Forward of the discharge of Prohibition Companions upcoming International Hashish Report: fifth Version, we sat down with Sebastian Zeller, Managing Director of Canexis Pharma AG, a Swiss-based chief in medical hashish manufacturing. Canexis is on the forefront of refining hashish into high-purity extracts and lively pharmaceutical components (APIs) like cannabidiol and dronabinol.

This extract interview from the report, which might now be preordered right here, explores not solely their groundbreaking approaches to extraction, compliance, and market growth but additionally their imaginative and prescient for the way forward for medical hashish and why Switzerland is poised to grow to be a number one gentle in medical hashish throughout Europe. 

Are you able to stroll us by the important thing improvements in Canexis Pharma AG’s processes?

“Nicely, our course of has just a few key differentiators in comparison with others. First, we use an modern hydrocarbon extraction methodology, which produces terpene-rich extracts. After that, we carry out winterisation to eliminate apolar impurities akin to waxes, adopted by a mild decarboxylation and short-path distillation.

“Conventional extraction strategies usually use ethanol, which has two important drawbacks: the crude product finally ends up with nearly no terpene content material and probably excessive ranges of chlorophyll, which is resulting in a bitter style.

“The distillate might also nonetheless comprise chlorophyll or waxes, which ends up in a darker look, or increased ranges of the degradation product CBN on account of the truth that ethanol-based extraction processes often want longer and better temperatures. These typical impurities present in some extracts and distillates should not current in ours. In our course of, we use a double-stage distillation to separate terpenes and different plant residues from the hashish distillate. This permits us to attain a purity of round 85% for THC distillates and roughly 80% for CBD distillates at a scale of 10kg/hour.

“Furthermore, now we have the potential to crystallise CBD distillate to pharmaceutical-grade Cannabidiol Ph. Eur. requirements. Very quickly—hopefully by the tip of the primary quarter or early within the second quarter of 2025—we purpose to introduce naturally derived dronabinol, which will probably be purified with crystallisation immediately from the extract, which is kind of distinctive.”

How did you develop this cutting-edge methodology of extraction?

“Nicely, we’ve reached this level by loads of expertise, beginning with CBD extraction in 2017. Since that point, now we have been in alternate with different firms from the US and have been capable of see which pathways led to the very best success within the very mature US market. Despite the fact that the US market can hardly be in comparison with the worldwide medical market, we imagine that the US leisure market led to essentially the most developed processes and strategies in the case of extraction and cultivation, which leads to the very best shopper merchandise.

“By means of these exchanges, now we have gained useful insights and applied numerous scale-ups over the previous few years, each in principle and apply. In 2023, we scaled up manufacturing at Canexis’ new facility, processing roughly 9,000 kg of crude CBD extract. This allowed us to refine our present setup, establish the optimum parameters for attaining the best high quality product, and validate the method below EU GMP requirements.”

How does compliance with EU GMP requirements affect your operations and positioning throughout the European hashish market?

“Every firm that works below EU GMP is aware of that compliance has a big impact on every kind of every day operations. It wants loads of data to arrange and keep the GMP customary, and this information ought to be expanded on a regular basis.

“It’s essential to have a transparent understanding of what you might be doing from the outset, notably relating to processes and merchandise. As soon as a course of is validated, any modifications could require revalidation, which could be each time-consuming and expensive. Subsequently, processes are rigorously examined, and in-depth data is developed earlier than choosing and qualifying the suitable gear. Solely after gaining complete course of data on this gear is the method in the end validated.

“We’ve now validated the GMP course of for Cannabidiol Ph. Eur. and are within the ongoing validation part for THC and CBD extracts, in addition to THC and CBD distillates and the adjusted extracts thereof. We take GMP compliance very critically, adhering strictly to EU GMP requirements. This contains conducting stability research in step with ICH pointers. Moreover, we plan to develop drug grasp information for our most vital merchandise within the coming yr.”

Are you able to inform us extra about these?

“The cannabidiol will probably be obtainable beginning in January, with 12 months of stability initially. The soundness research is ongoing, and we anticipate to achieve three to 5 years of stability in the long run. THC and CBD extracts, in addition to distillates, are at present present process stability testing and will probably be obtainable as bulk APIs with no less than one yr of stability by the center of this yr.

