Xertified XoT devices to secure life science equipment

It was obvious from the first meeting that there is a case for Xertified to secure vulnerable life science equipment. Promising cyber security improvements in fifteen minutes or less seemed like an interesting promise, stretching what I thought was even possible. One week later we are all much wiser, this is what we learned.

Xertified and Biotage ran a one-week test in the Testa Center to test if their “XoT solution” could improve the cyber security posture of life science equipment. Another goal for the project was to learn about customer demands on cyber security in life sciences.

During the week Xertified and Testa Center ran test cases with the XoT-device using the Cytiva Xcellerex Disposable Reactor 50 liters, the ReadyToProcess Wave25 bioreactor, an ÄKTA ready flux instrument, the Applikon/Getinge Easy Controller 2 tower and bioreactor, as well as a Mettler Toledo IND570 floor scale.

Test and interviews for cyber security insights

Tests were conducted to try out communication, functionality, and to reduce cyber security attack surfaces. The team also conducted interviews with participants and stakeholders to learn about life science and biotech demands on cyber security. A discussion was held with subject matter experts on cyber security implementation, instrumentation development, customers’ feedback, as well as on remote service and maintenance.

Reduced attack surface

The tests revealed that most instruments in this test received cyber security benefits from utilizing the Xertified offering using XoT-devices and management systems.

Happy faces from left to right, Martin Eriksson, Mats Loman, and Mattias Waldau, after successful tests on the XDR 50.

Universities and small-medium businesses could be the early adopters

From the interviews, it was derived that the typical “big-pharma” customer usually has an IT department with in-house cyber security expertise. It was also found that the “big-pharma” customer normally does not allow for the introduction of new devices after the manufacturing process has been deployed, verified, and in production. The interviews revealed that universities usually are early adopters of new technology and usually work in cyber security risk environments as their lab often gives open access to students and researchers even as they work with forefront research. On the other hand, universities tend to be price sensitive.

The best fit for the XoT solution in life science equipment seems to be to support equipment and instruments that are sold to the small and medium business (SMB) segment. The SMBs usually have a basic to an above-average understanding of cyber security and understand the need for improved security if it comes as a combined or integrated solution.

Other findings

We also found a lot of ideas for new features on the XoT device, the client package, and the management portal that would be beneficial for the life science industry.

The original time plan was adjusted during Tuesday as the RTU (real-time unit), ÄKTA Go, Pure, and Pilot 600 was ruled out from the original test plan due to their network design. Time ran out while we were testing the ReadyToProcess Wave 25, so the results are inconclusive on that specific device.

Improved security in fifteen minutes?

So, did we get the improved cyber security posture in just fifteen minutes per instrument? Not for the first or second instrument, but for the third and fourth, yes, we did!

We also learned about the reasons why very few labs and even fewer process manufacturers allow for public internet access to the control systems, even when the users demand it.

With the learnings from this project, Xertified should soon be able to make it possible for labs to securely use more Internet-connected instruments and services in the labs, by using their XoT technology.

November 19, 2021November 19, 2021

Making a difference for cancer patients

Angelica Loskog’s area of research is cancer, specifically, chimeric antigen receptor (CAR) T-cells, which she began to study as a postdoc at the world’s largest cell and gene therapy center, the Baylor College of Medicine in Houston, Texas. Today she is CEO of Uppsala-based Lokon Pharma, which is attempting to combat tumors with the help of oncolytic adenoviruses. Their first gene therapy candidate, known as LOAd703, is already being clinically tested and evaluated for several different cancers; pancreatic, ovarian, colorectal, biliary tract and melanoma.

Now Lokon Pharma has managed to scale up its manufacturing process and demonstrated that it works reliably. They are more than happy with the results gained after just nine weeks at Testa Center.

– We have achieved fantastic results in a very short time. We spoke directly with all the expertise at Testa Center, utilizing their broad know-how as a filter in direct discussions with people familiar with our own company’s specific project needs. This paved the way for success. We have, for example, being able to run tests relevant to just our particular product.
Angelica Loskog, CEO at Lokon Pharma.

Together with Testa Center staff, Lokon Pharma has ‘set the stage’ and obtained a good overview of the manufacturing process, thereby becoming experts in their product. It’s cool, comments Angelica, emphasizing that the time spent at Testa Center was particularly valuable in securing a robust CMC (Chemistry, Manufacturing and Controls) road map for their process.

– We can now state with certainty what the CMC should look like and that’s a fundamental basis for market approval. In all the excitement of collecting clinical data, it can be easy to forget that you still need effective and reproducible products!

Angelica also emphasizes the contribution of Lokon Pharma’s own CMC expert, Sara Häggblad. Her knowledge and experience have also been crucial for the success of the project. Before Lokon Pharma, Sara was an adenovirus expert within CMC at Cytiva. She now believes that their newfound success at Testa Center can provide a better understanding of this type of adenovirus product – specifically, that it can be produced reliably at a large scale.

Sara Häggblad and Titti Björnström in the office..

Previously, process development of this type has been driven by big international players – the industry’s dragons – but this ‘homegrown’ success story shows that neither large nor specialist facilities are essential. Angelica also believes that it will be easier for Lokon Pharma to engage with manufacturers now that they know their process inside out. In other words, it will be easier to guide production partners correctly and that, in turn, will have a great impact on the result.

– When you understand exactly what to do. Uncertainty disappears. Having our process verified at Testa Center is pure risk minimization. It’s also a seal of quality. Testa Center is an incredibly important bridge that leads from academia straight into industry. Its value cannot be overstated. Cell and gene therapy has always been strongly grounded in academia, but now I firmly believe in a future shift towards large-scale manufacture, broader application in cancer treatment, and greater patient benefits, concludes Angelica Loskog.

October 19, 2021October 19, 2021

Process control experiment by master students in the Testa Center

Professor Bengt Carlsson reached out to the Testa Center in February 2021 with an ask. “Would it be possible to have students in the Testa Center using bioreactors to learn PID control?” he asked, yes, certainly we said.

After two short visits to the laboratory and Bengt and the Testa Center staff prepared the experiment instruction for the students. And when the time came, in October that year, the first students arrived and successfully performed the lab. The students were thrilled to use real-world, industry-grade, bioreactors. And when the PID parameters had been fully optimized, then everyone, including Bengt, went home with new knowledge of hands-on control of bioreactors and big smiles on their faces.

Professor Bengt Carlsson, Department of Information Technology, Division of Systems and Control at Uppsala University. Explains why his students are in the Testa Center.

“Normally we use a lot of simulation exercises … it’s not the real thing, and here they could really try the method on the real process”.

Bengt Carlsson, 2021.

Testa Center embraces academic work in life science. We love to work together with academia and other educational organizations to secure excellence in the life science sector. Would you like to know more, please read another testimonial or get in contact with us.