OPC UA for Sample Process Automation – Improving Data Harmonization for Biobanks and Cell and Gene Therapies

Data mustn’t sit still. It is imperative that information can be exchanged within machines, between machines and from machines to systems where it is secure in order for researchers to read their data. To improve connectivity and enable efficient and secure exchange of data, Thermo Fisher Scientific now offers the CryoMed™ Controlled-Rate Freezer with Open Platform Communications Unified Architecture (OPC UA) functionality.

Technology Networks had the pleasure of talking to Wilfredo Marín, senior product application specialist from Thermo Fisher Scientific, to learn more about OPC UA and how it is suited to biobanking and cell and gene therapy development. In this interview, Wilfredo also highlights the benefits of incorporating OPC UA into the CryoMed Controlled-Rate Freezer, and the importance of OPC UA functionality in the lab of the future.

Zoe Braybrook (ZB): Can you briefly describe what OPC UA is and the benefits it offers?

Wilfredo Marín (WM): Sure, OPC UA stands for Open Platform Communications Unified Architecture allowing for information exchange in a standardized manner. This means that it is a well-organized and defined protocol allowing for interoperability of instruments. The benefits include flexibility to work across operating system platforms, data security and scalability as the data is transformed into information. In industrial settings, OPC UA offers end-users the building blocks to fit into their control system workflows.

ZB: OPC UA has already been successfully integrated into other industries including food and beverage as well as energy and utilities, could you perhaps discuss how you think it’s suited to biobanking and those producing cell and gene therapies?

WM: It certainly has been integrated in many other industries as they can make better and faster business decisions using insights from the accessible information. That is the key to OPC UA, as it follows industry advised companion specifications to provide contextualized data in a process system. For biobankers, it helps support the sample traceability, standardization and documentation process that is sought for collaboration. As these researchers look to modernize their facilities and potentially grow operations within a building information management system, OPC UA functionality in their equipment offers similar advantages as having biomaterial with associated clinical data.

For cell and gene therapy production facilities, cryopreservation is a vital step to maintain the integrity of cells being modified, stored or distributed. Having a controlled-rate freezer with OPC UA integrates nicely as a server to communicate with several types of client programs they currently utilize.

ZB: Why did Thermo Fisher Scientific choose to incorporate this function into the CryoMed Controlled-Rate Freezer in particular?

WM: Thermo Fisher Scientific is continually at the forefront of innovation that enables our customers to succeed. The investment into research and development is tremendous and our same customers provided valuable feedback to support how we implemented OPC UA as the previous updated model was being launched. As a former end-user, the CryoMed Controlled-Rate Freezer was a great choice to update as an instrument that is necessary for several important research and production workflows. Cryopreservation of biomaterial is performed at several points, so it was vital to maintain the precision performance and reliability that the CryoMed is known to deliver.

ZB: How does CryoMed provide researchers with modern connectivity but also ensure their data remains safe?

WM: The CryoMed has several options to connect in a research setting including wireless remote monitoring, PC-connected remote control and now OPC UA functionality. It was also one of the first cryopreservation products to meet 21 CRF Part 11 requirements by the FDA for electronic records. On the new user-interface, as a starting point, the updated firmware asks for unique usernames with passwords, defines user roles and retains audit and event logs. Taking a step further, OPC UA also has security built into its protocol for access control, authentication and encryption. So, in a control system, there will always be rules between different levels to connect, find and read data as information.

ZB: What factors should labs wanting to improve their processes consider with regard to OPC UA adoption? How easy is it for labs looking to improve their processes to adopt OPC UA products?

WM: One factor that we continue to highlight is that OPC UA communication has been well-supported and industry-approved over several years. The Unified Architecture has evolved as a successor of classic OPC with emphasis on platform independence, security and integration. Therefore, a product with OPC UA like the CryoMed can be easily deployed to enhance efficiency of their process. For laboratories, a real advantage applies when looking to scale for production requiring GMP. It can turn a very manual method into closely documented automatic outputs between multiple machines as it orchestrates data. OPC UA can be easily adopted but requires the same future mindset we attribute to biosamples having the potential for discovery or therapies.

ZB: How important will OPC UA functionality be in the lab of the future?

WM: With the fast-moving pace of technology and associated expenses, labs are looking to future-proof by incorporating sustainable planning into their operations. We’re thinking ahead to how various instruments in the same workflow can communicate and support manufacturing with OPC UA as a framework in the industrial internet of things. Through these efforts, there will be more products developed that utilize OPC UA making it easier to exchange the compliant and contextualized data, thus maintaining high-quality at lower costs. Altogether, the lab of future will be able to use information from these physical machines for predictive analytics by modeling data to provide several paths for success.

Wilfredo Marín was speaking to Zoe Braybrook, Marketing Campaign Coordinator for Technology Networks.