Automation For Consistency

Automation and single-use equipment

Alongside the increased speed, efficiency, and economy of single-use bioprocessing technology comes an important challenge – automation, and the data integration it allows. Successful single-use biomanufacturing strategies are designed with data and connectivity in mind.

Our approach to automation

Single-use technologies can be more challenging to automate, but the benefits more than outweigh the costs. That is why we are determined to lead the way in developing efficient, future-proofed automation strategies. To do so, we have analyzed exactly where the benefits of automation lie and how they can be maximized.

In this article, we take a look at some key takeaways from our white paper on improving operational efficiency through automation.

The value of connectivity

Why data is important

Throughout the biomanufacturing process, high-quality data helps you ensure that production is consistent and complies with regulatory requirements. It allows for:

• streamlined batch release
• better instrument control
• coordination throughout a manufacturing plant
• more informed business decisions

Closing automation gaps

Biomanufacturing can be a world of islands. Small-scale automation with no connectivity between processes, lack of coordination, and fragmented data. Disconnects can arise at all levels, including between:

• individual pieces of equipment
• different production scales
• upstream and downstream process development
• separate company departments and facilities

At a bare minimum, your system should allow you to export data from different areas into a single format (such as a spreadsheet). But that still leaves a lot of manual entry and analysis to do. At each stage, there is the opportunity to make the data more accurate, more useful, and easier to integrate. The key to closing these gaps is the appropriate choice of bioprocess equipment.

Choosing the right equipment

The development stage

During product development:

• researchers are usually working at bench scale
• there may be several drug candidates
• there is usually little or no automation infrastructure
• data comes from supplier instruments and controllers built into the equipment

Equipment used at this stage should be modular and flexible. It is vital to select an equipment supplier capable of providing multiple unit operations on modular product platforms which enable data collection/capture.

The manufacturing stage

Things change markedly between the development stage and manufacturing stage:

• there is usually a more developed automation infrastructure
• data might come via a custom-designed system or industry-standard hardware and software
• production methods depend on data imported from the development stages

During manufacturing, the more integrated your system, the more effective your data management will be. Equipment should allow easy scale up from development processes.

Ideal automation solutions are wide-ranging

An ideal automation solution spans the complete upstream-downstream bioprocess train. The data it produces has far wider implications for data management and process control. A comprehensive automation solution can lead to improved efficiency across all functions, such as:

• production
• material management
• quality control
• procurement
• finance

What Cytiva offers

• Modular bioprocess technologies, both hardware and consumables, with easy integration and connectivity
• FlexFactory integrated single-use bioprocess platform
• Technologies designed for efficient scale-up and scale-down
• Technical experts to help with scaling and converting stainless steel processes to single-use
• Automation and integration expertise