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Ahead of the release of Prohibition Partners upcoming Global Cannabis Report: 5th Edition, we sat down with Sebastian Zeller, Managing Director of Canexis Pharma AG, a Swiss-based leader in medical cannabis production. Canexis is at the forefront of refining cannabis into high-purity extracts and active pharmaceutical ingredients (APIs) like cannabidiol and dronabinol.
This extract interview from the report, which can now be preordered here, explores not only their groundbreaking approaches to extraction, compliance, and market development but also their vision for the future of medical cannabis and why Switzerland is poised to become a leading light in medical cannabis across Europe.
Can you walk us through the key innovations in Canexis Pharma AG’s processes?
“Well, our process has a few key differentiators compared to others. First, we use an innovative hydrocarbon extraction method, which produces terpene-rich extracts. After that, we perform winterisation to get rid of apolar impurities such as waxes, followed by a gentle decarboxylation and short-path distillation.
“Traditional extraction methods often use ethanol, which has two significant drawbacks: the crude product ends up with almost no terpene content and potentially high levels of chlorophyll, which is leading to a bitter taste.
“The distillate may also still contain chlorophyll or waxes, which leads to a darker appearance, or higher levels of the degradation product CBN due to the fact that ethanol-based extraction processes usually need longer and higher temperatures. These typical impurities found in some extracts and distillates are not present in ours. In our process, we use a double-stage distillation to separate terpenes and other plant residues from the cannabis distillate. This allows us to achieve a purity of around 85% for THC distillates and approximately 80% for CBD distillates at a scale of 10kg/hour.
“Moreover, we have the capability to crystallise CBD distillate to pharmaceutical-grade Cannabidiol Ph. Eur. standards. Very soon—hopefully by the end of the first quarter or early in the second quarter of 2025—we aim to introduce naturally derived dronabinol, which will be purified with crystallisation directly from the extract, which is quite unique.”
How did you develop this cutting-edge method of extraction?
“Well, we’ve reached this point through a lot of experience, starting with CBD extraction in 2017. Since that time, we have been in exchange with other companies from the US and were able to see which pathways led to the best success in the very mature US market. Even though the US market can hardly be compared to the global medical market, we believe that the US recreational market led to the most developed processes and techniques when it comes to extraction and cultivation, which ends up in the best consumer products.
“Through these exchanges, we have gained valuable insights and implemented various scale-ups over the past few years, both in theory and practice. In 2023, we scaled up production at Canexis’ new facility, processing approximately 9,000 kg of crude CBD extract. This allowed us to refine our current setup, identify the optimal parameters for achieving the highest quality product, and validate the process under EU GMP standards.”
Sebastian Zeller, Managing Director and Member of the Board of Directors
How does compliance with EU GMP standards influence your operations and positioning within the European cannabis market?
“Each company that works under EU GMP knows that compliance has a huge impact on all kinds of daily operations. It needs a lot of knowledge to set up and maintain the GMP standard, and this knowledge should be expanded all the time.
“It is crucial to have a clear understanding of what you are doing from the outset, particularly regarding processes and products. Once a process is validated, any changes may require revalidation, which can be both time-consuming and costly. Therefore, processes are rigorously tested, and in-depth knowledge is developed before selecting and qualifying the appropriate equipment. Only after gaining comprehensive process knowledge on this equipment is the process ultimately validated.
“We’ve now validated the GMP process for Cannabidiol Ph. Eur. and are in the ongoing validation phase for THC and CBD extracts, as well as THC and CBD distillates and the adjusted extracts thereof. We take GMP compliance very seriously, adhering strictly to EU GMP standards. This includes conducting stability studies in line with ICH guidelines. Additionally, we plan to develop drug master files for our most significant products in the coming year.”
Can you tell us more about these?
“The cannabidiol will be available starting in January, with 12 months of stability initially. The stability study is ongoing, and we expect to reach three to five years of stability in the end. THC and CBD extracts, as well as distillates, are currently undergoing stability testing and will be available as bulk APIs with at least one year of stability by the middle of this year.
