The Seneffe Manufacturing Site – Telix’s Next Big Move in Europe

1st May 2020 – Corporate Spotlight | Telix’s CEO Chris Behrenbruch comments on the Company’s next big move in Europe : the Seneffe manufacturing site.

Radiopharmaceutical manufacturing is a complex business, both in the technical aspects and the regulation of the use of radiation. Although the industrial production and use of medical isotopes are a lot less complicated than other nuclear/radioactive technology applications, there is still a significant barrier to entry to handle medical radiation at large scale, particularly in Europe.

Over the past few years, Telix has established productive relationships with some of the most important radiopharmaceutical manufacturers in Europe. The European market, although fragmented and complex due to the variation in radiation safety and handling laws amongst member states, is also one of the most important global markets for Telix’s products and is extremely vibrant from an innovation perspective. The basic challenge is that no single manufacturer has the production capacity to really deliver on Telix’s needs in Europe for both diagnostic and therapeutic products. This is partially due to the aforementioned fragmentation, but also because the industry overall is still nascent. Hence, there are relatively few examples of commercial products that have driven the business case for building production capacity until now.

Of course, all of this is about to change and there are a large number of products in the pipeline (close to 100) companies such as Telix, Novartis, ITM and others.

The decision by Telix to acquire the Seneffe site from Eckert and Ziegler, a leading isotope production company was not a trivial decision. The site was originally constructed in the late 1990s to make palladium and iodine brachytherapy seeds for treating cancer. The palladium (103Pd) was actually made onsite in two large cyclotron bunkers and this accounted for much of the radioactivity and contamination at the site. The site ceased making brachytherapy seeds in 2008 and the prior owners partially decommissioned the site, with the exception of the two cyclotron bunkers, which (it was reasoned) would not warrant removal because a new owner would want to install new cyclotrons and this would, in turn, recommence irradiation of those bunkers.

So why would Telix want to acquire such a site?

Well, the beauty of the site is that it comes with a very deep license – in fact, one of the deepest private radiation licenses for medical isotopes in Europe. Today it would be challenging to obtain approval to build and commission the site, let alone obtain approval to handle a large amount of medical radiation on an operational basis. Moreover, the site is configured to handle both radioactive metals and radio-halogens (like iodine), which are gaseous and volatile. This is a unique fit with Telix’s product portfolio which has both iodinated compounds (i.e. TLX101 for treating glioblastoma, a form of brain cancer) as well as both diagnostic (TLX250-CDx for imaging renal cancer with 89Zr) and therapeutic (TLX591 for treating prostate cancer with 177Lu) radiometal use.

What Telix has acquired is essentially a completely blank canvas for manufacturing operations. Telix has submitted a new operational plan to the nuclear regulators and waste management authorities. The license has been upgraded to reflect the operational plan for the site and Telix has commenced the process of removing one of the old cyclotrons (which is no longer operationally feasible) to make way for the installation of new production capabilities. It is worth noting that the site has capacity for up to 8 medium-energy cyclotrons on site. That’s a LOT of production firepower if Telix needs it in the future, and very rare!

So, what next?

Well, over the next 12-15 months the focus is to get the old cyclotrons out and pave the way for new production systems. Telix made a commitment to the various regulators that the company would get a move on with this as part of the acquisition of the site, and this work has started. Both the prostate and kidney imaging agents will be produced and distributed out of this site (TLX591-CDx and TLX250-CDx) and Telix needs to be ready in about 18 months to produce these products in commercial quantities. Our manufacturing team has a big job ahead!

Personally, I love this site. Its location is amazing and we couldn’t have asked for a site layout better suited to our product pipeline. We can even hit 5 countries and a couple of dozen major hospitals within about 100km driving radius so in addition to working with our network of distribution and logistics companies, we expect to some degree of product distribution directly out of the site. This is not only good for cost-effective commercial operations but great for facilitating research collaborations.   Brussels and Charleroi airports (20 minutes away) get us to the rest of Europe and beyond

Exciting Times

Christian Behrenbruch, Ph.D