The Nanaimo, Canada-headquartered firm supplies pharmaceutical grade cannabis for the treatment of a range of disorders, including for paediatric epilepsy and post-traumatic stress disorder (PTSD). It also has several oral cannabis-extract based drugs in clinical trials.
Tilray makes its products and drug candidates at a facility in British Columbia, which became the only good manufacturing practice (GMP) certified cannabis production site in North America after an inspection by the European Medicines Agency (EMA) in December.
The facility is 70,000 sq ft with 40 plant cultivation rooms and three laboratory spaces for extraction, manufacturing and packaging.
CEO Brendan Kennedy told us: “the facility is a unique combination of industrial agriculture and pharma. In fact Tilray is the only GMP-certified producer of whole flower cannabis products - oils, extracts and other formulations - in the world. ”
This was echoed by Joshua Eades, CSO of Tilray, who told us the capsules Tilray uses to produce its candidate drug are also manufactured onsite.
Quality of extracts
The facility also houses a QA/QC laboratory. Eades told us each the potency of batch of product is tested using liquid chromatography analysis (LC), adding that atomic absorption spectroscopy is also used to test for heavy metals.
The firm also tests for aflatoxin, a potent human carcinogen produced by fungi.
Eades explained: “because the APIs are extracted from a plant, we have to test for aflatoxin to make sure there's no contamination.”
Primarily the facility uses the Agilent 1220 c LC unit, along with other instruments from Agilent: “the nice thing about this is that it allows us to use the same software program – ChemStation.”
Gas chromatography is also used for non-routine testing, for solvent residue for example - to make sure the excipients in the product are below acceptable limits.
Distribution
Tirlay has contracted cold chain logistics supplier World Courier to ship its candidate cannabinoid-based productsa to trial sites.
Eades explained that: “We’re using cold chain on all the clinical products, as we're still gathering our stability data to see how they behave under different temperatures.”
Distribution of Tilray’s medical grade cannabis products is carried out by a number of contractors according to Kennedy, who told us the firm has 20,000 patients it supplies within Canada.
“We will continue to export from Canada, although it's likely we will build additional distribution [infrastructure] in the next 12 - 18 months.”
