system reads the machine’s functions, data, and services.
4. You connect services and set up the process.
5. The system sends simple commands (start/stop), while the machine runs independently and shares status, data, and alarms via OPC UA.

Cytiva is collaborating with COPA DATA to develop and implement the MTP technology into the UNICORN™ control platform. Figure 3 shows how to use MTP with UNICORN™ v8.

Fig 3. What you need to use MTP functionality with UNICORN™ software. GW is gateway.