Expert Voices: Why Aren't QC Labs Fully Automated Yet?
By David Wolton
In theory, the use of robots and automation to fully automate biopharma QC labs should be quite simple. The samples rarely exceed 50 ml, technology is readily available to remove and replace lids, containers are now being produced pre-bar coded. So, if the technology is available why are we not seeing fully automated QC laboratories?
The Laboratory Automation Plug and Play (LAPP) body has been set up to lobby both suppliers and end users regarding the need for plug-and-play automation in pharmaceutical quality control laboratories. This article highlights some of the views of industry experts involved in this initiative.
In your opinion, why is automation not happening in quality control laboratories to any great extent?
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There are probably a lot of different company-dependent reasons but the two I have heard the most during conferences and similar events are the following: • QC automation means validation and qualification, and, to some, it is considered too complicated and risky. • Some companies do automate processes; however, it is mostly in manufacturing related areas. These areas are considered the core areas and QC is considered to be a service. Miguel Alvarino — Lonza |
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Why is the current automation too expensive for most labs?
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The lack of standardization in instruments and methods leads to many automation technologies needing extensive customization (hardware and software) before they can be used. Customized systems are also more expensive to validate in GxP environments. Kurt In Albon — Lonza |
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Building an end-to-end automation system currently demands extensive customization. Creating retrofitted interfaces — both hardware and software — to accommodate today’s heterogeneous landscape is highly complex. Adam Wolf — Takeda |
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What would you recommend to create a paradigm shift?
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Enabling plug-and-play automation and, with this, a democratization of it! Tom Kissling — Roche |
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We need to educate instrument manufacturers on the importance of the data and encourage them to use standard Ethernet-based protocols such as OPC UA with standard instrument ontology such as Allotrope. Eugene Tung — Merck |
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To create a paradigm shift, promoting standardization and interoperability is essential. Developing plug-and-play systems that can easily integrate with different lab devices and workflows would reduce complexity and lower costs. Additionally, using digital twins and standardized communication protocols would help automate labs more efficiently. Adam Wolf — Takeda |
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Should trained mechatronics specialists be present in the analytical development departments?
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Most certainly. These are the people working in tandem with the software engineers (or the external suppliers) to keep the automation running. Any highly automated lab relying only on external service technicians will ultimately run into situations where automation comes to a standstill because of mechanical, electrical, or software problems. In these cases, having experienced personnel on-site who are familiar with the custom or off-the-shelf automation equipment will be crucial — especially since nothing, really, is ever fully off-the-shelf. Kurt In Albon — Lonza |
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If the aspiration is to develop an automated laboratory, then the answer is a resounding yes. Eugene Tung — Merck |
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Interdisciplinary skillsets are more essential than ever across organizations. In analytical development, lab scientists and automation experts must collaborate closely to design both analytical methods and the supporting automation platforms. Mechatronics serves as a prime example of a versatile engineering discipline, blending mechanics, electronics, and information technology. By incorporating pharma-specific expertise into this mix, organizations can significantly enhance efficiency and innovation. Adam Wolf — Takeda |
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What are your views on the development of competing software standards?
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More standards are better than none, but in my opinion, too many standards can undermine the efforts. Christian Stirnimann — Roche |
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Standards do not compete — it's better to have more than one standard, but it is essential to have one and that it will be accepted and implemented by the vendors. Tom Kissling — Roche |
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It's encouraging to see progress in the community toward standardization, with various initiatives taking shape. Several efforts to develop lab-specific communication protocols are emerging and gradually gaining traction among suppliers. SiLA and OPC-UA LADS, for example, demonstrate how two different approaches can tackle the same problem from distinct technological and historical perspectives. Each protocol has its own strengths and weaknesses, with the primary challenge being widespread adoption. To fully realize the benefits of harmonization, one protocol will likely need to prevail as the dominant, ubiquitous standard. Adam Wolf — Takeda |
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Conclusions
There are a number of messages here for both the end users and the suppliers.
- The organizational structure of pharmaceutical companies must change from the top down. Mechatronics needs to be given the same status as data and digital.
- Analytical development needs to deliver both automated assays and validated assays.
- There are developments in regard to developing standards; however, it is in no one’s interest for them to compete, especially for the equipment suppliers.
- To create the paradigm shift, we need plug-and-play functionality between the robotics/automation and the analytical equipment it interfaces with.
About The Author:
David Wolton is an independent biologics manufacturing consultant based in Zurich. He has decades of experience managing teams, designing equipment, and designing facilities. He specializes in single-use equipment, automation, and mobile robotics.