“For products like oils or flowers that can be prescribed directly in markets like the UK and Germany, we’ll begin stability studies and validation in February. We have a wide range of products rolling out at the moment— Cannabidiol Ph. Eur. is ready, and the rest will join our portfolio with robust stability data by mid-2025. Lastly, we’ll also start an ongoing stability study for dronabinol by mid-2025, which should then have a marketable stability of one year by the end of 2025.
“At the same time, we’re also seeing increasing interest in GMP-certified flowers. Switzerland has traditionally been a strong production hub for CBD flowers, so we’re now partnering with local companies to establish a medical cannabis flower supply chain. It’s busy on all fronts, but we’re making great progress.”
Looking ahead, how do you see the Swiss cannabis industry developing over the next few years?
“We believe that Switzerland is an excellent location for our operations. We assume that quality and reliability will be the key to success in the pharmaceutical area, and in Switzerland, the quality awareness is very pronounced.
“Moreover, Switzerland already has an existing cluster for the pharmaceutical industry, which means there is access to knowledge, well-educated employees, service providers, suppliers, and other companies acting in similar segments within the sector.
“Furthermore, there is also an existing cannabis cluster in Switzerland that has already made it the largest indoor CBD flower producer in Europe, potentially even globally.
“With this in mind, we believe Switzerland is poised to become a critical player in the European medical cannabis market, distinguished by its quality, reliability, and strategic central location within Europe.”
Similarly, what are your expectations for the development of the extraction sector?
“The medical cannabis market has been steadily growing and evolving for years, with more data being collected and an increasing number of indications and success stories gaining attention.
“Currently, cannabis flower remains a popular prescription choice, but trends in more mature markets, such as North America, indicate that as markets mature and product knowledge improves, demand for extract-based products will rise. Extracts offer precise dosage control and eliminate the risks associated with inhalation, making them particularly suited for medical applications where such precision is crucial.
“We anticipate that the global extract market will expand significantly in the coming years. Additionally, while the current medical cannabis market primarily relies on prescribed medications, we foresee a shift towards finished pharmaceuticals supported by clinical trials and clear indications. This development will drive demand for highly refined cannabis extracts and pure cannabinoids, ultimately enabling a broader range of patients to access effective medical treatments.”
What sets Canexis Pharma AG apart from other companies in the industry?
“What makes us unique is our core focus on extracts. We firmly believe in the future of finished pharmaceuticals utilising cannabis APIs. This strong emphasis on extracts and purified APIs like cannabidiol and dronabinol sets us apart. In markets like Switzerland, for example, the system is formulary-based, meaning doctors prescribe something specifically tailored for the patient because there aren’t many finished pharmaceuticals available yet.
“We’re confident this will change. The prescribing market is already significant, while there are just some limited numbers of finished pharmaceuticals. We believe that in the next five to ten years, the market will see a surge in various finished pharmaceutical products. Our goal is to be a key supplier for these products by providing the highest quality APIs, consistent volumes, and large-scale production. capabilities. Our production can process up to one tonne of cannabis flower per day, resulting in substantial output.
“What also makes us different is our extensive experience in the cannabis industry since 2017. We deeply understand what we do and are committed to advancing the scientific and medical applications of cannabinoids. We strictly adhere to GMP standards—not just meeting the minimum requirements, as many do, but going above and beyond. This commitment ensures we’re prepared to meet the needs of larger pharmaceutical companies that take quality seriously and don’t just focus on minimising costs.
“Moreover, as an independent company, we are not seeking any form of exit strategy. Instead, we remain focused on our core business and our long-term vision of contributing to the growth and evolution of cannabinoid-based pharmaceuticals.”
“}]] Ahead of the release of Prohibition Partners upcoming Global Cannabis Report: 5th Edition, we sat down with Sebastian Zeller, Managing Director of Canexis Pharma AG, a Swiss-based leader in medical Read More
