Tenboron is a Finnish biopharmaceutical company developing boron carrier substances. Boron carriers are needed for boron neutron capture therapy (BNCT) which is a treatment for cancer. At the moment, the company has three development projects under way, and the one on the antibody-boron conjugate molecule has advanced the furthest. The boron carrier part of the innovation is manufactured at the Medfiles laboratory.
Tenboron started working with Medfiles in 2015, once the boron carrier had been selected and Tenboron had visited the laboratory and production facilities in Kuopio.
“We hit it off immediately. We got off to an easy start in our cooperation and things started rolling from there,” says Juha Jouhki, CEO of Tenboron. Juha’s task is to make sure that Tenboron’s development programmes are making progress and that they are adequately resourced. He is also responsible for acquiring the needed resources as well as communicating the progress of the projects to the various stakeholders.
Jari Helin, Head of CMC, works at Glykos Finland Oy, to which Tenboron has outsourced its product development. Jari is one of the main inventors of the boron conjugate molecule manufactured at Medfiles and leads the molecule development project. Jari is responsible for the production and availability of the investigational product.
“From time to time I get to work at Medfiles’ Kuopio site, where Glykos is responsible for processing the boron part of the boron carrier. The first time I actually operated the processing equipment in Kuopio was in 2016 and since then, I have made about 15 visits to Kuopio.”
Drug development and manufacture under the Medfiles quality system
The production of the antibody-boron conjugate molecule is a two-step process, in which the boron part of the boron carrier is produced under Medfiles’ licence and quality system for further processing by the manufacturer of the final product.
Medfiles’ adaptable cleanrooms can be furnished as required and are therefore well suited for this type of processing as well. Medfiles provides the facilities and the quality system under which the Glykos staff – who have developed the process and know it well – acts in an operative role. This type of collaboration is an ideal solution for the client’s need.
Medfiles is responsible for the GMP training of the Glykos staff and supervises the processing in a managerial role. Similarly, the associated functions related to the production process, such as material, equipment and document management, are the responsibility of the Medfiles staff.
In addition, Medfiles is responsible for the chemical and microbiological quality control analysis of the starting materials and intermediate product, as well as the coordination of stability testing and GMP consulting according to the needs of the client. In other words, Tenboron makes good use of the full service range of the Medfiles’ R&D and Laboratory Unit.
“Up to this day, this is how our cooperation has continued. However, the intention is to transfer the entire development and production process of the intermediate product and the processing responsibility to Medfiles’ production staff over the next few years. This way in the future, we will get the whole service package from Medfiles,” says Jari.
The benefits of outsourcing: risk management and cost efficiency
According to Juha, outsourcing is a sensible solution for a company that does not have a steady and constant need for manufacturing:
“It would have been much riskier and more labour-consuming to start our own manufacturing. If you had to organise the production facilities, staff and quality system yourself, it would have been a huge effort and expense. Outsourcing to Medfiles brings the necessary flexibility to our operations and is also a way to manage cost risks.”
“I find that the cooperation with Medfiles is absolutely essential for our operations. It was easy to jump in, with the quality system ready and in place,” Jari continues.
According to Jari and Juha, the cooperation has run smoothly and both look forward to continuing it.
“It has been really nice to work together. The Medfiles team is incredibly knowledgeable and easy to approach. We understand each other well. A shared mother tongue makes communication easier and reduces the risk of misunderstandings. I look forward to my next trip to Kuopio. We plan to manufacture a third production batch before the end of 2024,” Jari says.
“Also, the technical aspects related to our contract have always gone smoothly, and things have been done as agreed. Everything has worked well, and we have found a common understanding on how to do things. I look forward to continuing this good cooperation in the future,” Juha concludes.
Medfiles provides comprehensive GMP-compliant chemical and microbiological analytical services under GMP licence. Our laboratories have been GMP-certified and operating under a GMP licence since 2005. Our GMP licence also covers manufacture of investigational medicinal products for clinical trials. Our expert team provides pharmaceutical product development services from early clinical phases to marketing authorisation, for both human and veterinary products.
