Helius – first in NZ to be fully GMP certified
The country’s largest medicinal cannabis company has announced another New Zealand first. The Ministry of Health has awarded Helius Therapeutics GMP (Good Manufacturing Practice) certification for the drying and finishing of medicinal cannabis flower.
“This latest certificate moves us closer to delivering New Zealand-grown flower locally and internationally,” says Helius Therapeutics chief executive, Carmen Doran.
Helius is on track to be a global leader in the production and export of quality cannabis flower. The Auckland-based company is taking orders, with signed contracts for Helius flower already in place.
“This certification is a very significant development for Helius. We are the first New Zealand company able to manufacture a full range of medicinal cannabis products under full GMP certification which is currently the minimum quality standard in many focus export markets,” says Ms Doran.
Such key site-wide certification will see Helius significantly boost its indoor growing operations, with Kiwi-grown flower available for export alongside the six oil-based medicinal cannabis products already available. The active ingredient is extracted from biomass organically grown by Puro – a leading South Island-based cannabis cultivator – or grown at the Helius facility.
Being the only company in New Zealand to now be fully certified across its entire facility will allow Helius to further expand its product portfolio.
The CEO says once medicinal cannabis flower is in market, Helius will be among just a few medicinal cannabis companies in the world that are truly fully vertically-integrated and EU-GMP recognised, opening up access to European and Australian markets.
GMP certification for the drying and finishing of cannabis flower follows nearly two years of Helius meeting regulatory milestones and high levels of compliance after achieving its first GMP licence in July 2021.
Since being the first medicinal cannabis company in New Zealand to achieve a GMP Licence to Manufacture Medicines, the 100% Kiwi-owned private company has consistently added more GMP processes to that list. These cover the extraction of CBD and THC crude and distillate, manufacture of cannabis-based medicines, drying and processing of dried flower, and packing and distribution of medicinal cannabis products.
Late last year Helius became the first local company to receive GMP certification to produce THC extracts and manufacture medicines containing THC. This enables them to produce THC containing medicines which are both grown and made in New Zealand.
“Yes, we’ll soon be a ‘seed to sale’ company, but we see our vertical integration operation more through the lens of ‘plant to patient,” she says.
Driven by improving Kiwi patients’ quality of life, Helius began the rigorous and complex journey for GMP certification as a start-up in 2018.
“This latest announcement is testament to the culture of teamwork and excellence Helius is building. It reinforces our technical prowess not to mention our highly controlled, precision indoor growing environment which will deliver consistent all year-round results,” she says.
Carmen Doran says Helius’ GMP compliance has taken an internationally experienced leadership team as well as a commitment to work alongside the regulators with patient safety and product quality at the fore.
Helius’ operations connect cultivar breeding to yield optimisation; precision extraction of high-value cannabinoids, next-generation medicine development, GMP production, plus academic and several scientific partnerships.
Last year Helius raised $13m in capital from committed New Zealand investors, reinforcing its steadfastness and product dominance in the local market. This year the company will unleash its export strategy. More GMP certificates and manufacturing milestones will follow.
Helius is a medicines company, unleashing the power of cannabis to improve lives. Its strategy unlocks the global potential of medical-grade cannabis therapeutics, developed from New Zealand. Helius leverages vertical integration, from plant to patient. Operations connect cultivar breeding to yield optimisation, precision extraction of high-value cannabinoids, next generation medicine development, full GMP production and academic and scientific partnerships. Helius is defining the standard for trusted accessible cannabis-based medicines.