“For merchandise like oils or flowers that may be prescribed immediately in markets just like the UK and Germany, we’ll start stability research and validation in February. We’ve got a variety of merchandise rolling out for the time being— Cannabidiol Ph. Eur. is prepared, and the remainder will be a part of our portfolio with strong stability information by mid-2025. Lastly, we’ll additionally begin an ongoing stability research for dronabinol by mid-2025, which ought to then have a marketable stability of 1 yr by the tip of 2025.

“On the identical time, we’re additionally seeing growing curiosity in GMP-certified flowers. Switzerland has historically been a robust manufacturing hub for CBD flowers, so we’re now partnering with native firms to ascertain a medical hashish flower provide chain. It’s busy on all fronts, however we’re making nice progress.”

Wanting forward, how do you see the Swiss hashish business growing over the subsequent few years?

“We imagine that Switzerland is a wonderful location for our operations. We assume that high quality and reliability would be the key to success within the pharmaceutical space, and in Switzerland, the standard consciousness could be very pronounced.

“Furthermore, Switzerland already has an current cluster for the pharmaceutical business, which suggests there may be entry to data, well-educated staff, service suppliers, suppliers, and different firms performing in comparable segments throughout the sector.

“Moreover, there may be additionally an current hashish cluster in Switzerland that has already made it the biggest indoor CBD flower producer in Europe, probably even globally.

“With this in thoughts, we imagine Switzerland is poised to grow to be a crucial participant within the European medical hashish market, distinguished by its high quality, reliability, and strategic central location inside Europe.”

Equally, what are your expectations for the event of the extraction sector?

“The medical hashish market has been steadily rising and evolving for years, with extra information being collected and an growing variety of indications and success tales gaining consideration.

“At the moment, hashish flower stays a well-liked prescription alternative, however traits in additional mature markets, akin to North America, point out that as markets mature and product data improves, demand for extract-based merchandise will rise. Extracts provide exact dosage management and get rid of the dangers related to inhalation, making them notably fitted to medical purposes the place such precision is essential.

“We anticipate that the worldwide extract market will develop considerably within the coming years. Moreover, whereas the present medical hashish market primarily depends on prescribed medicines, we foresee a shift in direction of completed prescribed drugs supported by medical trials and clear indications. This growth will drive demand for extremely refined hashish extracts and pure cannabinoids, in the end enabling a broader vary of sufferers to entry efficient medical therapies.”

What units Canexis Pharma AG aside from different firms within the business?

“What makes us distinctive is our core deal with extracts. We firmly imagine in the way forward for completed prescribed drugs utilising hashish APIs. This sturdy emphasis on extracts and purified APIs like cannabidiol and dronabinol units us aside. In markets like Switzerland, for instance, the system is formulary-based, which means medical doctors prescribe one thing particularly tailor-made for the affected person as a result of there aren’t many completed prescribed drugs obtainable but.

“We’re assured this can change. The prescribing market is already important, whereas there are just a few restricted numbers of  completed prescribed drugs. We imagine that within the subsequent 5 to 10 years, the market will see a surge in numerous completed pharmaceutical merchandise. Our aim is to be a key provider for these merchandise by offering the best high quality APIs, constant volumes, and large-scale manufacturing. capabilities. Our manufacturing can course of as much as one tonne of hashish flower per day, leading to substantial output.

“What additionally makes us totally different is our in depth expertise within the hashish business since 2017. We deeply perceive what we do and are dedicated to advancing the scientific and medical purposes of cannabinoids. We strictly adhere to GMP requirements—not simply assembly the minimal necessities, as many do, however going above and past. This dedication ensures we’re ready to satisfy the wants of bigger pharmaceutical firms that take high quality critically and don’t simply deal with minimising prices.

“Furthermore, as an unbiased firm, we’re not in search of any type of exit technique. As an alternative, we stay centered on our core enterprise and our long-term imaginative and prescient of contributing to the expansion and evolution of cannabinoid-based prescribed drugs.”